FDA Update
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...
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 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...
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...
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,...
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 will make...
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...
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...
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 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 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...
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...
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...
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...
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...
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 ...
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 ...
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...
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...
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 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...
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 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...
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 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...
FDA Approves Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer
The ASCO Post
ON JULY 30, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa) for the treatment of nonmetastatic castration-resistant prostate cancer. Approval was based on the ARAMIS study, a multicenter, double-blind, placebo-controlled clinical trial of 1,509 patients with nonmetastatic...
FDA Approves Rituximab Biosimilar
The ASCO Post
On July 24, the U.S. Food and Drug Administration (FDA) approved rituximab-pvvr -(Ruxience), a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis and microscopic polyangi-itis. Rit...
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 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 foll...
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 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...
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...
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...
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...
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...
FDA Approves Pexidartinib for Tenosynovial Giant Cell Tumor
The ASCO Post
ON AUGUST 2, the U.S. Food and Drug Administration (FDA) granted approval to pexidartinib (Turalio) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not responsive to improvement with surgery. ...
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 ...
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 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 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...
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 innova...
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...
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 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...
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...
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...
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...
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...
FDA Approves Fedratinib for Treatment of Myelofibrosis
The ASCO Post
On August 16, the U.S. Food and Drug Administration (FDA) approved the Janus kinase 2 (JAK2) inhibitor fedratinib (Inrebic) for the treatment of adults with intermediate-2 or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis. “Prior to [this app...
FDA Clears Next-Generation Scalp-Cooling Device
The ASCO Post
ON JUNE 27, 2019, the U.S. Food and Drug Administration (FDA) granted clearance of the DigniCap Delta scalp-cooling system to Dignitana, for use by health-care providers in the United States. The device is a fourth generation of the DigniCap scalp-cooling system. It is indicated to reduce the freque...
