FDA Update
FDA Approves First-Line Ivosidenib for IDH1-Mutated AML
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
FDA Approves New Trastuzumab Biosimilar
On June 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-anns (Kanjinti) for all approved indications of the reference product trastuzumab (Herceptin): for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction a...
FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma
On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was approved for us...
FDA Announces Project Facilitate to Access Investigational Therapies for Patients With Cancer
The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) recently announced a new pilot program to assist oncology health-care professionals in requesting access to unapproved therapies for patients with cancer. A new call center designated Project Facilitate will be a single...
Alpelisib Plus Fulvestrant Approved for PIK3CA-Mutated Breast Cancer
On May 24, the U.S. Food and Drug Administration (FDA) approved the PIK3CA inhibitor alpelisib (Piqray) tablets to be used in combination with the FDA-approved endocrine therapy fulvestrant to treat postmenopausal women and men with hormone receptor–positive, HER2-negative, PIK3CA-mutated, advanced ...
NovoTTF-100L System in Combination With Chemotherapy Approved for Malignant Pleural Mesothelioma
On May 23, the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma. NovoTTF-100L is a noninvasive, antimitot...
Ruxolitinib Approved for Acute Graft-vs-Host Disease
On May 24, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi) for steroid-refractory acute graft-vs-host disease (GVHD) in adult and pediatric patients 12 years and older. Approval was based on the REACH1 trial/Study INCB 18424-271, an open-label, single-arm, multicenter stud...
FDA Oncology Drug Approvals Granted Between May 21, 2018 and May 14, 2019
The ASCO Post
Over the past year (May 2018–May 2019), the U.S. Food and Drug Administration (FDA) granted approval and accelerated approval to a number of new oncology drugs and biosimilars. Here we list the new FDA-approved labels and indications. AVELUMAB (BAVENCIO) and AXITINIB (INLYTA) has been approved as a...
FDA Approves T-DM1 for HER2-Positive Early Breast Cancer
On May 3, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (T-DM1; Kadcyla) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based treatment. Patients should be se...
FDA Approves Avelumab/Axitinib Combination for Advanced Renal Cell Carcinoma
On May 14, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) in combination with axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti–programmed cell death ligand 1 (PD-L1) therapy as pa...
FDA Approves First-Line Ivosidenib for IDH1-Mutated AML
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
FDA Expands Pembrolizumab Indication for NSCLC in First-Line Setting
On April 14, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or those with metastatic NSCLC. Patients...
FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL
On May 15, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on the CLL14 tr...
FDA Approves Ramucirumab for Hepatocellular Carcinoma
ON MAY 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza) as a single agent for hepatocellular carcinoma in patients who have an alpha fetoprotein (AFP) level ≥ 400 ng/mL and have been previously treated with sorafenib. REACH-2 Trial APPROVAL WAS based on the REACH-2 t...
FDA Advances Policy Changes to Modernize Mammography Services
ON MARCH 27, 2019, the U.S. Food and Drug Administration (FDA) announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care. For the first time in more than 20 year...
FDA Grants Accelerated Approval to Erdafitinib for Metastatic Urothelial Carcinoma
On April 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to erdafitinib (Balversa) for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations that has progressed during or following platinum-containing chem...
FDA Oncology Center of Excellence Issues Annual Report
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has issued its 2018 Annual Report,1 including updates on regulatory reviews and initiatives, OCE programs, guidances, and more. The OCE is tasked with clinical medical oncology reviews, irrespective of whether the produ...
FDA Approves Atezolizumab for Extensive-Stage Small Cell Lung Cancer
The ASCO Post
On March 18, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer. Approval was based on the IMpower133 study (ClinicalTrials.gov ...
FDA Warning: Investigational Use of Venetoclax in Multiple Myeloma
The ASCO Post
On March 21, 2019, the U.S. Food and Drug Administration (FDA) posted a safety statement on the investigational use of venetoclax in multiple myeloma. The statement alerts health-care professionals and patients about the suspension of the BELLINI trial (ClinicalTrials.gov identifier NCT02755597) of...
FDA Commissioner Scott Gottlieb, MD, Resigns
The ASCO Post
ON MARCH 5, 2019, Scott Gottlieb, MD, announced his resignation as Commissioner of the U.S. Food and Drug Administration (FDA), a post he began in 2017. Dr. Gottlieb’s resignation will be effective in April. In a resignation letter to Alex M. Azar II, Secretary of Health and Human Services (HH...
FDA Grants Accelerated Approval to Atezolizumab/ Nab-paclitaxel in Triple-Negative Breast Cancer
The ASCO Post
ON MARCH 8, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) for the treatment of adults with unresectable, locally advanced or metastatic, PD-L1–positive triple-negative breast cancer. PD-L1 status is determined by a...
FDA Approves Trifluridine/Tipiracil for Recurrent, Metastatic Gastric and GEJ Adenocarcinoma
The ASCO Post
ON FEBRUARY 22, the U.S. Food and Drug Administration approved trifluridine/tipiracil tablets (Lonsurf)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (G...
FDA Approves Split-Dosing Regimen of Therapy for Multiple Myeloma
The ASCO Post
ON FEBRUARY 12 , 2019, the U.S. Food and Drug Administration (FDA) approved a split-dosing regimen for daratumumab (Darzalex), providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. Daratumumab is a CD38-directed antibody...
FDA Approves Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL
The ASCO Post
ON JANUARY 28, 2019, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica), a Bruton’s tyrosine kinase inhibitor, in combination with obinutuzumab in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first approval of ...
Direct-to-Consumer Genetic Test on Hereditary Colorectal Cancer Syndrome Receives FDA Clearance
The ASCO Post
ON JANUARY 22, 2019, 23andMe received U.S. Food and Drug Administration (FDA) clearance for a genetic health risk report on the hereditary colorectal cancer syndrome MUTYH-associated polyposis. The clearance follows the FDA’s authorization for 23andMe’s BRCA1/BRCA2 (Selected Variants) Genetic Health...
FDA Approves Cabozantinib in Previously Treated Hepatocellular Carcinoma
The ASCO Post
On January 14, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib. The FDA’s approval of this oral tyrosine kinase inhibitor was based on the results of the phase III CELESTI...
Priority Review for Atezolizumab in Combination With Chemotherapy for Small Cell Lung Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer. The FD...
Statement From FDA Commissioner on In Vitro Companion Diagnostics
The ASCO Post
FDA Commissioner Scott Gottlieb, MD, recently issued the following statement on developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products: “With a new draft guidance document that the FDA issued … our aim is to make it easier to get class labe...
FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer
The ASCO Post
On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications: Adjuvant breast cancer of HER2-overexpressing, node-positive or node-negative (estrogen receptor/pr...
Priority Review for Quizartinib in Relapsed or Refractory FLT3-ITD–Positive AML
The ASCO Post
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) accepted a new drug application and granted Priority Review to quizartinib, a FLT3 inhibitor, for the treatment of adult patients with relapsed or refractory FLT3-ITD–positive acute myeloid leukemia (AML). The FDA is expected to make a decision on approval...
Breakthrough Therapy Designation for Brentuximab Vedotin in Front-Line Treatment of Peripheral T-Cell Lymphomas
The ASCO Post
THE FDA recently granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in ...
FDA Approves Lorlatinib for Second- or Third-Line Treatment of ALK-Positive Metastatic NSCLC
The ASCO Post
On November 2, 2018, the U.S. Food and Drug Administration granted accelerated approval to lorlatinib (Lorbrena) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib (Xalkori) and at least one other ALK...
FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
The ASCO Post
ON NOVEMBER 6, 2018, following Priority Review, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least...
FDA Expands Approved Use of Brentuximab Vedotin in Some Types of PTCL
The ASCO Post
ON NOVEMBER 16, 2018, the U.S. Food and Drug Administration (FDA) expanded the approved use of brentuximab vedotin (Adcetris) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL)—adults with previously untreated systemic anaplastic lar...
FDA Approves Pembrolizumab for Hepatocellular Carcinoma Previously Treated With a Kinase Inhibitor
The ASCO Post
ON NOVEMBER 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with the kinase inhibitor sorafenib (Nexavar). KEYNOTE-224 APPROVAL WAS based on KEYNOTE-224, a sin...
FDA Approves Levoleucovorin for Treatment in Osteosarcoma, Colorectal Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) recently approved levoleucovorin (Khapzory) injection, a folate analog, for three indications: rescue after high-dose methotrexate therapy in patients with osteosarcoma; diminishing the toxicity associated with overdosing on folic acid antagonists or impai...
FDA Releases Draft Guidance for Clinical Trial Design
The ASCO Post
The U.S. Food and Drug Administration (FDA) announced the availability of the Draft Guidance Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics. Master protocol trial designs are complex due to the concurrent evaluation of multiple dru...
Talazoparib Approved for BRCA-Mutated, HER2-Negative Breast Cancer
The ASCO Post
On October 16, 2018, the U.S. Food and Drug Administration approved talazoparib (Talzenna), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. Patients must be sele...
FDA Approves Duvelisib for Adult Patients With Relapsed or Refractory Hematologic Malignancies
The ASCO Post
ON SEPTEMBER 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib (Copiktra) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Duvelisib also received accelerated ap...
FDA Approves Dacomitinib for Metastatic Non–Small Cell Lung Cancer
The ASCO Post
ON SEPTEMBER 27, 2018, the U.S. Food and Drug Administration (FDA) approved dacomitinib tablets (Vizimpro) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations...
FDA Approves Moxetumomab Pasudotox-tdfk for the Treatment of Hairy Cell Leukemia
The ASCO Post
ON SEPTEMBER 13, 2018, the U.S. Food and Drug Administration (FDA) approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including...
FDA Approves First Nonchemotherapy Combination Regimen for Patients With Waldenström’s Macroglobulinemia
The ASCO Post
ON AUGUST 27, 2018, the U.S. Food and Drug Administration (FDA) approved the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) for patients with Waldenström’s macroglobulinemia. The recent approval expands the label for ibrutinib in Waldenström’s macroglobulinemia beyond its current appro...
Recent Drug Approvals and Revisions in Prescribing Information
The ASCO Post
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) issued the following approvals and prescribing information revisions in August 2018. Lenvatinib Approved for Unresectable Hepatocellular Carcinoma THE FDA approved lenvatinib (Lenvima) for the first-line treatment of patients with unresectable hepatocel...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
The ASCO Post
On August 8, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use in the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new treatme...
FDA Approves HPV Test for First-Line Cervical Cancer Screening
The ASCO Post
ON JULY 30, 2018, Roche announced approval by the U.S. Food and Drug Administration (FDA) of its cobas HPV Test in first-line screening for cervical cancer in women 25 years and older using cervical specimens collected in SurePath preservative fluid. The FDA first approved the cobas HPV test witho...
FDA Approves Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia
The ASCO Post
On July 20, 2018, the U.S. Food and Drug Administration approved ivosidenib (Tibsovo) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Approval was based on an open-label, single-arm, multicenter clinic...
FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
The ASCO Post
On July 18, 2018, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali), in combination with an aromatase inhibitor for pre/perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based thera...
FDA Approves First Treatment for Rare Adrenal Tumors
The ASCO Post
On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved iobenguane I 131 injection (Azedra) for intravenous use in the treatment of adults and adolescents aged 12 and older with unresectable pheochromocytoma or paraganglioma that have spread beyond the original tumor site and require ...
Nivolumab Plus Low-Dose Ipilimumab Approved for Second-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer
On July 11, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the treatment of adult and pediatric patients aged 12 years and older with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) metastatic colorectal cance...
FDA Approves Enzalutamide for Castration-Resistant Prostate Cancer
ON JULY 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi) for patients with castration-resistant prostate cancer (CRPC). This approval broadens the indicated patient population to include patients with either nonmetastatic CRPC or metastatic CRPC. Enzalutamide was ...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) in patients with advanced BRAF V600–mutant melanoma, as detected by an FDA-approved test.1 Dual targeting of the MAPK path...
Pembrolizumab Receives FDA Approval for Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma, Advanced Cervical Cancer
THE U.S. FOOD and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or who have relapsed after two or more prior lines of therapy on June 13, 2018. The newest ...
FDA Approves Bevacizumab in Combination With Chemotherapy for Ovarian Cancer
ON JUNE 13, 2018, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) for the treatment of patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV d...
FDA Approves Biosimilar to Pegfilgrastim to Reduce Risk of Infection During Myelosuppressive Chemotherapy
On June 4, the U.S. Food and Drug Administration (FDA) approved pegfilgrastim-jmdb (Fulphila) as the first biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection as suggested by febrile neutropenia in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy...
FDA Oncology Drug Approvals Granted Between June 2017 and May 16, 2018
The ASCO Post
Over the past year (June 2017–May 2018), the U.S. Food and Drug Administration (FDA) granted approval to a number of new oncology drug products, including several biosimilar products. Here we provide the labeling approved for these novel drugs and new indications. EPOETIN ALFA-EPBX (RETACRIT) rece...
FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma
On May 1, 2018, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell...
FDA Approves Daratumumab/VMP Combination for Newly Diagnosed Multiple Myeloma
On May 7, the U.S. Food and Drug Administration(FDA) approved daratumumab (Darzalex) in combination with bortezomib (Velcade), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autolog...
FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia
On May 15, 2018, the U.S. Food and Drug Administration (FDA) approved epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/-Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. The biosimilar is also...
FDA Approves Drug Combination for Adjuvant Treatment of BRAF V600–Mutant Melanoma
On April 30, 2018, the U.S. Food and Drug Administration (FDA) approved dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and lymph node involvement following c...
FDA Expands Approval of Brentuximab Vedotin in Classical Hodgkin Lymphoma
The ASCO Post
ON MARCH 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris), an antibody-drug conjugate, to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. Brentuximab vedotin combines an antibody and dr...
FDA Expands Nilotinib Indication to Pediatric Patients With CML
The ASCO Post
On March 22, the U.S. Food and Drug Administration (FDA) expanded the indication for nilotinib (Tasigna) to include treatment of first- and second-line pediatric patients 1 year of age or older with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in the chronic phase. In the Unite...
FDA Approves Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer
The ASCO Post
On February 26, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer. MONARCH 3 Approva...
FDA Grants Orphan Drug Designation to YS-ON-001 for the Treatment of Pancreatic Cancer
The ASCO Post
On February 26, Yisheng Biopharma Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to its lead immuno-oncology candidate, YS-ON-001, for the treatment of pancreatic cancer. YS-ON-001 is a clinical-stage immuno-oncology biologic product with...
FDA Accepts NDA, Grants Priority Review for Ivosidenib in Relapsed or Refractory IDH1-Mutated AML
The ASCO Post
On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review a...
Clinical Hold on BPX-501 Trials in the United States Announced
The ASCO Post
On January 30, Bellicum Pharmaceuticals announced it has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501—an agent being studied to improve outcomes for patients undergoing stem cell transplant who lack a matched donor—have been placed on a clinical hold ...
FDA Approves Abiraterone Acetate Plus Prednisone for High‑Risk Metastatic Castration-Sensitive Prostate Cancer
The ASCO Post
ON FEBRUARY 7, 2018, the U.S. Food and Drug Administration (FDA) approved abiraterone acetate (Zytiga) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer. The FDA initially approved abiraterone acetate with prednisone in 2011 for patients with meta...
FDA Takes Steps to Improve Transparency in Clinical Trial Information Related to New Drugs
The ASCO Post
As part of the U.S. Food and Drug Administration’s (FDA) efforts to enhance transparency around its drug-approval decisions, the FDA is exploring new ways to build on its obligation to share information about product approvals, as announced by FDA Commissioner Scott Gottlieb, MD. The FDA is foc...
FDA Approves Radiopharmaceutical for Rare Gastrointestinal Cancers
The ASCO Post
On January 26, 2018, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The drug is indicated for adult patients with somatostatin receptor–positive GEP-NETs. GEP-NETs can be present...
FDA Approves Afatinib for Previously Untreated, Metastatic NSCLC With Other Nonresistant EGFR Mutations
The ASCO Post
On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib (Gilotrif) for a broadened indication in first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR) mutations ...
FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
The ASCO Post
On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who h...
FDA Approves Arsenic Trioxide With Tretinoin for First-Line Treatment of Acute Promyelocytic Leukemia
The ASCO Post
ON JANUARY 15, 2018, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the treatment of adults with newly diagnosed low-risk acute promyelocytic leukemia whose disease is characterized by the presence of the t(15...
FDA Approves Cabozantinib for First-Line Treatment of Advanced Renal Cell Carcinoma
The ASCO Post
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular -approval to cabozantinib -(Cabometyx) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced RCC who have receiv...
FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer
The ASCO Post
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Approval ...
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
The ASCO Post
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). Approval was based on data from an open-label, rand...
FDA Approves First Biosimilar for the Treatment of Certain Breast and Stomach Cancers
The ASCO Post
On December 1, 2017, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. The dru...
FDA Announces Approval, CMS Proposes Coverage of Diagnostic Test for Cancer Biomarkers
The ASCO Post
On November 30, the U.S. Food and Drug Administration (FDA) approved CDx (F1CDx), a breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The Centers for Medicare & Med...
FDA Approves CAR T-Cell Therapy for Adults With Certain Types of Large B-Cell Lymphoma
The ASCO Post
ON OCTOBER 18, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Axicabt...
FDA Approvals in November 2017: Novel Drugs, New Indications
The ASCO Post
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) approved a number of novel drugs and new indications in November 2017. Several of them are listed here. Fulvestrant/Abemaciclib Combination in Breast Cancer ON NOVEMBER 15 , the FDA approved fulvestrant (Faslodex) in combination with abemaciclib (Ver...
FDA Approves Novel Therapies for Lymphoma Indications
The ASCO Post
IN OCTOBER, the U.S. Food and Drug Administration (FDA) approved two novel agents for lymphoma indications: -acalabrutinib (Calquence), a kinase inhibitor, for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy; and axicabtagene ciloleucel (Yescarta), a ...
New Biosimilar Educational Materials for Health-Care Professionals From the FDA
The ASCO Post
The U.S. Food and Drug Administration (FDA) has announced the release of new educational materials for health-care professionals about biosimilar and interchangeable products. The agency developed these educational materials to help increase understanding about these important new types of medica...
FDA Approves Intravenous Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting
The ASCO Post
ON OCTOBER 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including hig...
FDA Conducts Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online
The ASCO Post
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics, a...
FDA Awards Grants for Clinical Trials to Stimulate Product Development for Rare Diseases
The ASCO Post
THE U.S. FOOD and Drug Administration (FDA) has awarded numerous new clinical trial research grants, totaling more than $22 million over the next 4 years, to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and ...
FDA Approves Copanlisib for Relapsed Follicular Lymphoma
The ASCO Post
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) has granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. Copanlisib is a kinase inhibitor that works by blocking several enzymes that p...
FDA Grants Accelerated Approval to Nivolumab for Hepatocellular Carcinoma Previously Treated With Sorafenib
The ASCO Post
ON SEPTEMBER 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib (Nexavar). CheckMate 040 APPROVAL WAS BASED on a 154-patient subgroup ...
FDA Expands Approval of Ipilimumab to Pediatric Patients 12 Years and Older
The ASCO Post
On July 24, the U.S. Food and Drug Administration (FDA) expanded the indication for ipilimumab (Yervoy) injection for intravenous use now to include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Ipilimumab was evaluated in 2 trials of pediatr...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced Gastric Cancer
The ASCO Post
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed cell death ligand 1 (PD-L1) as...
FDA Recent Approvals Include First Oncology Biosimilar
The ASCO Post
ON SEPTEMBER 14, 2017, the U.S. Food and Drug Administration (FDA) approved bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the United States for the treatment of cancer. “Bri...
Recent FDA Actions Include New Formulation, Expanded Indications for Oncology-Hematology Drug Products
The ASCO Post
The U.S. Food and Drug Administration (FDA) recently granted approval to olaparib tablets (Lynparza) as a maintenance therapy for ovarian cancer and to inotuzumab ozogamicin (Besponsa), for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). O...
FDA Approves Betrixaban for Prophylaxis of Venous Thromboembolism
The ASCO Post
ON JUNE 23, 2017, the U.S. Food and Drug Administration (FDA) approved betrixaban (Bevyxxa) for the prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and o...
FDA Approves First CAR T-Cell Therapy for Pediatric, Young Adult Patients With ALL
The ASCO Post
ON AUGUST 30, 2017, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for pediatric and young adult patients up to 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory to initial treatment or in second or later relapse. Tisagenlecleucel...
Expert Point of View: David Maloney, MD, and Kenneth C. Anderson, MD
The ASCO Post
SIMILAR CELLULAR immunotherapies are currently being developed and tested by other National Cancer Institute–designated cancer centers, including Fred Hutchinson Cancer Research Center. David Maloney, MD, Medical Director of Cellular Immunotherapy at Fred Hutchinson and Medical Director of th...
Recent FDA Actions Include New Drug Approvals in Leukemia, Expanded Approvals in Colorectal Cancer and Graft-vs-Host Disease
The ASCO Post
The U.S. Food and Drug Administration (FDA) recently granted approval, expanded approval, and breakthrough therapy designation to numerous treatments across a range of tumor types and malignancies. New Drug Approvals Daunorubicin-Cytarabine Combination (Vyxeos): On August 3, the FDA granted regu...
FDA Actions Yield Extended Approvals of Novel Agents, Advisory Committee Votes Favorably on Two Biosimilars and Pediatric Indication for CAR T-Cell Therapy
The ASCO Post
DURING JULY, the U.S. Food and Drug Administration (FDA) and its Oncologic Drugs Advisory Committee (ODAC) made a number of approvals and recommendations on a variety of oncology products. Neratinib ON JULY 1 7, the FDA approved neratinib (Nerlynx) for the extended adjuvant treatment of adult pa...
FDA Takes Action Against 14 Companies for Selling Illegal Cancer Treatments
On April 25, the U.S. Food and Drug Administration (FDA) posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat, or cure cancer. The products are marketed and sold without FDA approval, most co...
FDA Approves Aminolevulinic Acid Hydrochloride as an Optical Imaging Agent Indicated in Gliomas
ON JUNE 6, the U.S. Food and Drug Administration (FDA) approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan), as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization [WHO] grades III or IV) for preoperative imaging, as an adjunct for the v...
FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved the use of the monoclonal antibody daratumumab -(Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide ...
FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer
On June 30, 2017, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for panitumumab (Vectibix) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colo...
FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved the use of the monoclonal antibody daratumumab (Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (...
FDA Approves Pembrolizumab for First Tissue/Site-Agnostic Indication
On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed f...
FDA Broadens Ceritinib Indication
On May 26, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to ceritinib (Zykadia), a kinase inhibitor for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. In April 2...
FDA Oncology Drug Approvals Granted Between August 2016 and May 18, 2017
The ASCO Post
Pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, received regular approval from the U.S. Food and Drug Administration (FDA) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chem...
FDA Approves Avelumab for Metastatic Merkel Cell Carcinoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio) on March 23, 2017, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. Avelumab is a pro...
FDA Approves Maintenance Niraparib for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose tumors have achieved complete or partial response to platinum-based chemotherapy. “Main...
FDA Approves Lenalidomide as Maintenance Therapy for Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
The ASCO Post
On February 22, the U.S. Food and Drug Administration (FDA) expanded the existing indication for lenalidomide (Revlimid) 10-mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant. Clinical Trial Findings The ap...
FDA Approves Ibrutinib in Relapsed/Refractory Marginal Zone Lymphoma
The ASCO Post
On January 19, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica) for the treatment of patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti–CD20-based therapy. Accelerated approval was granted for this indication based on...
FDA Establishes Oncology Center of Excellence, Names Richard Pazdur, MD, Director
The ASCO Post
On January 19, 2017, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement: Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence and appointing Richard Pazdur, MD, as its Director. This wil...
Oncology Drug Approvals in 2016
The ASCO Post
In 2016, the Office of Hematology and Oncology Products of the U.S. Food and Drug Administration (FDA) approved a number of new molecular entities, indications, and tests. The most notable were drug approvals in disease areas such as non–small cell lung cancer, myeloma, head and neck cancer, and bre...
FDA Approves Extended-Release Morphine Product Formulated With Abuse-Deterrent Properties
The ASCO Post
On January 9, the U.S. Food and Drug Administration (FDA) approved morphine sulfate extended-release tablets with abuse-deterrent properties (Arymo ER), a C-II drug for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative tre...
FDA Approves Daratumumab in Combination Therapy for Patients With Multiple Myeloma Receiving at Least One Prior Treatment
The ASCO Post
On November 21, 2016, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.1...
FDA Approves Nivolumab for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
The ASCO Post
On November 10, 2016, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. Approval was based on data from an int...
FDA Approves Pembrolizumab as First-Line Treatment for PD-L1–Positive Non–Small Cell Lung Cancer
The ASCO Post
On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) as determined by an FDA-approved test. This is the first FD...
FDA Grants Accelerated Approval to Olaratumab for Treatment of Advanced Soft-Tissue Sarcoma
The ASCO Post
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to olaratumab (Lartruvo) in combination with doxorubicin to treat adults with certain types of soft-tissue sarcoma. Olaratumab is approved for use with the FDA-approved chemotherapy drug doxorubicin for th...
FDA Approves Ofatumumab in Combination With Fludarabine and Cyclophosphamide for Relapsed CLL
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The application, which receiv...
FDA Grants Priority Review to Pembrolizumab Supplemental Biologics License Application for First-Line Treatment of Advanced NSCLC
The ASCO Post
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the first-line treatment of patients with advanced non–small cell lung cancer (...
FDA Approves Blinatumomab for Use in Pediatric Patients With Ph-Negative Relapsed or Refractory B-Cell Precursor ALL
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome (Ph)-negative relapsed or refractory B-cell precursor acute lymph...
FDA Grants Orphan Drug Designation to CD4CAR for the Treatment of Peripheral T-Cell Lymphoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for chimeric antigen receptor–engineered T cells directed against the target protein CD4 (CD4CAR) for the treatment of peripheral T-cell lymphoma. William Tse, MD, Chief of the Blood and Marrow Transplantation Divi...
FDA Approves Pembrolizumab for Metastatic Head and Neck Squamous Cell Carcinoma
The ASCO Post
On August 5, 2016, the U. S. Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or ...
FDA Approves Extended-Release Granisetron Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved an extended-release version of granisetron (Sustol) for the prevention of chemotherapy-induced nausea and vomiting, according to a news release by Heron Therapeutics, the drug’s manufacturer. Granisetron is an extended-release, injectable 5-HT...
FDA Approves First HPV Test for Use With SurePath Preservative Fluid
The ASCO Post
On July 7, 2016, the U.S. Food and Drug Administration (FDA) approved the Roche cobas HPV Test as the first test for human papillomavirus (HPV) that can be used with cervical cells obtained for a Papanicolau (Pap) test and collected in SurePath Preservative Fluid. The FDA approves HPV tests to be u...
FDA Approves Sofosbuvir/Velpatasvir for Treatment of Chronic Hepatitis C Virus Infection
The ASCO Post
The U.S. Food and Drug Administration (FDA) approved Epclusa (sofosbuvir at 400 mg/velpatasvir at 100 mg) on June 28, 2016, to treat adult patients with chronic hepatitis C virus both with and without cirrhosis. For patients with moderate to severe cirrhosis (decompensated cirrhosis), sofosbuvir/vel...
FDA Advances Precision Medicine Initiative by Issuing Draft Guidances on Next-Generation Sequencing–Based Tests
In support of the President’s Precision Medicine Initiative, on July 6, the U.S. Food and Drug Administration (FDA) issued two draft guidances. When finalized, they will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s ge...
ASCO Applauds Selection of Richard Pazdur, MD, to Lead New FDA Oncology Center of Excellence
Daniel F. Hayes, MD, ASCO President, issued the following statement on June 29, 2016: “ASCO commends FDA Commissioner Dr. Robert Califf for his selection of Dr. Richard Pazdur to lead the agency’s new Oncology Center of Excellence. In his nearly 20 years with the FDA, Dr. Pazdur has worked inn...
Richard Pazdur, MD, Named Acting Director of FDA’s Oncology Center of Excellence
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement June 29, 2016, regarding the appointment of Richard Pazdur, MD, as the Acting Director of the FDA Oncology Center of Excellence. Dr. Pazdur is currently Director of the Office of Oncology Hematolog...
FDA Approves New Diagnostic Imaging Agent to Detect Recurrent Prostate Cancer
On May 27, the U.S. Food and Drug Administration (FDA) approved fluciclovine F-18 (Axumin), a radioactive diagnostic agent for injection. Fluciclovine F-18 is indicated for positron-emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate-specific...
FDA Approves New Diagnostic Imaging Agent to Detect Rare Neuroendocrine Tumors
The U.S. Food and Drug Administration (FDA) has approved Netspot, the first kit for the preparation of Ga-68 dotatate injection, a radioactive diagnostic agent for positron-emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with somato...
FDA Approves Nivolumab for Heavily Pretreated Classical Hodgkin Lymphoma
On May 17, 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the programmed cell death protein 1 (PD‑1) inhibitor, nivolumab (Opdivo), for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cel...
FDA Grants Selumetinib Orphan Drug Designation for Adjuvant Treatment of Differentiated Thyroid Cancer
Earlier this month, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for the investigational MEK1/2 inhibitor selumetinib for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer. Selumetinib inhibits the MEK pat...
FDA Maintains Ongoing Efforts to Expedite Drug Approvals
The U.S. Food and Drug Administration (FDA) is continuing its efforts to expedite oncology-hematology drug approvals. As of May 15, 2016, FDA has approved the following agents since January of this year. Lenvatinib (Lenvima), in combination with everolimus (Afinitor), for the treatment of advance...
ODAC Advises the FDA to Wait for Phase III Results for Rociletinib in Non–Small Cell Lung Cancer
Kirsten Boyd Goldberg
The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) met April 12 to consider a New Drug Application by Clovis Oncology for rociletinib, an investigational therapy for epidermal growth factor receptor (EGFR)-mutated non–small cell lung cancer (NSCLC) in patients wi...
FDA Approves Lenvatinib in Combination With Everolimus in Advanced Renal Cell Carcinoma
On May 13, 2016, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima) in combination with everolimus (Afinitor) for the treatment of advanced renal cell carcinoma following one prior antiangiogenic therapy. Lenvatinib was first approved in 2015 for the treatment of loca...
New FDA Rule Prohibits Sale of E-Cigarettes to Anyone Under Age 18 and Requires Warning Labels
A new rule extending U.S. Food and Drug Administration (FDA) oversight to all tobacco products, including electronic cigarettes (e-cigarettes), and banning the sale of these products to anyone under the age of 181 was hailed as a major advanced by many leaders of medical and health organizations. Th...
FDA Approves Cabozantinib in Patients With Renal Cell Carcinoma Who Have Received Prior Antiangiogenic Therapy
On April 25, 2016, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for the treatment of advanced renal cell carcinoma in patients who have received prior antiangiogenic therapy. Cabozantinib is a dual tyrosine kinase inhibitor of MET and VEGFR2. The capsule for...
FDA Launches First Campaign Focused on Dangers of Smokeless Tobacco Among Rural Teens
The U.S. Food and Drug Administration (FDA) has announced it is expanding its award-winning “The Real Cost” campaign to educate rural white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time, messages on the dangers of smokeless tobacco us...
FDA Approves Defibrotide for Complication of Stem Cell Transplant
The ASCO Post
On March 30, 2016, the U.S. Food and Drug Administration (FDA) approved defibrotide sodium (Defitelio) for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction following hematopoietic s...
FDA Approves Crizotinib for ROS1-Positive Metastatic Non–Small Cell Lung Cancer
The ASCO Post
The U.S. Food and Drug Administration has approved the tyrosine kinase inhibitor crizotinib (Xalkori) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients whose tumors are ...
FDA Approves Everolimus for Neuroendocrine Tumors of GI or Lung Origin
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved everolimus (Afinitor), an mTOR inhibitor, for the treatment of adult patients with progressive, well-differentiated nonfunctional neuroendocrine tumors of gastrointestinal (GI) or lung origin with unresectable, locally advanced, or metastatic ...
FDA Approves Obinutuzumab in Follicular Lymphoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved obinutuzumab (Gazyva), an anti-CD-20 monoclonal antibody, for use in combination with bendamustine (Bendeka, Treanda) followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma who relapsed after, or are refrac...
Pembrolizumab Label Updated With New Clinical Trial Information
The ASCO Post
Late in 2015, the U. S. Food and Drug Administration (FDA) expanded the label for pembrolizumab (Keytruda), a humanized antibody, to include the initial treatment of patients with unresectable or metastatic melanoma. Previously, pembrolizumab had received accelerated approval in patients with unr...
FDA Approves Ofatumumab for Patients With Chronic Lymphocytic Leukemia in Complete or Partial Response
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra), a CD20-directed cytolytic monoclonal antibody, for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL)...
FDA Oncology New Drug/New Indication Approvals for 2015
The ASCO Post
The following new hematology/oncology agents and expanded indications were approved by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research in 2015: Alectinib (Alecensa), an ALK inhibitor, for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive ...
November Yields Record Number of FDA Approvals for New Oncology Drugs and Drug Indications
Jo Cavallo
In 2014, the U.S. Food and Drug Administration (FDA) approved 9 new drugs and biologics in the treatment of cancer and added 10 notable new indications or formulations to existing drug labels, marking a year of significant progress in improving the quality of cancer care in the United States. So far...
FDA Approves Elotuzumab in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted approval for elotuzumab (Empliciti) in combination with two other therapies to treat patients with multiple myeloma who have received one to three prior medications. “We are continuing to learn about the ways the immune system interacts with d...
Nivolumab Receives Two FDA Approvals in November
The ASCO Post
Nivolumab (Opdivo) is a monoclonal antibody that binds to the programmed cell death protein 1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and PD-L2, releasing PD-1 pathway–mediated inhibition of the immune response. Late last month, the U.S. Food and Drug Administration (FDA) a...
FDA Approves Necitumumab Combination for Metastatic Squamous NSCLC
The ASCO Post
The FDA approved necitumumab (Portrazza) in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC). Necitumumab is not indicated for treatment of nonsquamous NSCLC. Necitumumab is a recombinant human IgG1 monoclona...
FDA Approves Cobimetinib in Combination With Vemurafenib for Metastatic Melanoma
The ASCO Post
On November 10, 2015, the U.S. Food and Drug Administration (FDA) approved the MEK inhibitor cobimetinib (Cotellic) in combination with the BRAF inhibitor vemurafenib (Zelboraf) to treat metastatic or unresectable melanoma in patients whose tumors express the BRAF V600E or V600K mutation. Approval o...
Daratumumab Approved in Multiple Myeloma
The ASCO Post
The U.S. Food and Drug Administration has granted accelerated approval for daratumumab (Darzalex) to treat patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome in...
FDA Approves Trabectedin for Advanced Liposarcoma and Leiomyosarcoma
The ASCO Post
The U.S. Food and Drug Administration has approved the novel chemotherapy drug trabectedin (Yondelis) for the treatment of specific soft-tissue sarcomas—liposarcoma and leiomyosarcoma—that are unresectable or metastatic. Trabectedin is a novel marine antineoplastic alkaloid with a unique mechanism ...
FDA Approves Liposomal Irinotecan for Advanced Pancreatic Cancer
The ASCO Post
The U.S. Food and Drug Administration has approved irinotecan liposome injection (Onivyde), in combination with fluorouracil (5-FU) and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The effectiveness of liposoma...
FDA Approves Ipilimumab in Adjuvant Treatment of Stage III Melanoma
The ASCO Post
On October 28, 2015, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody ipilimumab (Yervoy) for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including ...
Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia
The ASCO Post
Pfizer recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the company’s investigational antibody-drug conjugate inotuzumab ozogamicin for acute lymphoblastic leukemia (ALL). The FDA’s decision was based on the results of the phase III ...
FDA Approves First Oncolytic Viral Therapy in the United States
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved the biologics license application for talimogene laherparepvec (Imlygic), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma rec...
FDA Approves Use of Nivolumab in Metastatic Nonsquamous Lung Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved nivolumab (Opdivo) to treat patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy. Nivolumab is a monoclonal antibody that that blocks the PD-1/PD-L1 [progr...
FDA Grants Orphan Drug Designation to Bivalent Vaccine for Neuroblastoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to MabVax Therapeutics’ vaccine for the treatment of relapsed or recurrent high-risk neuroblastoma in remission or with limited residual disease after best available treatment. The bivalent vaccine is intended to elicit ...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced NSCLC
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for pembrolizumab (Keytruda) to treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express programmed cell death-ligand 1 (PD-L1). Pemb...
FDA Approves Expanded Indication for Medical Device to Treat Newly Diagnosed Glioblastoma Multiforme
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved an expanded indication for the Optune tumor-treating fields device to treat patients with newly diagnosed glioblastoma multiforme. It is given along with the chemotherapy drug temozolomide following standard treatments that include surgery, ch...
FDA Approves New Oral Medication for the Treatment of Refractory Metastatic Colorectal Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved trifluridine/tipiracil (Lonsurf) for patients with metastatic colorectal cancer who have been previously treated with chemotherapy and biologic therapy and are no longer responding to treatment. Mechanism of Action The new oral agent is a co...
FDA Approves Rolapitant for Prevention of Chemotherapy-Induced Nausea and Vomiting
The ASCO Post
The U.S. Food and Drug Administration (FDA) approved rolapitant (Varubi) to prevent delayed-phase chemotherapy-induced nausea and vomiting. Rolapitant is approved in adults in combination with other antiemetic agents that prevent nausea and vomiting associated with initial and repeat courses of emet...
FDA Grants Regular Approval to Brentuximab Vedotin in High-Risk Classical Hodgkin Lymphoma
The ASCO Post
The U.S. Food and Drug Administration has approved brentuximab vedotin (Adcetris) as post–autologous hematopoietic stem cell transplantation consolidation treatment for patients with classical Hodgkin lymphoma at high risk of relapse or progression, Seattle Genetics has announced. The approval is b...
FDA Accepts for Priority Review the Biologics License Application for Elotuzumab for the Treatment of Relapsed Multiple Myeloma
The ASCO Post
Bristol-Myers Squibb and AbbVie recently announced that the U.S. Food and Drug Administration has accepted for priority review the Biologics License Application for elotuzumab, an investigational signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody, for the treatment...
FDA Approves Carfilzomib Combination for Patients With Relapsed Multiple Myeloma
The ASCO Post
The U.S. Food and Drug Administration (FDA) approved carfilzomib (Kyprolis) in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. In the United States, there are nearly 96,000...
FDA Grants Breakthrough Therapy Designation to Lenvatinib for Metastatic Renal Cell Carcinoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) granted lenvatinib (Lenvima) Breakthrough Therapy designation for investigational use in patients with advanced or metastatic renal cell carcinoma who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy. Lenvatinib is...
Dactinomycin Formulation Gets Orphan Drug Designation
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to NanoSmart Pharmaceuticals’ novel formulation of dactinomycin for the treatment of Ewing sarcoma, a rare type of childhood bone cancer. The designation was granted on the basis of a plausible hypothesis that the novel ...
FDA Approves Sonidegib for Locally Advanced Basal Cell Carcinoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) approved sonidegib (Odomzo) for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy or those who are not candidates for surgery or radiation therapy. The approval was based on demon...
FDA Grants Orphan Drug Designation to Antitropomyosin Drug for Neuroblastoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Novogen Limited’s chemotherapy candidate drug Anisina for neuroblastoma. Anisina is a small molecule belonging to a family of compounds called antitropomyosins. It has been designed to inhibit Tpm3.1, a structural pro...
ODAC Discussion ‘Constructive’ About Necitumumab for Squamous NSCLC
Kirsten Boyd Goldberg
The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) favored the approval of necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with locally advanced or metastatic squamous non–small cell lung cancer (NSCLC). In a...
FDA’s Pregnancy Category Labeling
Todd Palmby, PhD, and Eias Zahalka, PhD, MBA
INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA supervisory toxicologist Todd Palmby, PhD, and pharmacologist Eias Zahalka, PhD, MBA, discuss the approach taken in the Office of ...
Venetoclax Receives Breakthrough Therapy Designation in Relapsed/Refractory CLL With 17p Deletion
The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to AbbVie’s investigational agent venetoclax (ABT-199) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) in patients with 17p deletion. Venetoclax is an investigational oral B-cell lympho...
FDA Grants Fast Track Designation to Evofosfamide for Advanced Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of evofosfamide (TH-302), administered in combination with gemcitabine, for previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an investig...
FDA Accepts Supplemental Biologics License Application for Nivolumab in Patients With Previously Untreated Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted for filing and review Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted Priority R...
Cobas KRAS Mutation Test Receives FDA Approval
Roche announced that the U.S. Food and Drug Administration (FDA) has approved the cobas KRAS Mutation Test for diagnostic use. The real-time polymerase chain reaction (PCR) test is designed to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer and aid clinicians...
Building a Better Federal Oncology Workforce
The process of delivering novel treatments for patients with cancer involves a multifaceted and long-term interaction between three distinct entities: clinical researchers, who conduct the trials which test treatments; drug developers, including the pharmaceutical industry, which takes cancer drugs ...
Crizotinib Receives Breakthrough Therapy Designation for ROS1-Positive NSCLC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to crizotinib (Xalkori) for the potential treatment of patients with ROS1-positive non–small cell lung cancer (NSCLC). Crizotinib currently is FDA-approved for the treatment of patients with metastatic NSCLC who...
FDA Approves Ramucirumab for Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) today approved ramucirumab (Cyramza) for use in combination with FOLFIRI (leucovorin, fluorouracil, irinotecan) for the treatment of patients with metastatic colorectal cancer whose disease has progressed on a first-line bevacizumab (Avastin)-, oxaliplati...
FDA Grants Breakthrough Therapy Designation to Rucaparib in Advanced Ovarian Cancer With BRCA Mutations
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Clovis Oncology’s investigational agent rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated ...
FDA Grants Priority Review to Carfilzomib Supplemental New Drug Application for Relapsed Multiple Myeloma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has accepted Amgen’s supplemental New Drug Application (sNDA) for carfilzomib (Kyprolis) injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the conversion of ...
FDA Approves First Biosimilar Product Filgrastim-Sndz
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved filgrastim-sndz (Zarxio), the first biosimilar product approved in the United States. A biosimilar product is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic. The biosimilar als...
FDA Approves Nivolumab to Treat Metastatic Squamous NSCLC
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor nivolumab (Opdivo) for the treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. Nivolumab is a monoclonal antibody that binds to the P...
FDA Approves Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved Astellas’ New Drug Application for the use of isavuconazonium sulfate (Cresemba), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomyc...
Priority Review Granted for Trabectedin in Advanced Soft-Tissue Sarcoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for trabectedin to treat patients with advanced soft-tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. The NDA ...
FDA Launches Drug Shortages Mobile App
The ASCO Post
Today, the U.S. Food and Drug Administration (FDA) launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages, and discontinuations of drug products. D...
Dinutuximab Combination Approved for Pediatric High-Risk Neuroblastoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved dinutuximab (Unituxin), a monoclonal antibody targeting glycolipid GD2, as part of first-line therapy for pediatric patients with high-risk neuroblastoma. A chimeric monoclonal antibody that binds to the surface of neuroblastoma cells, dinutu...
FDA Approves Palbociclib in Combination With Letrozole for Advanced Breast Cancer
The ASCO Post
The U.S. Food and Drug Administration has granted accelerated approval to palbociclib (Ibrance) in combination with letrozole for the treatment of postmenopausal women with estrogen receptor–positive, HER2-negative metastatic breast cancer who have not yet received an endocrine-based therapy. Palbo...
FDA Grants Cobimetinib Priority Review for Use in Combination With Vemurafenib in Advanced Melanoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for Genentech’s New Drug Application (NDA) for cobimetinib in combination with vemurafenib (Zelboraf) for the treatment of people with BRAF V600 mutation–positive advanced melanoma. The FDA will make a decision on a...
FDA Grants Breakthrough Therapy Designation to MPDL3280A for Non–Small Cell Lung Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Genentech’s investigational cancer immunotherapy MPDL3280A for the treatment of PD-L1–positive non–small cell lung cancer (NSCLC) that has progressed during or after platinum-based chemotherapy (and an approp...
FDA Approves Lenvatinib for Progressive Radioiodine-Refractory Differentiated Thyroid Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted approval to lenvatinib (Lenvima) to treat patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine therapy. Lenvatinib is a tyrosine kinase inhibitor that binds to multiple sites inv...
Human Reovirus Formulation Gets Orphan Drug Designation in Ovarian and Pancreatic Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for Oncolytics Biotech’s proprietary formulation of the human reovirus (Reolysin) for the treatment of ovarian and pancreatic cancer. The reovirus’s primary mode of activity is to infect and selectively target tumors wit...
FDA Approves Panobinostat Combination for the Treatment of Multiple Myeloma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved panobinostat (Farydak) in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma. Panobinostat is the first histone deacetylase (HDAC) inhibitor approved to treat multiple myeloma. It is int...
FDA Approves Lenalidomide in Combination With Dexamethasone for Newly Diagnosed Multiple Myeloma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has expanded the existing indication for lenalidomide (Revlimid) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Lenalidomide plus dexamethasone was previously approved in June 2006 for use in multiple myeloma p...
FDA Expands Approved Use of Ibrutinib for Waldenström’s Macroglobulinemia
The ASCO Post
The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) for patients with Waldenström’s macroglobulinemia, a rare, indolent type of B-cell lymphoma. Ibrutinib is the first therapy indicated specifically for Waldenström’s macroglobulinemia and previously r...
CPX-351 Receives Fast Track Designation for Secondary Acute Myeloid Leukemia in Elderly Patients
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Celator Pharmaceuticals’ investigational agent CPX-351, a liposomal formulation of cytarabine:daunorubicin, for the treatment of elderly patients with secondary acute myeloid leukemia. The FDA established the Fast Tra...
Supplemental New Drug Application for Carfilzomib
The ASCO Post
Amgen and its subsidiary Onyx Pharmaceuticals, Inc, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least on...
FDA Approves Nivolumab for Advanced Melanoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a programmed cell death protein 1 (PD-1) inhibitor, is intended for patients who have been previou...
FDA Approves Ramucirumab Combination for Non–Small Cell Lung Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) for use in combination with docetaxel for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK mutations ...
FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to olaparib (Lynparza) for women with advanced ovarian cancer with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as detected by an FDA-approved test, who have been treated with three or...
FDA Drug Approvals 2014
The ASCO Post
Nivolumab (Opdivo), a monoclonal antibody, was approved for treatment of metastatic melanoma. Approved December 22, 2014. Olaparib (Lynparza), a poly (ADP-ribose) polymerase (PARP) inhibitor, was approved for treatment of BRCA-mutated advanced ovarian cancer. Approved December 19, 2014. Lanreot...
FDA Approves Companion Diagnostic for the Detection of BRCA1/2 Mutations in Ovarian Cancer
The ASCO Post
The recent U.S. Food and Drug Administration (FDA) of olaparib (Lynparza) occurred concurrently with that of a companion diagnostic, BRACAnalysis CDx. This genetic test is designed to detect the presence of mutations in the BRCA genes in blood samples from patients with ovarian cancer. The BRCA gene...
FDA Approves Denosumab for the Treatment of Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy
The ASCO Post
The U.S. Food and Drug Administration has approved a new indication for denosumab (Xgeva) for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Denosumab was approved and granted Orphan Drug designation by the FDA, which is reserved for drugs that are intended for th...
Ixazomib Receives Breakthrough Therapy Designation for Relapsed or Refractory Systemic Light-Chain Amyloidosis
The ASCO Post
The U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy status to Takeda Pharmaceuticals’ investigational, oral proteasome inhibitor, ixazomib (MLN9708), for the treatment of relapsed or refractory systemic light-chain amyloidosis. This is the first proteasome inhibitor and fi...
FDA Grants Breakthrough Therapy Designation to Investigational CAR T-Cell Therapy
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to JCAR015, an investigational chimeric antigen receptor therapy developed by Juno Therapeutics. The designation applies for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia and was fi...
FDA Approves Blinatumomab to Treat Rare Form of Acute Lymphoblastic Leukemia
The ASCO Post
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to blinatumomab (Blincyto) for the treatment of patients with Philadelphia chromosome–negative, relapsed or refractory precursor B-cell acute lymphoblastic leukemia (B-cell ALL). Blinatumomab is a bispecific CD19-directed...
Necuparanib Receives Fast Track Designation From the FDA for the Treatment of Metastatic Pancreatic Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of necuparanib as a first-line treatment in combination with paclitaxel and gemcitabine in patients with metastatic pancreatic cancer. Necuparanib is a novel oncology drug candidate engineered from un...
FDA Approves Ruxolitinib to Treat Patients With Polycythemia Vera
The ASCO Post
The U.S. Food and Drug Administration (FDA) approved a new use for ruxolitinib (Jakafi) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Ruxolitinib, a JAK inhibitor, is the first drug approved by the FDA for this condition. Polycythemia vera occurs when too many red...
FDA Approves Bevacizumab Plus Chemotherapy for Platinum-Resistant, Recurrent Ovarian Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for the treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The approval is...
FDA Grants Orphan Drug Designation to BGB324 for Acute Myeloid Leukemia
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to BGB324 for the treatment of acute myeloid leukemia (AML). BGB324 is a first-in-class, highly selective small-molecule inhibitor of the Axl receptor tyrosine kinase. It blocks the epithelial-mesenchymal transition (EMT...
FDA Approves Extended-Release, Single-Entity Hydrocodone Product With Abuse-Deterrent Properties
The ASCO Post
The U.S. Food and Drug Administration (FDA) today approved hydrocodone bitartrate (Hysingla ER), an extended-release opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product has...
FDA Grants Breakthrough Therapy Designation Pembrolizumab in Advanced Non–Small Cell Lung Cancer
The ASCO Post
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, pembrolizumab releases the PD-1 pathway–mediated inhibition of the immune response, incl...
FDA Approves Labeling With Abuse-Deterrent Features for Extended-Release Opioid Analgesic
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved new labeling for morphine sulfate and naltrexone hydrochloride extended-release capsules. The drug, marketed as Embeda, is an opioid analgesic used to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and ...
FDA Approves Ramucirumab in Combination With Paclitaxel for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma. Ramucirumab was approved in April 2014 as a single agent for the treatment of patien...
FDA Approves Bortezomib Injection for Previously Untreated Patients With Mantle Cell Lymphoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved bortezomib (Velcade) injection for previously untreated patients with mantle cell lymphoma. This is the first treatment in the United States to be approved for use in previously untreated patients with mantle cell lymphoma. Bortezomib was prev...
FDA Approves Netupitant and Palonosetron Combination Capsule for Chemotherapy-Induced Nausea and Vomiting
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved a combination of netupitant and palonosetron (Akynzeo) to treat nausea and vomiting in patients undergoing cancer chemotherapy. The new drug, also known as NEPA, is a fixed-combination capsule comprised of two agents: oral palonosetron, which...
Blinatumomab Receives FDA Priority Review Designation in Acute Lymphoblastic Leukemia
The ASCO Post
The U.S. Food and Drug Administration (FDA) has accepted for review Amgen’s Biologics License Application for blinatumomab for the treatment of adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). As part of the acceptance, the FDA granted ...
Lenvatinib Receives Priority Review Designation for Advanced Thyroid Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has given Priority Review designation to the New Drug Application for lenvatinib mesylate as a treatment for progressive radioactive iodine–refractory differentiated thyroid cancer. Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor with a u...
Lymphatic Mapping Agent Receives Orphan Drug Designation for Head and Neck Cancers
The ASCO Post
Navidea Biopharmaceuticals, Inc, recently announced that technetium 99m tilmanocept (Lymphoseek Injection) has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for use in sentinel lymph node detection in patients with cancer of the head and neck. The designation ...
FDA Grants Orphan Drug Designation to Bivalent Vaccine for Neuroblastoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to MabVax Therapeutics’ vaccine for the treatment of relapsed or recurrent high-risk neuroblastoma in remission or with limited residual disease after best available treatment. The bivalent vaccine is intended to elicit ...
Aldoxorubicin Receives FDA Orphan Drug Designations for Glioblastoma, Small Cell Lung Cancer, and Ovarian Cancer
The ASCO Post
The U.S. Food and Drug Administration has granted Orphan Drug Designations to aldoxorubicin in three indications: glioblastoma multiforme, small cell lung cancer, and ovarian cancer. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to albumi...
FDA Approves Pembrolizumab for Advanced Melanoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to the anti–PD-1 antibody pembrolizumab (Keytruda) for the treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Pembrolizumab is intended for use following treatment w...
Novel Immunotherapy for Ovarian Cancer Receives Fast Track Designation
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted fast track designation to the investigation of motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-...
FDA Grants Fast Tract Designation to Investigational Combination Therapy In Metastatic Pancreatic Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Halozyme Therapeutics’ program investigating pegylated recombinant human hyaluronidase (PEGPH20) in combination with gemcitabine and albumin-bound paclitaxel (nab-paclitaxel [Abraxane]) for the treatment of patients w...
Patient-Reported Outcomes in Hematology and Oncology Product Development
The ASCO Post
INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, Virginia Kwitkowski, MS, RN, ACNP-BC, and Elektra Papadopoulos, MD, MPH, discuss FDA’s current approach to the review of study endpoin...
FDA Grants Priority Review to Lanreotide Injection for Gastroenteropancreatic Neuroendocrine Tumors
The ASCO Post
The U.S. Food and Drug Administration (FDA) has accepted and granted priority review to Ipsen’s supplemental New Drug Application (sNDA) for the somatostatin analog lanreotide (Somatuline Depot) 120 mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors. The FDA designates pri...
FDA Approves First Noninvasive DNA Screening Test for Colorectal Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursor...
FDA Grants Fast Track Designation to Novel JAK2 Inhibitor for the Treatment of Myelofibrosis
The ASCO Post
The U.S. Food and Drug Administration has granted Fast Track designation to pacritinib for the treatment of intermediate- and high-risk myelofibrosis, including patients with disease-related thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are suboptimally m...
FDA Approves Bevacizumab for Aggressive and Late-Stage Cervical Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved the antiangiogenic agent bevacizumab (Avastin) for the treatment of persistent, recurrent, or metastatic cervical cancer. The new indication is approved for use in combination with paclitaxel and cisplatin or paclitaxel and topotecan. The FDA ...
FDA Approves Bortezomib Retreatment in Patients With Multiple Myeloma
The ASCO Post
The U.S. Food and Drug Administration has approved bortezomib (Velcade) for the retreatment of adult patients with multiple myeloma who had previously responded to bortezomib therapy and relapsed at least 6 months following completion of prior bortezomib treatment. The labeling update includes dosin...
Recent FDA Drug Approvals Foster Growing Treatment Armamentarium for Chronic Lymphocytic Leukemia and Rare B-Cell Lymphomas
The ASCO Post
Recent approvals announced by the U.S. Food and Drug Administration (FDA) have led to increased treatment options for managing several difficult-to-treat hematologic B-cell cancers. The newly approved drugs and/or their indications include the oral PI3K delta inhibitor idelalisib (Zydelig) for the t...
FDA Grants Bevacizumab Priority Review for Certain Types of Cervical Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy in the treatment of women with persistent, recurrent, or metastatic cervical cancer. The designation of Priority R...
FDA Grants Bevacizumab Priority Review for Recurrent Platinum-Resistant Ovarian Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer. “The majority of women with ovarian ca...
FDA Takes Steps to Help Ensure the Reliability of Certain Diagnostic Tests
The ASCO Post
The U.S. Food and Drug Administration (FDA) recently took important steps to ensure that certain tests used by health-care professionals to help diagnose and treat patients provide accurate, consistent, and reliable results. First, the FDA is issuing a final guidance on the development, review, and...
AACR Issues Statement to Applaud FDA’s Actions
The ASCO Post
In a statement released earlier this month, the American Association for Cancer Research (AACR) applauded the U.S. Food and Drug Administration (FDA) for issuing its final guidance on “In Vitro Companion Diagnostic Devices” and proposing its “Framework for Regulatory Oversight of Laboratory Develope...
FDA Commissioner Margaret A. Hamburg’s Statement on the Surgeon General’s Call to Action to Prevent Skin Cancer
Margaret A. Hamburg
Each year, thousands of Americans are diagnosed with some form of skin cancer. The Surgeon General’s Call to Action to prevent skin cancer is important especially during these hot summer months when many of us spend extra time in the sun. Over the last few years, the FDA has taken a number of impo...
FDA Grants Breakthrough Therapy Designation to Investigational Chimeric Antigen Receptor Therapy for Relapsed/Refractory ALL
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy status to CTL019, an investigational chimeric antigen receptor (CAR) therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL). The Breakthrough Therapy filing was...
Orphan Drug Designation Granted for New Agent in Hepatocellular Carcinoma
CASI Pharmaceuticals, Inc, announced that its investigational agent ENMD-2076 has received orphan drug designation from the U.S. Food & Drug Administration (FDA) for the treatment of hepatocellular carcinoma. ENMD-2076 is an orally active Aurora A/angiogenic kinase inhibitor with a unique kinase...
FDA Approves Belinostat for Relapsed or Refractory Peripheral T-Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to belinostat (Beleodaq), a histone deacetylase inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma (NHL). “This is the thir...
FDA Grants Breakthrough Therapy Designation to Blinatumomab for Acute Lymphoblastic Leukemia
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to blinatumomab for adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is an investigational bispecific T-cell engager antibody designe...
FDA Drug Safety Communication: Docetaxel May Cause Symptoms of Alcohol Intoxication
The U.S. Food and Drug Administration (FDA) has issued a drug safety communication to health-care professionals warning that docetaxel contains ethanol, which may cause patients to experience intoxication during and after treatment. FDA is revising the labels of all docetaxel drug products to warn a...
FDA Advisory Committee Votes Against Accelerated Approval for Olaparib in Ovarian Cancer
The U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 that current evidence from clinical studies does not support an accelerated approval for use of olaparib as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have t...
FDA Launches 'OpenFDA' Initiative to Ease Access to Public Health Data
The U.S. Food and Drug Administration (FDA) has launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the Agency. In alignment with the recent Presidential Executive Order on Open ...
Diagnostic Imaging Agent Approved for Use in Patients With Head and Neck Cancer
The U.S. Food and Drug Administration (FDA) recently approved a new use for technetium 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent used to help doctors determine the extent to which squamous cell carcinoma has spread in the body’s head and neck region. Earlier App...
FDA Approves Magnetic Resonance Contrast Agent for Evaluation of Breast Cancer
The U.S. Food and Drug Administration has approved a new indication for gadobutrol (Gadavist) injection for intravenous use with magnetic resonance imaging (MRI) of the breast to assess the presence and extent of malignant breast disease. The approval is based on priority review of two multicenter p...
FDA Approves Radioactive Diagnostic Imaging Agent to Help Determine the Extent of Head and Neck Cancer in the Body
The U.S. Food and Drug Administration has approved a new use for technetium 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent used to help doctors determine the extent to which squamous cell carcinoma has spread in the body’s head and neck region. In 2013, tilmanocept w...
FDA Approves Palonosetron Hydrochloride for Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
The U.S. Food and Drug Administration (FDA) has approved palonosetron hydrochloride (Aloxi) injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged 1 mont...
FDA Approves Panitumumab Plus FOLFOX for Wild-Type KRAS Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has approved panitumumab (Vectibix) for use in combination with FOLFOX (fluorouracil, leucovorin, oxaliplatin) as first-line treatment in patients with wild-type KRAS (exon 2) metastatic colorectal cancer. This approval converts the accelerated monotherap...
FDA Approves Ramucirumab for Stomach Cancer
The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) to treat patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy. Ram...
FDA Approves Ceritinib for Late-Stage Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to ceritinib (Zykadia) for patients with a metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who were previously treated with crizotinib (Xalkori). Ceritinib is an ALK tyrosine kinase i...
FDA Approves Siltuximab for Rare Castleman’s Disease
The U.S. Food and Drug Administration (FDA) has approved siltuximab (Sylvant injection) for the treatment of patients with multicentric Castleman’s disease who are human immunodeficiency virus (HIV)-negative and human herpes virus-8 (HHV-8)-negative. Multicentric Castleman’s disease is a rare disor...
FDA Approves First HPV Test for Primary Cervical Cancer Screening
The U.S. Food and Drug Administration (FDA) approved the first human papillomavirus (HPV) DNA test that can be used as a primary cervical cancer screening test for women aged 25 years and older. The test also can provide information about the patient’s risk for developing cervical cancer in the futu...
FDA Proposes to Extend Its Tobacco Authority to Additional Tobacco Products, Including E-Cigarettes
On April 24, 2014, as part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration (FDA) proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products. Products...
FDA Approves Mercaptopurine Oral Suspension for Acute Lymphoblastic Leukemia
On April 28, 2014, the U.S. Food and Drug Administration approved a 20 mg/mL oral suspension of mercaptopurine (Purixan) indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Successive clinical trials have demonstrated that mercaptopurine ...
Supplemental New Drug Application Submitted for Ibrutinib in CLL
Pharmacyclics, Inc, and Janssen Biotech, Inc, have announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA), based on data from the randomized, multicenter, open-label phase III RESONATE study, a head-to-head comparison of single-agent ibrutinib ...
Volasertib Granted Orphan Drug Designation for Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to volasertib for acute myeloid leukemia. Volasertib is currently being evaluated in a phase III clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for intens...
Cancer Chemotherapy Use During Pregnancy
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, National Toxicology Program scientists Kembra L. Howdeshell, PhD, and Michael D. Shelby, PhD, discuss a recently completed monograph that reviews the published data on pr...
FDA Discourages Use of Laparoscopic Power Morcellation for Removal of Uterus or Uterine Fibroids
In a safety communication notice issued recently, the U.S. Food and Drug Administration (FDA) discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it po...
FDA Grants Orphan Drug Designation for Anti-CD19 T-Cell Cancer Immunotherapy Product
Kite Pharma, Inc, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company’s lead investigational therapy, an autologous engineered T-cell product that targets CD19 expression on B-cell malignancies, for the trea...
FDA Approves Ofatumumab for Previously Untreated Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra) injection in combination with chlorambucil (Leukeran) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. The approva...
Ethiodized Oil Approved for Imaging of Hepatocellular Carcinoma Tumors
The U.S. Food and Drug Administration has approved ethiodized oil injection (Lipiodol) for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma. The agent received orphan drug designation for management of patients with known hepatocellular carcinoma ...
The FDA’s Bad Ad Program
The ASCO Post
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, Robert Dean, MBA, Director, and Michael Sauers, Deputy Director, of Division II in the FDA’s Office of Prescription Drug Promotion discuss the FDA’s Bad Ad program. The ...
Omacetaxine Mepesuccinate Receives Full FDA Approval for CML
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted full approval to omacetaxine mepesuccinate (Synribo) for injection. The full approval was based on the final analysis of two phase II trials that evaluated the efficacy and tolerability data of omacetaxine. The agent received an accelerated app...
FDA Grants Orphan Drug Status to Pracinostat for the Treatment of Acute Myeloid Leukemia
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the investigational drug pracinostat for the treatment of acute myeloid leukemia (AML). The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective t...
FDA Orders Cessation of Sale, Distribution of Four Tobacco Products
The ASCO Post
FDA has issued orders to stop the further sale and distribution of four tobacco products currently on the market. The action marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act to order a manufacturer of currently available tobacco products...
FDA Approves Ibrutinib for the Treatment of Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) has expanded the approved use of ibrutinib (Imbruvica) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy. Ibrutinib, an oral Bruton’s tyrosine kinase inhibitor, was previously granted acce...
FDA Accepts New Drug Application for Idelalisib in Refractory Indolent Non-Hodgkin Lymphoma
The ASCO Post
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for idelalisib, a targeted, oral inhibitor of PI3K-delta, for the treatment of refractory indolent non-Hodgkin lymphoma (NHL). The FDA has granted a standard review for the NDA, with a target review date of Septe...
FDA Approves CliniMACS CD34 Reagent System for the Prevention of Graft-vs-Host Disease in AML
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved the Miltenyi Biotec’s CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-vs-host disease in patients with acute myeloid leukemia (AML) in first complete remission undergoing allogeneic stem cell transplantat...
Dabrafenib Receives FDA Breakthrough Therapy Designation for BRAF-Mutated NSCLC
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) for the treatment of patients with metastatic BRAF V600E mutation–positive non–small cell lung cancer (NSCLC) who have received at least one prior line of platinum-containing chemothera...
FDA Approves Combination Therapy for Unresectable or Metastatic Melanoma With BRAF V600E/K Mutations
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved trametinib (Mekinist) for use in combination with dabrafenib (Tafinlar) for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved tes...
Health IT Safety Guide
The ASCO Post
A new set of guides and interactive tools to help health-care providers more safely use electronic health information technology products, such as electronic health records (EHRs), are now available at www.HealthIT.gov. The Office of the National Coordinator for Health Information Technology (ONC) ...
Philips Receives FDA Clearance for Spectral Breast Density Measurement Application
The ASCO Post
Royal Philips has announced that that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Spectral Breast Density Management Application for its MicroDose SI full-field digital mammography system. The application is the first spectral breast density measurement ...
Molecularly Targeted Therapy for Lung Cancer
The ASCO Post
INSIDE THE BLACK BOX is an occasional column offering insight into the FDA and its policies and procedures. This installment addresses a changing paradigm in the treatment of lung cancer, exemplified by concurrent approval of a companion diagnostic with each of several new targeted agents or new dru...
FDA Approves Sorafenib to Treat Late-Stage Differentiated Thyroid Cancer
The ASCO Post
The U.S. Food and Drug Administration recently expanded the approved uses of sorafenib (Nexavar) to treat late-stage differentiated thyroid cancer. The new indication is for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to radioactiv...
FDA Grants Regular Approval to Crizotinib for ALK-Positive NSCLC
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted regular approval for crizotinib (Xalkori) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The approval was based o...
FDA Approves Ibrutinib for Mantle Cell Lymphoma
The ASCO Post
The U.S. Food and Drug Administration has approved ibrutinib (Imbruvica) to treat patients with mantle cell lymphoma, a rare and aggressive form of non-Hodgkin lymphoma representing about 6% of all non-Hodgkin lymphoma cases in the United States. By the time mantle cell lymphoma is diagnosed, it usu...
New Medical Device Treats Urinary Symptoms Related to Benign Prostatic Hyperplasia
The ASCO Post
The U.S. Food and Drug Administration has authorized the marketing of the UroLift system, a permanent implant to relieve low or blocked urine flow in men age 50 and older with benign prostatic hyperplasia. As men age, the prostate can become enlarged, also known as benign prostatic hyperplasia. Whe...
FDA Grants Ofatumumab Breakthrough Therapy Designation for Previously Untreated CLL
The ASCO Post
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ofatumumab (Arzerra) in combination with chlorambucil (Leukeran) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment and are inappropriate for fludarab...
FDA Approves First Extended-Release, Single-Entity Hydrocodone Product
The ASCO Post
The U.S. Food and Drug Administration (FDA) today approved hydrocodone bitartrate extended-release capsules (Zohydro ER) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. The drug, a Schedule ...
Sale of Ponatinib Suspended Due to Risk of Life-Threatening Blood Clots
The ASCO Post
The U.S. Food and Drug Administration (FDA) has asked the manufacturer of the tyrosine kinase inhibitor ponatinib (Iclusig) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Ariad Pharmaceuticals has agreed to suspen...
FDA Grants Priority Review to Ramucirumab as a Potential Single-Agent Treatment for Advanced Gastric Cancer
The ASCO Post
The FDA has assigned Priority Review to the regulatory submission for ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy. Ramucirumab is a human monoclonal antibody that specifically blocks the vascular endothelial growth fac...
Neoadjuvant Treatment of Early Breast Cancer
The ASCO Post
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this first installment, FDA Clinical Reviewers Laleh Amiri-Kordestani, MD, and Suparna Wedam, MD, discuss FDA’s recent approval of pertuzumab (Perjeta) for the neoadjuvant treatment of HER...
FDA Announces Strategic Plan to Prevent Drug Shortages
The ASCO Post
The U.S. Food and Drug Administration (FDA) is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages. The FDA has released a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the age...
FDA Approves Transducer Array Layout System for Use in Patients With Recurrent Glioblastoma Multiforme
The ASCO Post
Novocure recently announced that it has received FDA approval for its NovoTAL (Transducer Array Layout) System through a Premarket Approval supplement. The NovoTAL System allows certified physicians to use the individual magnetic resonance imaging data of recurrent glioblastoma multiforme patients t...
FDA Hears Proposals on Codevelopment of Companion Diagnostics for Breakthrough Therapies
Caroline McNeil
A companion diagnostic developed for use with a drug that has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) should automatically be eligible for priority review, according to an expert panel that presented this proposal and four others to the FDA in early...
FDA Approves Obinutuzumab for Chronic Lymphocytic Leukemia
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved obinutuzumab (Gazyva) for use in combination with chlorambucil (Leukeran) to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Obinutuzumab is the first drug with Breakthrough Therapy designation to receive FDA appr...
FDA Grants Volasertib Breakthrough Therapy Designation in AML
The ASCO Post
Boehringer Ingelheim Pharmaceuticals, Inc, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), which being evaluated for the treatment of patients aged 65 or older with prev...
FDA Announces Class-Wide Safety Labeling Changes for Long-Acting Opioid Analgesics to Combat Abuse
The ASCO Post
The U.S. Food and Drug Administration (FDA) announced class-wide safety labeling changes and new postmarketing study requirements for all extended-release and long-acting opioid analgesics intended to treat pain. “The FDA is invoking its authority to require safety labeling changes and postmarket s...
A Look Ahead: How the FDA Is Adapting in the Era of Precision Medicine
Dubbed “Cancer Czar” by the media, Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Office of Hematology and Oncology Products, said he has the “best job in oncology, with a unique vantage point in cancer drug development.” An oncologist for more than 30 years—including 14...
FDA Approves First Generic Capecitabine to Treat Colorectal and Breast Cancers
The ASCO Post
The U.S. Food and Drug Administration (FDA) has approved the first generic version of capecitabine (Xeloda), an oral chemotherapy agent used in the treatment of metastatic colorectal cancer and breast cancers. Teva Pharmaceuticals USA has gained FDA approval to market generic capecitabine in 150 and...
FDA Approves Nab-Paclitaxel for Late-Stage Pancreatic Cancer
The ASCO Post
The U.S. Food and Drug Administration (FDA) has expanded the approved uses of paclitaxel protein-bound particles for injectable suspension, albumin-bound (nab-paclitaxel, Abraxane) to treat patients with late-stage pancreatic cancer. “Patients with pancreatic cancer are often diagnosed after the ca...
FDA Grants Breakthrough Therapy Status to Entinostat for Advanced Breast Cancer
The ASCO Post
Syndax Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has designated entinostat as a Breakthrough Therapy for the treatment of locally recurrent or metastatic estrogen receptor (ER)-positive breast cancer when added to exemestane in postmenopausal women whose disease ...
FDA Approves Neoadjuvant Pertuzumab for Early-Stage Breast Cancer
The ASCO Post
On September 30, 2013, the FDA granted accelerated approval to pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and docetaxel for patients with early-stage breast cancer in the neoadjuvant setting. Pertuzumab is the first FDA-approved drug for the neoadjuvant treatment of breast canc...
FDA Approves Mechlorethamine Gel for Cutaneous T-Cell Lymphoma
The ASCO Post
Ceptaris Therapeutics, Inc, recently announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for the orphan drug mechlorethamine gel (Valchlor) for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have ...
Sorafenib Granted Priority Review for Differentiated Thyroid Cancer
The ASCO Post
Bayer HealthCare and Onyx Pharmaceuticals recently announced that the FDA has granted priority review designation to the supplemental new drug application of sorafenib (Nexavar) tablets for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer. ...
FDA Approves First Rapid Diagnostic Test to Detect Both HIV-1 Antigen and HIV-1/2 Antibodies
The ASCO Post
The U.S. Food and Drug Administration (FDA) approved the first rapid human immunodeficiency virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as ...
FDA Invites Public Input on Menthol in Cigarettes
The ASCO Post
The U.S. Food and Drug Administration (FDA) has issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes. Despite decades of work to reduce tobacco use in the United States, it continues to be the l...
FDA Issues Warning on Rare but Serious Skin Reactions with Acetaminophen
The ASCO Post
The FDA recently issued a warning that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, can be fatal. Serious Adverse Reactions FD...
New Drug Application Submitted for Ibrutinib in the Treatment of Two B-cell Malignancies
Pharmacyclics, Inc, recently announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton’s tyrosine kinase inhibitor ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) an...
Roche Files for Cervical Cancer Primary Screening Indication for cobas HPV Test
Roche recently announced it has submitted a Premarket Approval (PMA) supplement to the FDA seeking the addition of a cervical cancer primary screening indication for the cobas HPV Test. Approval of the expanded indication would mean the cobas HPV Test could be used as the first-line test rather than...
FDA Grants Priority Review to Obinutuzumab in CLL and Pertuzumab in Neoadjuvant Therapy for HER2-positive Early-stage Breast Cancer
Two drugs were recently given Priority Review designation by FDA. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia, based on final stage 1 data from the pivotal CLL11 trial. The FDA confirmed the action date is December 20, 2013. FDA also granted Pri...
FDA Announces Decisions on New Tobacco Products
For the first time since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence pathway. Un...
FDA Approves Afatinib for Late-stage Lung Cancer
On July 12, 2013, the FDA approved the tyrosine kinase inhibitor afatinib (Gilotrif) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as...
Investigational New Drug Application Filed for CFI-400945
Investigators from Princess Margaret Cancer Centre in Toronto and the University of California, Los Angeles, have submitted an Investigational New Drug (IND) application for CFI-400945, a novel drug candidate targeting the enzyme PLK4, which plays a crucial role in cell division. The news was annou...
FDA Approves Denosumab to Treat Giant Cell Tumor of the Bone
The U.S. Food and Drug Administration (FDA) has expanded the approved use of denosumab (Xgeva) to treat adults and some adolescents with giant cell tumor of the bone, a rare and usually noncancerous tumor. Denosumab, which was granted orphan product designation, was reviewed under the FDA’s priority...
Newly Approved Drugs and Indications
FDA has approved the following new drugs and/or indications in 2013: Denosumab (Xgeva subcutaneous injection) for giant cell tumor of bone. Lenalidomide (Revlimid capsules) for relapsed/refractory mantle cell lymphoma FDA approved. Trametinib (Mekinist tablets) for unresectable or metastatic me...
FDA Approves New Silicone Gel-filled Breast Implant
The FDA recently approved the MemoryShape Breast Implant for breast augmentation in women at least 22 years old and for breast reconstruction in women of any age. The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC. The FDA’s approval is based on 6 years of data from 955 women ...
FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer
The U.S. Food and Drug Administration (FDA) recently approved two new drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with advanced or unresectable melanoma. Dabrafenib, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutat...
SGX942 Gets Fast Track Status for Treatment of Oral Mucositis
The FDA has granted fast track designation to the SGX942 development program for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in patients with head and neck cancer. SGX942 is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability...
Orphan Drug Status Granted for Novel Targeted Therapy to Treat Rare Hematologic Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Stemline Therapeutics’ SL-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive hematologic malignancy for which there is no effective treatment. SL-401 also has Orphan Drug stat...
FDA Approves Lenalidomide for Relapsed/Refractory Mantle Cell Lymphoma
The U.S. Food and Drug Administration has approved lenalidomide (Revlimid) for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (Velcade). Clinical Trial The approval was based on the results of...
FDA Clears Multicenter Trial of Treatment for Hair Loss Related to Chemotherapy
The FDA has approved initiation of a multicenter trial of the DigniCap System, a scalp-cooling device for chemotherapy-related hair loss. The trial is the second and final phase of study for the DigniCap System. A pilot study previously conducted by researchers at the University of California San Fr...
FDA Approves Expanded Use for Erlotinib, Companion Diagnostic to Detect Genetic Mutations in NSCLC
The FDA has approved erlotinib (Tarceva) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This indication for erlotinib was approved concu...
Radium-223 Dichloride Approved for Patients with Castration-resistant Prostate Cancer
On May 15, 2013, the U.S. Food and Drug Administration approved radium Ra 223 dichloride (Xofigo) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Radium-223 dichloride is an alpha-particle–emitting radio...
Peregrine Pharmaceuticals Reaches Agreement with FDA on Phase III Trial Design for Bavituximab in NSCLC
Peregrine Pharmaceuticals recently announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a phase III registration trial design of the company’s lead clinical immunotherapeutic candidate bavituximab in second-line non–small cell lung cancer (NSCLC). The trial des...
Ibrutinib Receives Third Breakthrough Therapy Designation from the FDA
Pharmacyclics, Inc, announced that the FDA has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma with deletion of the short arm of chro...
Breakthrough Therapy Designation for Lambrolizumab for the Treatment of Advanced Melanoma
Merck has announced that the U.S. Food and Drug Administration (FDA) has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting the programmed death receptor (PD-1) that is...
Novel Cancer Immunotherapy Set to Enter Clinical Trials
PDS Biotechnology Corporation has announced that its Investigational New Drug application for the novel cancer immunotherapy agent PDS0101 has been granted by the FDA, allowing the agent to be evaluated in human patients. PDS0101 is based on the company’s Versamune nanotechnology vaccine platform. ...
FDA Approves Antiemetic Drug for New Line of Prefilled Generic Injectables
BD Rx Inc, announced that the FDA has approved metoclopramide hydrochloride, an injectable antiemetic, as the second drug to be offered in the recently launched BD Simplist line of ready-to-administer prefilled generic injectables. BD Simplist prefilled injectables are designed to help improve pati...
Daratumumab Receives Breakthrough Therapy Designation in Multiple Myeloma
FDA has granted daratumumab breakthrough therapy designation for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and immunom...
New Labeling for Reformulated OxyContin to Curb Abuse
The U.S. Food and Drug Administration has approved updated labeling for the reformulated painkiller OxyContin (controlled-release oxycodone hydrochloride). The new labeling will indicate that the drug has physical and chemical properties that make injection or snorting challenging. This new measure ...
FDA Warns about Potential Medication Errors
The FDA recently alerted health-care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine, also known as T-DM1 during preapproval clinical trials) in some medication-related electronic systems poses a risk of mix-up with Hercep...
Elekta Receives FDA 510(k) Clearance Following Launch of New Versa HD Radiation Therapy System
Elekta recently received 510(k) clearance from the FDA, allowing the company to begin shipping and installation of all components of the Versa HD system within the United States. The Versa HD radiation system, featuring high-precision beam shaping and tumor targeting, is capable of delivering radiat...
FDA Approves Assay That May Help Detect the Progression of Testicular Cancer
Abbott announced that the ARCHITECT AFP assay, which may help doctors detect the progression of testicular cancer as well as serious birth defects, has received FDA approval. The ARCHITECT AFP assay is a chemiluminescent microparticle immunoassay for the quantitative determination of alpha-fetoprot...
Errata
The ASCO Post
In the March 1 issue of The ASCO Post, the article on page 2, “Outcomes Comparable for Panitumumab and Bevacizumab in Metastatic Colorectal Cancer,” contained an inaccuracy about the FDA-approved indications of bevacizumab (Avastin) in colorectal cancer. Specifically, the article noted that bevacizu...
FDA Approves New Radioactive Diagnostic Imaging Agent to Help Locate Lymph Nodes in Patients with Certain Cancers
The ASCO Post
The FDA has approved technetium Tc 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. Tilmanocept is an imaging drug that hel...
Philips Receives FDA 510(k) Clearance for MicroDose SI Mammography System
The ASCO Post
Royal Philips Electronics recently announced that it has received 510(k) clearance from the FDA for its MicroDose SI system, a full-field digital mammography system that has the capability to enable future single-shot spectral imaging applications. High Breast Density High breast density is a know...
T-DM1 for HER2-positive Metastatic Breast Cancer Receives FDA Approval
The ASCO Post
The FDA approved the antibodydrug conjugate ado-trastuzumab emtansine (Kadcyla), referred to as T-DM1 during clinical research, for patients with HER2-positive, metastatic breast cancer who were previously treated with trastuzumab (Herceptin) and taxane chemotherapy. Ado-trastuzumab emtansine was r...
Ibrutinib Receives Two Oncology Breakthrough Therapy Designations from FDA
The ASCO Post
Janssen Research & Development, LLC, and Pharmacyclics, LLC, announced that the FDA has granted Breakthrough Therapy Designations for the investigational oral agent ibrutinib as a monotherapy for two B-cell malignancies: in patients with relapsed or refractory mantle cell lymphoma who have recei...
Apogenix Receives FDA Orphan Drug Designation for APG101 to Treat Myelodysplastic Syndromes and Initiates Clinical Phase I Study
The ASCO Post
Apogenix GmbH, a biopharmaceutical company developing novel protein therapeutics for the treatment of cancer and inflammatory diseases, announced that its lead compound, APG101 (Apocept), has been granted orphan drug designation from the FDA for the treatment of myelodysplastic syndromes (MDS). Dr...
FDA Approves Regorafenib for Advanced Gastrointestinal Stromal Tumors
The ASCO Post
The FDA has expanded the approved use of regorafenib (Stivarga) to treat patients with metastatic or unresectable gastrointestinal stromal tumors (GIST) that no longer respond to treatment with imatinib (Gleevec) or sunitinib (Sutent). Regorafenib, a multikinase inhibitor, blocks several enzymes tha...
FDA Approves Pomalidomide for Advanced Multiple Myeloma
The FDA approved pomalidomide (Pomalyst) an oral immunomodulatory agent, to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Pomalidomide is intended for patients who have received at least two prior therapies, including lenalidomide (Revlim...
Imatinib Receives New Indication for Children with Acute Lymphoblastic Leukemia
The FDA approved a new use of imatinib (Gleevec) to treat children newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated. Childre...
Bevacizumab Approved as Combination Therapy for Metastatic Colorectal Cancer after Progression on First-line Bevacizumab Therapy
The ASCO Post
On January 23, 2013, the FDA approved bevacizumab (Avastin) for use in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for the treatment of patients with metastatic colorectal cancer whose disease has progressed on a first-line bevacizumab-containing r...
Dune Medical Devices Receives FDA Approval for the MarginProbe System
The ASCO Post
Dune Medical Devices, Inc, announced that the FDA has granted Premarket Approval to the MarginProbe System, the company’s breakthrough intraoperative tissue assessment tool for early-stage breast cancer surgery. The technology significantly improves surgeons’ ability to intraoperatively identify “ca...
Ezatiostat Gets Orphan Designation for Treatment of Myelodysplastic Syndrome
The ASCO Post
Telik, Inc, announced that its product candidate, ezatiostat hydrochloride (Telintra), has been granted orphan drug designation by the FDA for the treatment of myelodysplastic syndromes (MDS). Ezatiostat is an investigational agent in development for the treatment of MDS and idiopathic chronic neut...
FDA Approves Ponatinib to Treat CML and Philadelphia Chromosome–positive ALL
The ASCO Post
In December, the FDA granted accelerated approval to ponatinib (Iclusig) for the treatment of adult patients with chronic-, accelerated-, or blast-phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome–positive acute...
Faster Rituximab Infusion for Previously Untreated Follicular Non-Hodgkin and Diffuse Large B-cell Lymphomas
Matthew Stenger
On October 19, 2012, FDA approved a 90-minute infusion for rituximab (Rituxan) starting at cycle 2 for patients with previously untreated follicular non-Hodgkin or diffuse large B-cell lymphoma who do not experience a grade 3 or 4 infusion-related reaction during cycle 1.1 Patients with clinically s...
New Drug Application Submitted for Radium-223 for the Treatment of Castration-resistant Prostate Cancer with Bone Metastases
The ASCO Post
Bayer HealthCare announced that the company has submitted a New Drug Application to the FDA seeking approval for radium Ra 223 dichloride (radium-223), an investigational compound for the treatment of patients with castration-resistant prostate cancer with bone metastases. “If approved, radium-223 ...
Elekta Receives FDA 510(k) Clearance for Clarity 4D Monitoring
The ASCO Post
Elekta has received 510(k) clearance from the FDA for its Clarity 4D Monitoring software, enabling U.S. medical centers to implement a new way of reducing the uncertainty caused by prostate motion during radiation treatment. Physicians will be able to monitor the motion of the prostate and surroundi...
FDA Expands Abiraterone’s Use for Late-stage Prostate Cancer
The ASCO Post
In December, the FDA approved an expanded indication for abiraterone acetate (Zytiga) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. Trial Design The approval was based on a trial randomly assigning patients with metastatic castra...
Cabozantinib Approved for Treatment of Progressive Metastatic Medullary Thyroid Cancer
The ASCO Post
The FDA recently approved cabozantinib (Cometriq), for the treatment of patients with progressive metastatic medullary thyroid cancer. Cabozantinib is a small molecule that inhibits the activity of multiple tyrosine kinases, including RET, MET, and VEGF receptor 2. The approval was based on the de...
FDA Grants Fast Track Designation to Etirinotecan Pegol for the Treatment of Metastatic Breast Cancer
The ASCO Post
Nektar Therapeutics announced that the FDA has designated etirinotecan pegol (NKTR-102) as a Fast Track development program for the treatment of patients with locally recurrent or metastatic breast cancer progressing after treatment with an anthracycline, a taxane, and capecitabine (ATC). Etirinote...
Surefire Medical Receives FDA Clearance for Angiographic Catheters
The ASCO Post
Surefire Medical, Inc, announced that the company has received 510(k) FDA clearance to market its line of Surefire Angiographic Catheters. Surefire Medical will launch these products in the United States later this year. Surefire’s Angiographic Catheter line is designed to provide interventional r...
Supplemental New Drug Application Submitted for Erlotinib as a First-line Therapy in Genetically Distinct NSCLC
The ASCO Post
Astellas Pharma US, Inc, announced it has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for erlotinib (Tarceva) tablets for first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth fa...
IMA901 Granted Orphan Drug Designation by FDA
The ASCO Post
immatics biotechnologies GmbH announced that the cancer vaccine IMA901 has been granted orphan drug designation from the FDA for the treatment of renal cell carcinoma (RCC) in HLA-A*02 positive patients. The FDA grants orphan drug designation to novel drugs aimed at treating rare diseases or conditi...
2012 In Review: Oncology Drugs/Indications Newly Approved by FDA
The ASCO Post
At press time, the FDA had granted approval for the following new agents and indications for cancer treatment in 2012. Cabozantinib (Cometriq) for the treatment of progressive metastatic medullary thyroid cancer. Cabozantinib is a small molecule that inhibits the activity of multiple tyrosine kinas...
FDA Approves Omacetaxine for Chronic Myeloid Leukemia
The ASCO Post
The FDA has approved omacetaxine mepesuccinate (Synribo) to treat adults with chronic myelogenous leukemia (CML) whose cancer has progressed after treatment with at least two tyrosine kinase inhibitors. Omacetaxine is injected subcutaneously twice daily for 14 consecutive days over a 28-day cycle u...
New Drug Application for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma
The ASCO Post
AVEO Oncology and Astellas Pharma, Inc, recently announced that AVEO has submitted a New Drug Application (NDA) to the FDA for tivozanib, in patients with advanced renal cell carcinoma (RCC). Tivozanib is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (...
FDA Approves Noninvasive Radiation Therapy to Treat Pain from Bone Metastases
The ASCO Post
InSightec Ltd announced that the FDA has approved ExAblate MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. This is the second FDA approval for ExAblate since it was approved in 2004 as ...
FDA Approves New Use of Pemetrexed in the Maintenance Setting for NSCLC
The ASCO Post
The FDA has expanded labeling to include the results of an additional trial evaluating the safety and efficacy of pemetrexed (Alimta) for the initial treatment of patients with locally advanced or metastatic, nonsquamous, non–small cell lung cancer (NSCLC) followed by pemetrexed maintenance in patie...
Rituximab Infusion Approved for NHL
The ASCO Post
The FDA recently approved a 90-minute infusion for rituximab (Rituxan) starting at cycle 2 for patients with non-Hodgkin lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during cycle 1. Patients with clinically significant cardiovascular disease and high circul...
CyberKnife M6 Series Gets FDA 510(k) Clearance
The ASCO Post
Accuray Incorporated has announced that the company received 510(k) clearance from the FDA for its new CyberKnife M6 Series. The CyberKnife M6 Series features expanded clinical capabilities and reduced treatment times. The new CyberKnife M6 FIM and FM Systems, featuring the InCise Multileaf Collimat...
Nab-paclitaxel Approved in First-line Metastatic NSCLC
The ASCO Post
The FDA has approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (nab-paclitaxel, Abraxane) for use in combination with carboplatin for the initial treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who are not candidates for ...
Regorafenib Approved for Advanced Colorectal Cancer
The ASCO Post
The FDA recently approved regorafenib (Stivarga) to treat patients with metastatic colorectal cancer that has progressed after treatment. Regorafenib is a multikinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA’s priority review program that...
New Drug Application Submitted for Regorafenib to Treat GIST
The ASCO Post
Bayer HealthCare and Onyx Pharmaceuticals recently announced that Bayer HealthCare has submitted a New Drug Application (NDA) to the FDA for the oral multikinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease...
FDA Approves New Treatment for Severe Neutropenia
The ASCO Post
The FDA recently approved Sicor Biotech’s tbo-filgrastim (Neutroval) to reduce the time certain patients receiving chemotherapy experience severe neutropenia. The new drug is a short-acting recombinant granulocyte colony-stimulating factor (G-CSF) agent. It is marketed as Tevagrastim in Europe, whe...
FDA Approves First Ultrasound Imaging System for Dense Breast Tissue
The ASCO Post
The FDA approved somo-v Automated Breast Ultrasound System (ABUS), the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer. The National Cancer Institute estimates that about 40%...
FDA Approves Production of Imaging Agent to Detect Prostate Cancer
The ASCO Post
The FDA approved the production and use of Choline C 11 Injection, a positron-emission tomography (PET) imaging agent used to help detect recurrent prostate cancer. Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue...
Paclitaxel Poliglumex Gets Orphan Drug Designation for Glioblastoma Multiforme
The ASCO Post
Cell Therapeutics, Inc, recently announced that paclitaxel poliglumex (OPAXIO) has been granted orphan drug designation by the FDA for the treatment of glioblastoma multiforme. Orphan designation was granted based on preliminary activity seen from phase II results of paclitaxel poliglumex when added...
FDA Approves New Orphan Drug for Chronic Myelogenous Leukemia
The ASCO Post
The FDA has approved bosutinib (Bosulif) to treat chronic myelogenous leukemia (CML). The drug is intended for patients with chronic, accelerated, or blast phase Philadelphia chromosome–positive CML who are resistant to or who cannot tolerate other therapies, including imatinib (Gleevec). The safet...
First Drug for Children with Rare Brain Tumor Approved
The ASCO Post
The FDA approved a new pediatric dosage form of everolimus (Afinitor Disperz) to treat the rare brain tumor called subependymal giant cell astrocytoma (SEGA). This is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor. Afinitor Disperz is recommended ...
FDA Issues New Safety Alert on Reumofan Plus and Reumofan Plus Premium
The ASCO Post
In August 21, the FDA issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain potent...
NDA for Chemosaturation System to Treat Melanoma in the Liver
The ASCO Post
Delcath Systems, Inc, announced that it has submitted a New Drug Application (NDA) to the FDA, seeking approval for its chemosaturation system (CHEMOSAT) for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The system is designed to ad...
FDA Grants Priority Review to Supplemental New Drug Application for Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer
The ASCO Post
Janssen Research & Development, LLC, announced that the FDA has granted Priority Review to the supplemental New Drug Application (sNDA) for abiraterone acetate (Zytiga) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer ...
FDA Approves New Drug for Late-stage Prostate Cancer
The ASCO Post
The FDA has approved enzalutamide (Xtandi) to treat men with metastatic castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for patients with prostate cancer previously treated with docetaxel, enzalutamide was rev...
Liposomal Vincristine Approved in Acute Lymphoblastic Leukemia
The ASCO Post
The FDA has approved vincristine sulfate liposome injection (Marqibo) to treat adults with Philadelphia chromosome–negative acute lymphoblastic leukemia (ALL). Administered once a week, liposomal vincristine is approved for patients whose leukemia has relapsed two or more times, or whose leukemia ha...
FDA Approves Ziv-aflibercept for Metastatic Colorectal Cancer
The ASCO Post
The FDA has approved ziv-aflibercept (Zaltrap) for use in combination with a FOLFIRI (leucovorin, fluorouracil, irinotecan) chemotherapy regimen to treat adults with colorectal cancer. Ziv-aflibercept is an angiogenesis inhibitor that inhibits the blood supply to tumors. It is intended for patients ...
Biokine Therapeutics Awarded FDA Orphan Drug Designation for Mobilization of Stem Cells in Patients with Cancer
The ASCO Post
Biokine Therapeutics Ltd announced that it has received Orphan Drug designation from the FDA for BKT140, a highly selective chemokine receptor antagonist that induces mobilization of hematopoietic stem cells from bone marrow into peripheral blood for collection and subsequent transplantation in pati...
FDA Approves Colon-cleansing Drug for Prep Prior to Colonoscopy
The ASCO Post
The FDA has approved sodium picosulfate, magnesium oxide, and citric acid (Prepopik) to help cleanse the colon in adults preparing for colonoscopy, Ferring Pharmaceuticals announced. The new solution is a low-volume, dual-acting stimulant and osmotic laxative. The FDA approval is based on data from...
FDA Grants Accelerated Approval to Carfilzomib for Multiple Myeloma
The ASCO Post
Onyx Pharmaceuticals announced that the FDA has granted accelerated approval to carfilzomib (Kyprolis) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including treatment with bortezomib (Velcade) and an immunomodulatory therapy, and have demonstra...
Everolimus Approved for Advanced Breast Cancer
The ASCO Post
The FDA has approved everolimus tablets (Afinitor) for use in combination with exemestane to treat postmenopausal women with advanced hormone receptor–positive, HER2-negative breast cancer after failure of treatment with letrozole or anastrozole. The approval was based on a randomized, double-blind...
Enzalutamide Gets Priority Review for Castrate-resistant Prostate Cancer
The ASCO Post
Medivation, Inc, and Astellas Pharma, Inc, announced that the FDA has accepted for filing the New Drug Application (NDA) for enzalutamide (formerly MDV3100) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy and granted P...
FDA Approves Cetuximab plus FOLFIRI/Therascreen in Colorectal Cancer
The FDA has granted approval to cetuximab (Erbitux) for use in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment of patients with KRAS mutation–negative (wild-type), EGFR-expressing metastatic colorectal cancer as determined by FDA-approved tests for this use. ...
Proton Therapy System Granted 510(k) Clearance
Mevion Medical Systems, Inc, announced that it has received FDA 510(k) clearance for its Mevion S250 Proton Therapy System. According to Mevion, the new system delivers precise, noninvasive treatment comparable to that available with larger, more complex proton therapy systems but with higher patien...
Regorafenib in Metastatic Colorectal Cancer
Bayer HealthCare and Onyx Pharmaceuticals announced that the FDA has granted priority review designation to Bayer HealthCare’s New Drug Application (NDA) filed end of April 2012 for the oral multikinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer whose dise...
System for Breast Cancer Surgeries Gets Positive Vote
Dune Medical Devices announced that an FDA Advisory Panel voted 10 to 1 in favor of Dune’s MarginProbe System for use in breast cancer surgery, as an adjunct to current standard methods of intraoperative surgical margin assessment. Dune submitted a Premarket Application (PMA) in April 2011 based on ...
Blood Test to Improve Prostate Cancer Detection
Beckman Coulter, Inc, recently announced Premarket Approval from the FDA for the Prostate Health Index, a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than prostate-specific antigen (PSA) in patients with PSA values in the 4 to 10 ng/mL range and has be...
Novel Agent Carfilzomib Receives Positive Vote from Oncologic Drugs Advisory Committee for Use in Multiple Myeloma
Onyx Pharmaceuticals recently announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11–0 (with 1 abstention) that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor...
FDA Approves Pertuzumab for HER2-positive Metastatic Breast Cancer
The FDA has approved pertuzumab (Perjeta), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage breast cancer. Intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy, pertuzumab is combined with trastuzum...
Supplemental New Drug Application Submitted for Abiraterone
Janssen Research & Development, LLC, has submitted a supplemental New Drug Application (sNDA) to the FDA to extend the use of abiraterone acetate (Zytiga) administered with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildl...
Drug Safety Communication Issued Regarding Lenalidomide and Risk of New Malignancies
The FDA recently released a safety announcement about an increased risk of second primary malignancies in patients with newly diagnosed multiple myeloma who received treatment with lenalidomide (Revlimid). Clinical trials conducted after lenalidomide was approved showed that newly diagnosed patients...
FDA Approves Drugs Faster than Canadian and European Counterparts
According to a study published online in The New England Journal of Medicine (May 16, 2012), the FDA approved more new drugs in less time—about 15% faster—than the European Medicines Agency and Health Canada. The analysis compared drug review performance for the three agencies from 2001 to 2010. The...
Aflibercept Granted Priority Review for Metastatic Colorectal Cancer
Sanofi and Regeneron Pharmaceuticals, Inc, recently announced that the FDA has granted Priority Review of the Biologics License Application (BLA) for the investigational agent aflibercept (Zaltrap) concentrate for solution for infusion in combination with irinotecan/fluoropyrimidine–based chemothera...
FDA-led Research Team Discovers Autoimmune Mechanism for Drug-induced Adverse Reactions
A team of researchers led by the FDA has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions. In an article available online in the journal AIDS, the team reported that in certain at-risk patients, the anti-HIV drug abacavir (Ziagen) causes the immune syste...
New Drug Application Submitted for Regorafenib for the Treatment of Metastatic Colorectal Cancer
Bayer HealthCare announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for the oral multikinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer. The submission is based on the results of the pivotal, global phase III CORRECT (C...
New Breast Biopsy System with Vacuum Technology Approved
Devicor Medical Products, Inc, announced that it has received 510(k) clearance from the FDA for the Mammotome elite Biopsy System, a tetherless single-insertion, multiple-sample, vacuum-assisted biopsy device featuring proprietary vacuum technology. Devicor also announced the commercial launch of th...
FDA Approves Pazopanib for Advanced Soft-tissue Sarcoma
The FDA has approved pazopanib (Votrient) to treat patients with advanced soft-tissue sarcoma who have previously received chemotherapy. Pazopanib is an oral agent that works by interfering with angiogenesis. Soft-tissue sarcoma occurs in about 10,000 cases annually in the United States. More tha...
FDA Strengthens International Collaboration to Ensure Quality, Safety of Imported Products
FDA Commissioner Margaret A. Hamburg, MD, recently released the agency’s Global Engagement Report, detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency. The report describes the steps the agency is taking to ensure that imported fo...
Automated HER2 Immunohistochemical System Approved
Leica Biosystems, a division of Leica Microsystems, announced that it has received premarket approval from the FDA for its Bond Oracle HER2 IHC System, a semi-quantitative immunohistochemical assay to determine human epidermal growth factor receptor 2 oncoprotein status in formalin-fixed, paraffin...
FDA Reminds Public about Potential for Life-threatening Harm from Accidental Exposure to Fentanyl Patches
The FDA has issued a statement reminding patients, caregivers, and health-care professionals of the importance of appropriate storage, use, application, and disposal of fentanyl transdermal systems (including Duragesic and generic products) to prevent potential life-threatening harm from accidental ...
FDA Strengthens Monitoring of Postapproval Drug Safety
A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the FDA’s oversight of drugs once they reach the American public, according to a new report released by the agency’s Center for Drug Evaluation and Research (CDER). The report, Advances in FDA’s...
ASCO President Michael P. Link, MD, Makes Statement on Passage of FDA Safety and Innovation Act
ASCO President Michael P. Link, MD, recently issued the following statement in response to the Senate Health, Education, Labor and Pensions Committee’s Passage of the FDA’s Safety and Innovation Act: “ASCO commends the Senate Health, Education, Labor and Pensions Committee for taking steps to addre...
FDA Approves Investigational New Drug Application for Clinical Testing of Oncology Drug Candidate ME-344
Marshall Edwards, Inc, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced that it has received approval from the FDA of its Investigational New Drug (IND) application for ME-344, the Company’s lead mitochondrial inhibitor. The Compa...
ODAC Offers Recommendations on Two Sarcoma Drugs
The ASCO Post
The FDA’s Oncologic Drugs Advisory Committee (ODAC) recently recommended approval of one drug for sarcoma but rejected another. The panel voted 11 to 2 that clinical studies support a favorable benefit-risk assessment for use of pazopanib (Votrient) in treating patients with advanced soft-tissue s...
FDA Approves New Silicone Gel–filled Breast Implant
The ASCO Post
The FDA recently approved a silicone gel-filled breast implant manufactured by Sientra Inc for breast augmentation in women at least 22 years old and breast reconstruction in women of any age. As a condition of approval, Sientra is required to conduct postapproval studies that will assess long-term ...
Liposomal Vincristine Receives Positive Vote from ODAC
The ASCO Post
Talon Therapeutics, Inc, announced the Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain that evidence from clinical studies supports a favorable benefit-risk assessment for use of vincristine sulfate liposomes injection (Marqibo). The manufacturer is seeking an indication for the ...
FDA Drug Approvals, January–April 2012
The ASCO Post
Imatinib mesylate tablets (Gleevec) approved for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST). Vismodegib capsules (Erivedge) approved for the treatment of metastatic basal cell carcinoma or locally adva...
FDA Acts to Bolster Supply of Critically Needed Cancer Drugs
The ASCO Post
The FDA has announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages. The President’s order, issued last October 31, directed the FDA to take action to help further prevent and reduce pre...
New Colonoscopy System Cleared by FDA
The ASCO Post
A developer of endoscopy products based in New York and Kissing, Germany, invendo medical, announced that the company received 510(k) clearance by the FDA of the company’s new C20 colonoscopy system, including the SC20 single-use colonoscope. The invendoscope SC20 has several features that are n...
ODAC Votes against Denosumab to Delay Bone Metastasis in Men with Castration-resistant Prostate Cancer
The ASCO Post
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 1 that the risk-benefit ratio was insufficient for an expanded use of denosumab (Xgeva) to delay the spread of prostate cancer to the bone in men with castration-resistant disease. The panel was not asked specifically whether it recom...
Ki-67 Image Analysis and Digital Read Applications Cleared
The ASCO Post
Ventana Medical Systems, Inc, received 510(k) clearance from the FDA for the Ventana Companion Algorithm Ki-67 (30-9) image analysis application used with the Ventana iScan Coreo Au scanner running Virtuoso software. Ventana is currently the only company offering an FDA-cleared Ki-67 image analysi...
First Urine-based Molecular Test to Gauge Need for Repeat Prostate Biopsies
The ASCO Post
Gen-Probe announced the FDA has approved its PROGENSA PCA3 (prostate cancer gene 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. “Overexpression of the PCA3 gene is highly specific to cancerous prostate tis...
FDA Drug Approvals, January–March 2012
The ASCO Post
Imatinib mesylate tablets (Gleevec) approved for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST). Accelerated approval for this indication was granted in December 2008. Vismodegib (Erivedge) capsules approv...
FDA Issues Draft Guidance on Biosimilar Product Development
The FDA recently issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. “When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at ever...
Pertuzumab Gets Priority Review for Metastatic Breast Cancer
The FDA has accepted Roche’s Biologics License Application for pertuzumab (Omnitarg) and granted Priority Review. The proposed indication is pertuzumab in combination with trastuzumab (Herceptin) and docetaxel chemotherapy for people with HER2-positive metastatic or locally recurrent, unresectable...
Axitinib Receives FDA Approval in Advanced Renal Cell Carcinoma
The ASCO Post
The FDA has approved the kinase inhibitor axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. The approval is based on an international, randomized, open-label trial that enrolled 723 patients: 361 were assigned to receive axitinib at 5...
FDA Approves Vismodegib for Basal Cell Carcinoma
The ASCO Post
The FDA has approved vismodegib (Erivedge) to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients with metastatic disease...
Ingenol Mebutate Approved for Topical Actinic Keratosis Therapy
The ASCO Post
The FDA has approved ingenol mebutate (Picato) gel for the topical treatment of actinic keratosis. At a concentration of 0.015%, the gel is used once daily on the face and scalp for 3 consecutive days, whereas a 0.05% dosage form is used once daily on the trunk and extremities for 2 consecutive days...
Glucarpidase Approved to Treat Methotrexate Toxicity
The ASCO Post
The FDA has approved intravenous glucarpidase (Voraxaze) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Glucarpidase is an enzyme that rapidly reduces methotrexate levels by breaking down the chemotherapy drug to a form that can be eliminated from the bod...
Shared REMS Approved for all Transmucosal Immediate-release Fentanyl Products
The ASCO Post
The FDA has approved a new transmucosal immediate-release fentanyl Risk Evaluation and Mitigation Strategy (REMS) access program. The REMS is a single shared system for all transmucosal immediate-release fentanyl products. Among the goals of the REMS access program are to mitigate the risk of misuse...
FDA Completes Work on Three Drug User Fee Programs
The ASCO Post
The FDA recently completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biologic products to patients, according to FDA Commissioner Margaret A. Hamburg, MD. The programs include the fifth authorization of ...
Subcutaneous Bortezomib Approved
The ASCO Post
The FDA has approved a supplemental new drug application for bortezomib (Velcade), updating the label to include the subcutaneous administration in all indications approved for intravenous administration, ie, multiple myeloma and mantle cell lymphoma after at least one prior therapy. The approval w...
Integration of QOPI® Helps Michigan Insurer Earn ‘Best of Blue’ Award
By working to improve oncology care in practices in Michigan through integration of ASCO’s Quality Oncology Practice Initiative (QOPI) into its Physician Group Incentive Program, Blue Cross Blue Shield of Michigan (BCBSM) has been selected as a 2011 “Best of Blue Clinical Distinction Award” winner b...
FDA Approves Imatinib for Expanded Use in GIST
The ASCO Post
The FDA has granted imatinib mesylate (Gleevec) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). The new approval also highlights an increase in overall patient survival when the drug is taken for 36 months rather than th...
ODAC Backs Axitinib for Kidney Cancer
The ASCO Post
The FDA’s Oncologic Drugs Advisory Committee voted 13-0 that Pfizer’s drug axitinib (Inlyta) had a favorable benefit-risk profile for patients with advanced renal cell carcinoma after initial treatment has failed. The FDA is due to make a final decision in the first half of 2012. Panelists said the...
New System for Cervical Cancer Screening Approved
The ASCO Post
Hologic announced that the FDA has approved its Cervista HTA (high throughput automation) system for use with its previously approved Cervista human papillomavirus (HPV) HR test. The Company’s Cervista HTA system automates the DNA extraction and detection steps of the Hologic Cervista HPV HR test, a...
Investigational New Drug Application Filed for ONT-10
The ASCO Post
Oncothyreon Inc announced the filing of an Investigational New Drug (IND) application with the FDA for ONT-10, a therapeutic vaccine directed at cancers expressing MUC1. Upon completion of the FDA’s review of the IND, Oncothyreon expects to initiate a phase I trial. ONT-10 is a therapeutic vaccine ...
Package Inserts Revised for IV Methotrexate Products
The ASCO Post
The FDA has approved changes to the package inserts for methotrexate products for intravenous administration. Additional information regarding concomitant proton pump inhibitor (PPI) therapy has been added to the Warning section of the label. Specifically, the new text includes the following stateme...
FDA Announces Bevacizumab Decision: Agency Will Revoke Breast Cancer Indication
The ASCO Post
On November 18, FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for bevacizumab (Avastin) after concluding that the drug has not been shown to be safe and effective for that use. Bevacizumab will remain on the market as an approve...
Breast Cancer Experts Voice Opinion and Express ‘Disappointment’ over FDA Decision
Caroline Helwick
Gabriel N. Hortobagyi, MD, Chair of Medical Breast Oncology at The University of Texas MD Anderson Cancer Center, Houston, said he was “disappointed but not surprised” at the FDA decision to withdraw the bevacizumab (Avastin) indication in breast cancer. “Once the FDA put this in the hands of ODAC,...
2011 in Review: Oncology Drugs/Indications Newly Approved by FDA
The ASCO Post
At press time, the FDA had granted approval for the following new agents and indications for cancer treatment in 2011. Asparaginase Erwinia chrysanthemi (Erwinaze) as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in patients who have develo...
New Drug Approved to Treat Acute Lymphoblastic Leukemia
The ASCO Post
The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze) to treat patients with acute lymphoblastic leukemia who have developed hypersensitivity to Escherichia coli–derived asparaginase (Elspar) and pegaspargase (Oncaspar). Acute lymphoblastic leukemia is the most commonly diagnosed childho...
FDA Approves First Drug to Treat Myelofibrosis
The ASCO Post
The FDA has approved ruxolitinib (Jakafi), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis. Myelofibrosis is a disease in which the bone marrow is replaced by scar tissue resulting in blood cells being made in organs such as the liver and the spleen...
510(k) Clearance Granted for OncoTrac
The ASCO Post
Translational Sciences Corporation announced that it has received FDA 510(k) clearance for commercialization of its OncoTrac medical imaging software. OncoTrac is designed for efficient quantitative assessment of treatment response of metastatic tumors including those of the breast, lung, colorectal...
FDA Approves Molecular Test to Detect HPV
The ASCO Post
Gen-Probe recently announced that the FDA has approved its APTIMA HPV assay, an amplified nucleic acid test that detects high-risk strains of human papillomavirus (HPV) that are associated with cervical cancer and precancerous lesions. The test has been approved to run on Gen-Probe’s fully automated...
VGX-100 Investigational New Drug Application Approved
The ASCO Post
The Australian biotechnology company Circadian Technologies announced that its subsidiary, Vegenics Pty Ltd, has received approval for its investigational new drug (IND) application from the FDA to initiate clinical trials of VGX-100. The first phase I trial will study VGX-100 in patients with a v...
Test for AML Prognosis Cleared by FDA
The ASCO Post
Abbott announced today it has received 510(k) clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with acute myeloid leukemia (AML) Abbott’s Vysis EGR1 FISH Probe Kit, the third Abbott fluorescence in situ hybridization (FISH) assay approved or c...
FDA Approves Cetuximab to Treat Metastatic Head and Neck Cancer
The ASCO Post
On November 7, the FDA approved cetuximab (Erbitux) in combination with platinum-based therapy plus fluorouracil (5-FU) for the first-line treatment of patients with recurrent locoregional disease and/or metastatic squamous cell carcinoma of the head and neck. The approval was based primarily on the...
FDA Commissioner Announces Decision on Bevacizumab
The ASCO Post
On November 18, FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for bevacizumab (Avastin) after concluding that the drug has not been shown to be safe and effective for that use. Bevacizumab will still remain on the market as an a...
FDA Issues Safety Announcement on Dasatinib
The ASCO Post
The FDA is warning the public that the leukemia drug dasatinib (Sprycel) may increase the risk of pulmonary arterial hypertension (PAH). Information about this risk has been added to the Warnings and Precautions section of the dasatinib drug label. In reported cases, patients developed PAH after st...
Gel for Blood Vessel Surgery Approved
The ASCO Post
The FDA has approved LeGoo (PluroMed Inc, Woburn, Mass), a gel that allows surgeons to temporarily stop blood flow during surgery so that they can join blood vessels without clamps or elastic loops. LeGoo has been shown to minimize blood flow into the surgical area without damaging blood vessels. T...
Bevacizumab Labeling Revised to Include New Risks
The ASCO Post
The FDA recently announced changes made to the bevacizumab (Avastin) package insert regarding new safety concerns. These changes include the following: A new Warning subsection describing the increased risk of ovarian failure in premenopausal patients receiving bevacizumab and chemotherapy and re...
FDA Approves Denosumab to Increase Bone Mass in Patients with Cancer
The ASCO Post
Denosumab (Prolia) recently received FDA approval as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer. Pivotal Trials The approvals were base...
New Biomarker Test Cleared to Evaluate Ovarian Cancer Likelihood
The ASCO Post
Fujirebio Diagnostics announced that it has received 510(k) clearance from the FDA to market the company’s HE4 Test in an algorithm called ROMA to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding mali...
FDA Announces Changes in Drug Center’s Oncology Office
The ASCO Post
The FDA recently announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and O...
FDA Approves Brentuximab Vedotin in Two Lymphoma Indications
Matthew Stenger
The antibody-drug conjugate brentuximab vedotin (Adcetris) was granted accelerated approval on August 19 for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma. Brentuximab vedotin is the first new drug to be approved in Hodgkin lymphoma in more than...
Novel BRAF Inhibitor Receives FDA Approval in Metastatic Melanoma
Caroline Helwick
Vemurafenib (Zelboraf) received FDA approval on August 17, 2011, for treatment of metastatic or unresectable melanoma, based on the results of the phase III BRIM3 trial.1 BRIM3 compared vemurafenib to dacarbazine in 675 untreated patients with the BRAF V600E mutation. Vemurafenib targets the mutatio...
FDA Grants Orphan Drug Status to MM-398, a Nanotherapeutic Encapsulation of Irinotecan, to Treat Pancreatic Cancer
The ASCO Post
Merrimack Pharmaceuticals, Inc, announced that the FDA has granted MM-398 orphan drug status for the treatment of pancreatic cancer. MM-398 is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. MM-398 is partnered with PharmaEngine, Inc, for development and c...
Action Date Set for Denosumab Supplemental Application
The ASCO Post
Amgen announced that the FDA will target a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012, for the supplemental Biologics License Application to expand the indication for denosumab (Xgeva) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bon...
FDA Clears Genetic FISH Panel for Leukemia Patient Prognosis
The ASCO Post
Abbott announced it has received 510k clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with chronic lymphocytic leukemia (CLL). Abbott’s Vysis CLL FISH Probe Kit is the first FDA-cleared CLL test to aid in prognosis. The test detects genetic a...
Radium-223 Chloride Gets Fast Track Designation
The ASCO Post
Bayer HealthCare Pharmaceuticals, Inc, announced that its investigational compound radium-223 chloride, which is exclusively licensed from Algeta ASA, has been granted Fast Track designation by the FDA for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with bo...
Crizotinib plus Companion Diagnostic Test Approved in NSCLC
The ASCO Post
On August 26, 2011, the FDA granted accelerated approval to Pfizer’s crizotinib (Xalkori) for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA approved the f...
Updated Drug Label Approved for Pioglitazone after Safety Review
The ASCO Post
The FDA recently approved updated drug labels for pioglitazone (Actos) and other pioglitazone-containing medicines (in combination with metformin, Actoplus Met and Actoplus Met XR; and with glimepiride, Duetact) to include safety information that the use of pioglitazone for more than 1 year may be a...
FDA Issues Guidance for Diagnostic Tests Used with Targeted Therapies
The ASCO Post
The FDA issued a new draft guidance to facilitate the development and review of “companion diagnostics”—tests used to help health-care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft ...
ODAC Recommends Accelerated Approval for Brentuximab
The ASCO Post
Seattle Genetics, Inc, announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend that the agency grant accelerated approval of brentuximab vedotin (ADCETRIS) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant (ASCT)....
New Safety Information Reported for 5-alpha Reductase Inhibitors
The ASCO Post
The FDA announced that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor class of drugs has been revised to include new safety information about the increased risk of being diagnosed with high-grade prostate cancer. This risk appears to be low, but health-care pr...
FDA Outlines Oversight of Mobile Medical Applications
The ASCO Post
The FDA is seeking input on its proposed oversight approach for mobile medical applications (“apps”) designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications, and will not regulate the sal...
Final Decision on Sipuleucel-T
The Centers for Medicare & Mediaid Services (CMS) issued a final decision to cover FDA-approved indications of sipuleucel-T (Provenge) in prostate cancer, calling the treatment “reasonable and necessary.” The CMS final decision assures provider reimbursement of sipuleucel-T for Medicare benefici...
ODAC Again Recommends FDA Withdraw Its Approval of Bevacizumab for Metastatic Breast Cancer
In June 2011, a public hearing was convened to consider an appeal of the December 2010 recommendation by FDA to remove the breast cancer indication for bevacizumab (Avastin). FDA’s recommendation late last year was in accordance with a July 2010 recommendation by the Oncologic Drugs Advisory Committ...
First Fentanyl Nasal Spray Approved for Cancer Breakthrough Pain
The FDA has approved fentanyl nasal spray (Lazanda) for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. This marks the first FDA product approval for Archime...
FDA Issues Updated Safety Data on Silicone Gel–filled Breast Implants
The FDA has released a report updating the clinical and scientific information for silicone gel–filled breast implants, including preliminary safety data from studies conducted by the manufacturers (Allergan and Mentor) as a condition of their November 2006 approval. While the report confirms tha...
Test Approved to Help Determine Candidacy for Trastuzumab
The FDA has approved a new genetic test that will help health-care professionals determine whether women with breast cancer are HER2-positive and, therefore, candidates for trastuzumab (Herceptin). The test, called Inform Dual ISH, allows for measurement of the number of copies of the HER2 gene in t...
Changes Introduced to Better Inform Consumers about Sunscreen
The FDA announced that sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn. The final...
New Drug Application Submitted for Vemurafenib in Melanoma
Daiichi Sankyo announced that applications have been submitted for market approval for vemurafenib (PLX4032/RG7204) for the treatment of metastatic melanoma to the FDA and the European Medicines Agency (EMA). Additionally, a premarketing application for approval for a companion diagnostic test has b...
FDA Approves Sunitinib for Pancreatic Neuroendocrine Tumors
The FDA approved sunitinib (Sutent) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have metastasized. This is the second new approval by the FDA to treat patients with this disease. On May 5, the agency approved e...
Trabectedin New Drug Application Withdrawn
Centocor Ortho Biotech Products, LP, announced that it has voluntarily withdrawn the New Drug Application (NDA) for trabectedin (Yondelis) for the treatment of women with recurrent ovarian cancer. The withdrawal is based on the FDA’s recommendation that an additional phase III study be conducted to ...
FDA Issues Revised Draft Guidance on Financial Disclosure by Clinical Investigators
The FDA recently issued a draft guidance on financial disclosure by clinical investigators, intended to assist researchers, industry, and FDA staff in interpreting and complying with regulations found in the Code of Federal Regulations Title 21, Part 54. The draft is being distributed for comment pu...
Kieron M. Dunleavy, MD, on B-Cell Malignancies: Novel-Novel Drug Combinations
Sara A. Hurvitz, MD, on HR+/HER2− Advanced Breast Cancer: MONALEESA-7 Trial on Endocrine Therapy With or Without Ribociclib
Mark K. Ferguson, MD, on Mitigating Frailty and Sarcopenia to Improve Treatment Outcomes
Frederick L. Locke, MD, on Innovative CAR-T Cell Therapies: The Patient Experience
Hope S. Rugo, MD, and Matteo Lambertini, MD, PhD, on the SOPHIA Trial in HER2-Positive Metastatic Breast Cancer: Chemotherapy Plus Margetuximab vs Trastuzumab
