FDA Update

CNS Cancers

FDA Approves Aminolevulinic Acid Hydrochloride as an Optical Imaging Agent Indicated in Gliomas

The ASCO Post  / July 10, 2017

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...

Multiple Myeloma

FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

The ASCO Post  / July 10, 2017

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 ...

Colorectal Cancer

FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer

The ASCO Post  / July 10, 2017

Marwan G. Fakih, MD 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 t...

Multiple Myeloma

FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

The ASCO Post  / June 25, 2017

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 (...

Solid Tumors
Colorectal Cancer

FDA Approves Pembrolizumab for First Tissue/Site-Agnostic Indication

The ASCO Post  / June 10, 2017

Richard Pazdur, MD 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...

Lung Cancer

FDA Broadens Ceritinib Indication

The ASCO Post  / June 10, 2017

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  / June 3, 2017 - Narratives Special Issue

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...

Skin Cancer

FDA Approves Avelumab for Metastatic Merkel Cell Carcinoma

The ASCO Post  / April 10, 2017

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...

Gynecologic Cancers

FDA Approves Maintenance Niraparib for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The ASCO Post  / April 10, 2017

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...

Multiple Myeloma

FDA Approves Lenalidomide as Maintenance Therapy for Patients With Multiple Myeloma Following Autologous Stem Cell Transplant

The ASCO Post  / March 10, 2017

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 T...

Lymphoma

FDA Approves Ibrutinib in Relapsed/Refractory Marginal Zone Lymphoma

The ASCO Post  / February 25, 2017

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  / February 10, 2017

Richard Pazdur, MD This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics, and devices across the agency’s three medical product centers. — Robert Califf, MD (right) On January 19, 2017, U.S. Food and Drug Adminis...

Health-Care Policy

Oncology Drug Approvals in 2016

The ASCO Post  / January 25, 2017

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...

Pain Management

FDA Approves Extended-Release Morphine Product Formulated With Abuse-Deterrent Properties

The ASCO Post  / January 25, 2017

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...

Multiple Myeloma

FDA Approves Daratumumab in Combination Therapy for Patients With Multiple Myeloma Receiving at Least One Prior Treatment

The ASCO Post  / December 10, 2016

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...

Head and Neck Cancer

FDA Approves Nivolumab for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

The ASCO Post  / November 25, 2016

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...

Lung Cancer

FDA Approves Pembrolizumab as First-Line Treatment for PD-L1–Positive Non–Small Cell Lung Cancer

The ASCO Post  / November 10, 2016

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...

Sarcoma

FDA Grants Accelerated Approval to Olaratumab for Treatment of Advanced Soft-Tissue Sarcoma

The ASCO Post  / November 10, 2016

This is the first new therapy approved by the FDA for the initial treatment of soft-tissue sarcoma since doxorubicin's approval more than 40 years ago. — Richard Pazdur, MD Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to olaratu...

Leukemia

FDA Approves Ofatumumab in Combination With Fludarabine and Cyclophosphamide for Relapsed CLL

The ASCO Post  / September 25, 2016

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...

Lung Cancer

FDA Grants Priority Review to Pembrolizumab Supplemental Biologics License Application for First-Line Treatment of Advanced NSCLC

The ASCO Post  / September 25, 2016

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 (...

Leukemia

FDA Approves Blinatumomab for Use in Pediatric Patients With Ph-Negative Relapsed or Refractory B-Cell Precursor ALL

The ASCO Post  / September 25, 2016

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...

Lymphoma

FDA Grants Orphan Drug Designation to CD4CAR for the Treatment of Peripheral T-Cell Lymphoma

The ASCO Post  / September 10, 2016

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 William Tse, MD, Chief of the Blood and Marrow ...

Head and Neck Cancer

FDA Approves Pembrolizumab for Metastatic Head and Neck Squamous Cell Carcinoma

The ASCO Post  / August 25, 2016

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 ...

Symptom Management

FDA Approves Extended-Release Granisetron Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting

The ASCO Post  / August 25, 2016

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...

Gynecologic Cancers

FDA Approves First HPV Test for Use With SurePath Preservative Fluid

The ASCO Post  / August 10, 2016

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  / August 10, 2016

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

The ASCO Post  / July 25, 2016

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

The ASCO Post  / July 10, 2016

Richard Pazdur, MD 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...

Richard Pazdur, MD, Named Acting Director of FDA’s Oncology Center of Excellence

The ASCO Post  / July 10, 2016

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...

Prostate Cancer

FDA Approves New Diagnostic Imaging Agent to Detect Recurrent Prostate Cancer

The ASCO Post  / June 10, 2016

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...

Neuroendocrine Tumors

FDA Approves New Diagnostic Imaging Agent to Detect Rare Neuroendocrine Tumors

The ASCO Post  / June 10, 2016

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 s...

Lymphoma

FDA Approves Nivolumab for Heavily Pretreated Classical Hodgkin Lymphoma

The ASCO Post  / May 25, 2016

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...

Thyroid Cancer

FDA Grants Selumetinib Orphan Drug Designation for Adjuvant Treatment of Differentiated Thyroid Cancer

The ASCO Post  / May 25, 2016

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...

Issues in Oncology

FDA Maintains Ongoing Efforts to Expedite Drug Approvals

The ASCO Post  / May 25, 2016

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...

Lung Cancer

ODAC Advises the FDA to Wait for Phase III Results for Rociletinib in Non–Small Cell Lung Cancer

Kirsten Boyd Goldberg  / May 25, 2016

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...

Kidney Cancer

FDA Approves Lenvatinib in Combination With Everolimus in Advanced Renal Cell Carcinoma

The ASCO Post  / May 25, 2016

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...

Kidney Cancer

FDA Approves Cabozantinib in Patients With Renal Cell Carcinoma Who Have Received Prior Antiangiogenic Therapy

The ASCO Post  / May 10, 2016

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...

Lung Cancer

FDA Approves Crizotinib for ROS1-Positive Metastatic Non–Small Cell Lung Cancer

The ASCO Post  / March 25, 2016

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 ...

Solid Tumors

FDA Approves Everolimus for Neuroendocrine Tumors of GI or Lung Origin

The ASCO Post  / March 25, 2016

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 ...

Lymphoma

FDA Approves Obinutuzumab in Follicular Lymphoma

The ASCO Post  / March 25, 2016

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...

Skin Cancer

Pembrolizumab Label Updated With New Clinical Trial Information

The ASCO Post  / February 10, 2016

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...

Leukemia

FDA Approves Ofatumumab for Patients With Chronic Lymphocytic Leukemia in Complete or Partial Response

The ASCO Post  / February 10, 2016

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)...

Solid Tumors
Hematologic Malignancies

FDA Oncology New Drug/New Indication Approvals for 2015

The ASCO Post  / December 25, 2015

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 ...

Solid Tumors
Hematologic Malignancies

November Yields Record Number of FDA Approvals for New Oncology Drugs and Drug Indications

Jo Cavallo  / December 10, 2015

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...

Multiple Myeloma

FDA Approves Elotuzumab in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma

The ASCO Post  / December 10, 2015

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...

Kidney Cancer
Skin Cancer

Nivolumab Receives Two FDA Approvals in November

The ASCO Post  / December 10, 2015

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...

Lung Cancer

FDA Approves Necitumumab Combination for Metastatic Squamous NSCLC

The ASCO Post  / December 10, 2015

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...

Skin Cancer

FDA Approves Cobimetinib in Combination With Vemurafenib for Metastatic Melanoma

The ASCO Post  / November 25, 2015

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...

Multiple Myeloma

Daratumumab Approved in Multiple Myeloma

The ASCO Post  / November 25, 2015

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...

Sarcoma

FDA Approves Trabectedin for Advanced Liposarcoma and Leiomyosarcoma

The ASCO Post  / November 10, 2015

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 ...

Pancreatic Cancer

FDA Approves Liposomal Irinotecan for Advanced Pancreatic Cancer

The ASCO Post  / November 10, 2015

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...

Skin Cancer

FDA Approves Ipilimumab in Adjuvant Treatment of Stage III Melanoma

The ASCO Post  / November 10, 2015

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 ...

Leukemia

Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia

The ASCO Post  / November 10, 2015

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 ...

Skin Cancer

FDA Approves First Oncolytic Viral Therapy in the United States

The ASCO Post  / November 10, 2015

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...

Lung Cancer

FDA Approves Use of Nivolumab in Metastatic Nonsquamous Lung Cancer

The ASCO Post  / October 25, 2015

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...

CNS Cancers

FDA Grants Orphan Drug Designation to Bivalent Vaccine for Neuroblastoma

The ASCO Post  / October 25, 2015

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 ...

Lung Cancer

FDA Grants Accelerated Approval to Pembrolizumab for Advanced NSCLC

The ASCO Post  / October 25, 2015

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...

CNS Cancers

FDA Approves Expanded Indication for Medical Device to Treat Newly Diagnosed Glioblastoma Multiforme

The ASCO Post  / October 25, 2015

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...

Colorectal Cancer

FDA Approves New Oral Medication for the Treatment of Refractory Metastatic Colorectal Cancer

The ASCO Post  / October 10, 2015

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...

Symptom Management

FDA Approves Rolapitant for Prevention of Chemotherapy-Induced Nausea and Vomiting

The ASCO Post  / September 25, 2015

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...

Lymphoma

FDA Grants Regular Approval to Brentuximab Vedotin in High-Risk Classical Hodgkin Lymphoma

The ASCO Post  / September 25, 2015

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...

Multiple Myeloma

FDA Accepts for Priority Review the Biologics License Application for Elotuzumab for the Treatment of Relapsed Multiple Myeloma

The ASCO Post  / September 25, 2015

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...

Multiple Myeloma

FDA Approves Carfilzomib Combination for Patients With Relapsed Multiple Myeloma

The ASCO Post  / August 25, 2015

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...

Kidney Cancer

FDA Grants Breakthrough Therapy Designation to Lenvatinib for Metastatic Renal Cell Carcinoma

The ASCO Post  / August 25, 2015

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...

Sarcoma

Dactinomycin Formulation Gets Orphan Drug Designation

The ASCO Post  / August 25, 2015

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 ...

Skin Cancer

FDA Approves Sonidegib for Locally Advanced Basal Cell Carcinoma

The ASCO Post  / August 25, 2015

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...

CNS Cancers

FDA Grants Orphan Drug Designation to Antitropomyosin Drug for Neuroblastoma

The ASCO Post  / August 10, 2015

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...

Lung Cancer

ODAC Discussion ‘Constructive’ About Necitumumab for Squamous NSCLC

Kirsten Boyd Goldberg  / August 10, 2015

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...

Leukemia

Venetoclax Receives Breakthrough Therapy Designation in Relapsed/Refractory CLL With 17p Deletion

The ASCO Post  / May 25, 2015

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...

Pancreatic Cancer

FDA Grants Fast Track Designation to Evofosfamide for Advanced Pancreatic Cancer

The ASCO Post  / May 25, 2015

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...

Skin Cancer

FDA Accepts Supplemental Biologics License Application for Nivolumab in Patients With Previously Untreated Advanced Melanoma

The ASCO Post  / May 25, 2015

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...

Colorectal Cancer

Cobas KRAS Mutation Test Receives FDA Approval

The ASCO Post  / May 25, 2015

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...

Issues in Oncology

Building a Better Federal Oncology Workforce

Ronald Piana  / May 25, 2015

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 ...

Lung Cancer

Crizotinib Receives Breakthrough Therapy Designation for ROS1-Positive NSCLC

The ASCO Post  / May 10, 2015

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...

Colorectal Cancer

FDA Approves Ramucirumab for Metastatic Colorectal Cancer

The ASCO Post  / May 10, 2015

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...

Gynecologic Cancers

FDA Grants Breakthrough Therapy Designation to Rucaparib in Advanced Ovarian Cancer With BRCA Mutations

The ASCO Post  / April 25, 2015

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 ...

Multiple Myeloma

FDA Grants Priority Review to Carfilzomib Supplemental New Drug Application for Relapsed Multiple Myeloma

The ASCO Post  / April 25, 2015

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 ...

Issues in Oncology
Supportive Care

FDA Approves First Biosimilar Product Filgrastim-Sndz

The ASCO Post  / April 10, 2015

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...

Lung Cancer

FDA Approves Nivolumab to Treat Metastatic Squamous NSCLC

The ASCO Post  / April 10, 2015

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...

Supportive Care

FDA Approves Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis

The ASCO Post  / April 10, 2015

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...

Sarcoma

Priority Review Granted for Trabectedin in Advanced Soft-Tissue Sarcoma

The ASCO Post  / March 25, 2015

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 ...

CNS Cancers

Dinutuximab Combination Approved for Pediatric High-Risk Neuroblastoma

The ASCO Post  / March 25, 2015

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...

Breast Cancer

FDA Approves Palbociclib in Combination With Letrozole for Advanced Breast Cancer

The ASCO Post  / March 10, 2015

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...

Skin Cancer

FDA Grants Cobimetinib Priority Review for Use in Combination With Vemurafenib in Advanced Melanoma

The ASCO Post  / March 10, 2015

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...

Lung Cancer

FDA Grants Breakthrough Therapy Designation to MPDL3280A for Non–Small Cell Lung Cancer

The ASCO Post  / March 10, 2015

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...

Thyroid Cancer

FDA Approves Lenvatinib for Progressive Radioiodine-Refractory Differentiated Thyroid Cancer

The ASCO Post  / March 10, 2015

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...

Gynecologic Cancers
Pancreatic Cancer

Human Reovirus Formulation Gets Orphan Drug Designation in Ovarian and Pancreatic Cancer

The ASCO Post  / March 10, 2015

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...

Multiple Myeloma

FDA Approves Panobinostat Combination for the Treatment of Multiple Myeloma

The ASCO Post  / March 10, 2015

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...

Multiple Myeloma

FDA Approves Lenalidomide in Combination With Dexamethasone for Newly Diagnosed Multiple Myeloma

The ASCO Post  / March 10, 2015

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...

Lymphoma

FDA Expands Approved Use of Ibrutinib for Waldenström’s Macroglobulinemia

The ASCO Post  / February 10, 2015

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...

Leukemia

CPX-351 Receives Fast Track Designation for Secondary Acute Myeloid Leukemia in Elderly Patients

The ASCO Post  / February 10, 2015

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...

Multiple Myeloma

Supplemental New Drug Application for Carfilzomib

The ASCO Post  / February 10, 2015

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...

Skin Cancer

FDA Approves Nivolumab for Advanced Melanoma

The ASCO Post  / January 25, 2015

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...

Lung Cancer

FDA Approves Ramucirumab Combination for Non–Small Cell Lung Cancer

The ASCO Post  / January 25, 2015

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 ...

Gynecologic Cancers

FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer

The ASCO Post  / January 25, 2015

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...

Solid Tumors
Hematologic Malignancies

FDA Drug Approvals 2014

The ASCO Post  / January 25, 2015

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...

Gynecologic Cancers

FDA Approves Companion Diagnostic for the Detection of BRCA1/2 Mutations in Ovarian Cancer

The ASCO Post  / January 25, 2015

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...

Supportive Care

FDA Approves Denosumab for the Treatment of Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy

The ASCO Post  / January 25, 2015

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  / December 15, 2014

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...

Leukemia

FDA Grants Breakthrough Therapy Designation to Investigational CAR T-Cell Therapy

The ASCO Post  / December 15, 2014

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...

Leukemia

FDA Approves Blinatumomab to Treat Rare Form of Acute Lymphoblastic Leukemia

The ASCO Post  / December 15, 2014

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...

Pancreatic Cancer

Necuparanib Receives Fast Track Designation From the FDA for the Treatment of Metastatic Pancreatic Cancer

The ASCO Post  / December 15, 2014

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...

Hematologic Malignancies

FDA Approves Ruxolitinib to Treat Patients With Polycythemia Vera

The ASCO Post  / December 15, 2014

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...

Gynecologic Cancers

FDA Approves Bevacizumab Plus Chemotherapy for Platinum-Resistant, Recurrent Ovarian Cancer

The ASCO Post  / December 1, 2014

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...

Leukemia

FDA Grants Orphan Drug Designation to BGB324 for Acute Myeloid Leukemia

The ASCO Post  / December 1, 2014

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...

Pain Management

FDA Approves Extended-Release, Single-Entity Hydrocodone Product With Abuse-Deterrent Properties

The ASCO Post  / December 1, 2014

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...

Lung Cancer

FDA Grants Breakthrough Therapy Designation Pembrolizumab in Advanced Non–Small Cell Lung Cancer

The ASCO Post  / November 15, 2014

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...

Pain Management

FDA Approves Labeling With Abuse-Deterrent Features for Extended-Release Opioid Analgesic

The ASCO Post  / November 15, 2014

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 ...

Gastroesophageal Cancer

FDA Approves Ramucirumab in Combination With Paclitaxel for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

The ASCO Post  / November 15, 2014

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...

Lymphoma

FDA Approves Bortezomib Injection for Previously Untreated Patients With Mantle Cell Lymphoma

The ASCO Post  / November 1, 2014

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...

Supportive Care

FDA Approves Netupitant and Palonosetron Combination Capsule for Chemotherapy-Induced Nausea and Vomiting

The ASCO Post  / November 1, 2014

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...

Leukemia

Blinatumomab Receives FDA Priority Review Designation in Acute Lymphoblastic Leukemia

The ASCO Post  / November 1, 2014

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 ...

Thyroid Cancer

Lenvatinib Receives Priority Review Designation for Advanced Thyroid Cancer

The ASCO Post  / November 1, 2014

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...

Head and Neck Cancer

Lymphatic Mapping Agent Receives Orphan Drug Designation for Head and Neck Cancers

The ASCO Post  / October 15, 2014

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 ...

CNS Cancers

FDA Grants Orphan Drug Designation to Bivalent Vaccine for Neuroblastoma

The ASCO Post  / October 15, 2014

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 ...

CNS Cancers
Gynecologic Cancers
Lung Cancer

Aldoxorubicin Receives FDA Orphan Drug Designations for Glioblastoma, Small Cell Lung Cancer, and Ovarian Cancer

The ASCO Post  / October 15, 2014

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...

Skin Cancer

FDA Approves Pembrolizumab for Advanced Melanoma

The ASCO Post  / September 15, 2014

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...

Gynecologic Cancers

Novel Immunotherapy for Ovarian Cancer Receives Fast Track Designation

The ASCO Post  / September 15, 2014

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-...

Pancreatic Cancer

FDA Grants Fast Tract Designation to Investigational Combination Therapy In Metastatic Pancreatic Cancer

The ASCO Post  / September 15, 2014

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...

Neuroendocrine Tumors

FDA Grants Priority Review to Lanreotide Injection for Gastroenteropancreatic Neuroendocrine Tumors

The ASCO Post  / September 15, 2014

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...

Colorectal Cancer

FDA Approves First Noninvasive DNA Screening Test for Colorectal Cancer

The ASCO Post  / September 1, 2014

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...

Hematologic Malignancies

FDA Grants Fast Track Designation to Novel JAK2 Inhibitor for the Treatment of Myelofibrosis

The ASCO Post  / September 1, 2014

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...

Gynecologic Cancers

FDA Approves Bevacizumab for Aggressive and Late-Stage Cervical Cancer

The ASCO Post  / September 1, 2014

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 ...

Multiple Myeloma

FDA Approves Bortezomib Retreatment in Patients With Multiple Myeloma

The ASCO Post  / September 1, 2014

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...

Leukemia
Lymphoma

Recent FDA Drug Approvals Foster Growing Treatment Armamentarium for Chronic Lymphocytic Leukemia and Rare B-Cell Lymphomas

The ASCO Post  / August 15, 2014

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...

Gynecologic Cancers

FDA Grants Bevacizumab Priority Review for Certain Types of Cervical Cancer

The ASCO Post  / August 15, 2014

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...

Gynecologic Cancers

FDA Grants Bevacizumab Priority Review for Recurrent Platinum-Resistant Ovarian Cancer

The ASCO Post  / August 15, 2014

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...

Health-Care Policy

FDA Takes Steps to Help Ensure the Reliability of Certain Diagnostic Tests

The ASCO Post  / August 15, 2014

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...

Skin Cancer

FDA Commissioner Margaret A. Hamburg’s Statement on the Surgeon General’s Call to Action to Prevent Skin Cancer

Margaret A. Hamburg  / August 15, 2014

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...

Leukemia

FDA Grants Breakthrough Therapy Designation to Investigational Chimeric Antigen Receptor Therapy for Relapsed/Refractory ALL

The ASCO Post  / July 25, 2014

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...

Hepatobiliary Cancer

Orphan Drug Designation Granted for New Agent in Hepatocellular Carcinoma

The ASCO Post  / July 25, 2014

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...

Lymphoma

FDA Approves Belinostat for Relapsed or Refractory Peripheral T-Cell Lymphoma

The ASCO Post  / July 25, 2014

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...

Leukemia

FDA Grants Breakthrough Therapy Designation to Blinatumomab for Acute Lymphoblastic Leukemia

The ASCO Post  / July 25, 2014

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...

Issues in Oncology

FDA Drug Safety Communication: Docetaxel May Cause Symptoms of Alcohol Intoxication

The ASCO Post  / July 25, 2014

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...

Gynecologic Cancers

FDA Advisory Committee Votes Against Accelerated Approval for Olaparib in Ovarian Cancer

The ASCO Post  / July 10, 2014

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 ASCO Post  / July 10, 2014

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 ...

Head and Neck Cancer

Diagnostic Imaging Agent Approved for Use in Patients With Head and Neck Cancer

The ASCO Post  / July 10, 2014

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...

Breast Cancer

FDA Approves Magnetic Resonance Contrast Agent for Evaluation of Breast Cancer

The ASCO Post  / June 25, 2014

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...

Head and Neck Cancer

FDA Approves Radioactive Diagnostic Imaging Agent to Help Determine the Extent of Head and Neck Cancer in the Body

The ASCO Post  / June 25, 2014

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...

Supportive Care

FDA Approves Palonosetron Hydrochloride for Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients

The ASCO Post  / June 10, 2014

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...

Colorectal Cancer

FDA Approves Panitumumab Plus FOLFOX for  Wild-Type KRAS Metastatic Colorectal Cancer

The ASCO Post  / June 10, 2014

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...

Gastrointestinal Cancer

FDA Approves Ramucirumab for Stomach Cancer

The ASCO Post  / May 15, 2014

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...

Lung Cancer

FDA Approves Ceritinib for Late-Stage Lung Cancer

The ASCO Post  / May 15, 2014

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...

Hematologic Malignancies

FDA Approves Siltuximab for Rare Castleman’s Disease

The ASCO Post  / May 15, 2014

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...

Gynecologic Cancers

FDA Approves First HPV Test for Primary Cervical Cancer Screening

The ASCO Post  / May 15, 2014

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...

Issues in Oncology

FDA Proposes to Extend Its Tobacco Authority to Additional Tobacco Products, Including E-Cigarettes

The ASCO Post  / May 15, 2014

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...

Leukemia

Supplemental New Drug Application Submitted for Ibrutinib in CLL

The ASCO Post  / May 15, 2014

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 ...

Leukemia

Volasertib Granted Orphan Drug Designation for Acute Myeloid Leukemia

The ASCO Post  / May 15, 2014

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...

Gynecologic Cancers

FDA Discourages Use of Laparoscopic Power Morcellation for Removal of Uterus or Uterine Fibroids

The ASCO Post  / May 15, 2014

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...

Lymphoma

FDA Grants Orphan Drug Designation for Anti-CD19 T-Cell Cancer Immunotherapy Product

The ASCO Post  / May 1, 2014

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...

Leukemia

FDA Approves Ofatumumab for Previously Untreated Chronic Lymphocytic Leukemia

The ASCO Post  / May 1, 2014

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...

Hepatobiliary Cancer

Ethiodized Oil Approved for Imaging of Hepatocellular Carcinoma Tumors

The ASCO Post  / May 1, 2014

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 ...

Leukemia

Omacetaxine Mepesuccinate Receives Full FDA Approval for CML

The ASCO Post  / March 15, 2014

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...

Leukemia

FDA Grants Orphan Drug Status to Pracinostat for the Treatment of Acute Myeloid Leukemia

The ASCO Post  / March 15, 2014

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...

Leukemia

FDA Approves Ibrutinib for the Treatment of Chronic Lymphocytic Leukemia

The ASCO Post  / March 1, 2014

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...

Lymphoma

FDA Accepts New Drug Application for Idelalisib in Refractory Indolent Non-Hodgkin Lymphoma

The ASCO Post  / February 15, 2014

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...

Leukemia

FDA Approves CliniMACS CD34 Reagent System for the Prevention of Graft-vs-Host Disease in AML

The ASCO Post  / February 15, 2014

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...

Lung Cancer

Dabrafenib Receives FDA Breakthrough Therapy Designation for BRAF-Mutated NSCLC

The ASCO Post  / February 1, 2014

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...

Skin Cancer

FDA Approves Combination Therapy for Unresectable or Metastatic Melanoma With BRAF V600E/K Mutations

The ASCO Post  / February 1, 2014

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...

Issues in Oncology

Health IT Safety Guide

The ASCO Post  / February 1, 2014

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) ...

Breast Cancer

Philips Receives FDA Clearance for Spectral Breast Density Measurement Application

The ASCO Post  / January 15, 2014

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 ...

Thyroid Cancer

FDA Approves Sorafenib to Treat Late-Stage Differentiated Thyroid Cancer

The ASCO Post  / December 15, 2013

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...

Lung Cancer

FDA Grants Regular Approval to Crizotinib for ALK-Positive NSCLC

The ASCO Post  / December 15, 2013

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...

Lymphoma

FDA Approves Ibrutinib for Mantle Cell Lymphoma

The ASCO Post  / December 1, 2013

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...

Symptom Management

New Medical Device Treats Urinary Symptoms Related to Benign Prostatic Hyperplasia

The ASCO Post  / December 1, 2013

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...

Leukemia

FDA Grants Ofatumumab Breakthrough Therapy Designation for Previously Untreated CLL

The ASCO Post  / December 1, 2013

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...

Pain Management

FDA Approves First Extended-Release, Single-Entity Hydrocodone Product

The ASCO Post  / November 15, 2013

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 ...

Leukemia

Sale of Ponatinib Suspended Due to Risk of Life-Threatening Blood Clots

The ASCO Post  / November 15, 2013

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...

Gastrointestinal Cancer

FDA Grants Priority Review to Ramucirumab as a Potential Single-Agent Treatment for Advanced Gastric Cancer

The ASCO Post  / November 15, 2013

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...

Issues in Oncology

FDA Announces Strategic Plan to Prevent Drug Shortages

The ASCO Post  / November 15, 2013

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...

CNS Cancers

FDA Approves Transducer Array Layout System for Use in Patients With Recurrent Glioblastoma Multiforme

The ASCO Post  / November 15, 2013

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...

Issues in Oncology

FDA Hears Proposals on Codevelopment of Companion Diagnostics for Breakthrough Therapies

Caroline McNeil  / November 15, 2013

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...

Leukemia

FDA Approves Obinutuzumab for Chronic Lymphocytic Leukemia 

The ASCO Post  / November 15, 2013

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...

Leukemia

FDA Grants Volasertib Breakthrough Therapy Designation in AML

The ASCO Post  / November 1, 2013

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...

Pain Management

FDA Announces Class-Wide Safety Labeling Changes for Long-Acting Opioid Analgesics to Combat Abuse

The ASCO Post  / November 1, 2013

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...

Issues in Oncology
Legislation

A Look Ahead: How the FDA Is Adapting in the Era of Precision Medicine  

Jo Cavallo  / November 1, 2013

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...

Breast Cancer
Colorectal Cancer

FDA Approves First Generic Capecitabine to Treat Colorectal and Breast Cancers

The ASCO Post  / October 15, 2013

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...

Pancreatic Cancer

FDA Approves Nab-Paclitaxel for Late-Stage Pancreatic Cancer

The ASCO Post  / October 15, 2013

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...

Breast Cancer

FDA Grants Breakthrough Therapy Status to Entinostat for Advanced Breast Cancer

The ASCO Post  / October 15, 2013

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 ...

Breast Cancer

FDA Approves Neoadjuvant Pertuzumab for Early-Stage Breast Cancer

The ASCO Post  / October 15, 2013

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...

Lymphoma

FDA Approves Mechlorethamine Gel for Cutaneous T-Cell Lymphoma

The ASCO Post  / September 15, 2013

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 ...

Thyroid Cancer

Sorafenib Granted Priority Review for Differentiated Thyroid Cancer 

The ASCO Post  / September 15, 2013

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  / September 1, 2013

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 ...

Issues in Oncology

FDA Invites Public Input on Menthol in Cigarettes

The ASCO Post  / August 15, 2013

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...

Supportive Care

FDA Issues Warning on Rare but Serious Skin Reactions with Acetaminophen

The ASCO Post  / August 15, 2013

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...

Leukemia
Lymphoma

New Drug Application Submitted for Ibrutinib in the Treatment of Two B-cell Malignancies

The ASCO Post  / July 25, 2013

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...

Gynecologic Cancers

Roche Files for Cervical Cancer Primary Screening Indication for cobas HPV Test

The ASCO Post  / July 25, 2013

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...

Breast Cancer
Leukemia

FDA Grants Priority Review to Obinutuzumab in CLL and Pertuzumab in Neoadjuvant Therapy for HER2-positive Early-stage Breast Cancer

The ASCO Post  / July 25, 2013

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...

Issues in Oncology

FDA Announces Decisions on New Tobacco Products

The ASCO Post  / July 25, 2013

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...

Lung Cancer

FDA Approves Afatinib for Late-stage Lung Cancer

The ASCO Post  / July 25, 2013

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...

Issues in Oncology

Investigational New Drug Application Filed for CFI-400945

The ASCO Post  / July 10, 2013

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...

Solid Tumors

FDA Approves Denosumab to Treat Giant Cell Tumor of the Bone

The ASCO Post  / July 10, 2013

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

The ASCO Post  / July 10, 2013

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...

Breast Cancer

FDA Approves New Silicone Gel-filled Breast Implant

The ASCO Post  / June 25, 2013

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 ...

Skin Cancer

FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer

The ASCO Post  / June 25, 2013

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...

Head and Neck Cancer

SGX942 Gets Fast Track Status for Treatment of Oral Mucositis

The ASCO Post  / June 25, 2013

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...

Hematologic Malignancies

Orphan Drug Status Granted for Novel Targeted Therapy to Treat Rare Hematologic Cancer

The ASCO Post  / June 25, 2013

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...

Lymphoma

FDA Approves Lenalidomide for Relapsed/Refractory Mantle Cell Lymphoma

The ASCO Post  / June 25, 2013

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...

Issues in Oncology
Supportive Care

FDA Clears Multicenter Trial of Treatment for Hair Loss Related to Chemotherapy

The ASCO Post  / June 25, 2013

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...

Lung Cancer

FDA Approves Expanded Use for Erlotinib, Companion Diagnostic to Detect Genetic Mutations in NSCLC

The ASCO Post  / June 10, 2013

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...

Prostate Cancer

Radium-223 Dichloride Approved for Patients with Castration-resistant Prostate Cancer

The ASCO Post  / June 10, 2013

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...

Lung Cancer

Peregrine Pharmaceuticals Reaches Agreement with FDA on Phase III Trial Design for Bavituximab in NSCLC

The ASCO Post  / June 10, 2013

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...

Leukemia

Ibrutinib Receives Third Breakthrough Therapy Designation from the FDA

The ASCO Post  / May 15, 2013

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...

Skin Cancer

Breakthrough Therapy Designation for Lambrolizumab for the Treatment of Advanced Melanoma

The ASCO Post  / May 15, 2013

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

The ASCO Post  / May 15, 2013

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. ...

Issues in Oncology
Symptom Management

FDA Approves Antiemetic Drug for New Line of Prefilled Generic Injectables

The ASCO Post  / May 15, 2013

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...

Multiple Myeloma

Daratumumab Receives Breakthrough Therapy Designation in Multiple Myeloma

The ASCO Post  / May 15, 2013

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...

Issues in Oncology
Pain Management

New Labeling for Reformulated OxyContin to Curb Abuse 

Keegan Bales  / May 15, 2013

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 ...

Issues in Oncology

FDA Warns about Potential Medication Errors 

The ASCO Post  / May 15, 2013

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 

The ASCO Post  / May 1, 2013

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...

Solid Tumors

FDA Approves Assay That May Help Detect the Progression of Testicular Cancer 

The ASCO Post  / May 1, 2013

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...

Colorectal Cancer
Lymphoma

Errata

The ASCO Post  / April 15, 2013

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...

Breast Cancer
Skin Cancer

FDA Approves New Radioactive Diagnostic Imaging Agent to Help Locate Lymph Nodes in Patients with Certain Cancers

The ASCO Post  / April 15, 2013

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...

Breast Cancer

Philips Receives FDA 510(k) Clearance for MicroDose SI Mammography System

The ASCO Post  / April 15, 2013

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...

Breast Cancer

T-DM1 for HER2-positive Metastatic Breast Cancer Receives FDA Approval

The ASCO Post  / March 15, 2013

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...

Hematologic Malignancies

Ibrutinib Receives Two Oncology Breakthrough Therapy Designations from FDA

The ASCO Post  / March 15, 2013

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...

Hematologic Malignancies
Leukemia

Apogenix Receives FDA Orphan Drug Designation for APG101 to Treat Myelodysplastic Syndromes and Initiates Clinical Phase I Study

The ASCO Post  / March 15, 2013

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...

Solid Tumors

FDA Approves Regorafenib for Advanced Gastrointestinal Stromal Tumors

The ASCO Post  / March 15, 2013

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...

Multiple Myeloma

FDA Approves Pomalidomide for Advanced Multiple Myeloma

The ASCO Post  / March 1, 2013

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...

Leukemia

Imatinib Receives New Indication for Children with Acute Lymphoblastic Leukemia 

The ASCO Post  / March 1, 2013

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...

Colorectal Cancer

Bevacizumab Approved as Combination Therapy for Metastatic Colorectal Cancer after Progression on First-line Bevacizumab Therapy

The ASCO Post  / February 15, 2013

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...

Breast Cancer

Dune Medical Devices Receives FDA Approval for the MarginProbe System

The ASCO Post  / February 1, 2013

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...

Myelodysplastic Syndromes

Ezatiostat Gets Orphan Designation for Treatment of Myelodysplastic Syndrome

The ASCO Post  / February 1, 2013

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...

Leukemia

FDA Approves Ponatinib to Treat CML and Philadelphia Chromosome–positive ALL

The ASCO Post  / January 15, 2013

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...

Lymphoma

Faster Rituximab Infusion for Previously Untreated Follicular Non-Hodgkin and Diffuse Large B-cell Lymphomas 

Matthew Stenger  / January 15, 2013

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...

Prostate Cancer

New Drug Application Submitted for Radium-223 for the Treatment of Castration-resistant Prostate Cancer with Bone Metastases

The ASCO Post  / January 15, 2013

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 ...

Prostate Cancer

Elekta Receives FDA 510(k) Clearance for Clarity 4D Monitoring

The ASCO Post  / January 15, 2013

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...

Prostate Cancer

FDA Expands Abiraterone’s Use for Late-stage Prostate Cancer

The ASCO Post  / January 15, 2013

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...

Thyroid Cancer

Cabozantinib Approved for Treatment of Progressive Metastatic Medullary Thyroid Cancer

The ASCO Post  / December 15, 2012

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...

Breast Cancer

FDA Grants Fast Track Designation to Etirinotecan Pegol for the Treatment of Metastatic Breast Cancer

The ASCO Post  / December 15, 2012

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  / December 15, 2012

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...

Lung Cancer

Supplemental New Drug Application Submitted for Erlotinib as a First-line Therapy in Genetically Distinct NSCLC

The ASCO Post  / December 15, 2012

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...

Kidney Cancer

IMA901 Granted Orphan Drug Designation by FDA

The ASCO Post  / December 15, 2012

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...

Issues in Oncology

2012 In Review: Oncology Drugs/Indications Newly Approved by FDA

The ASCO Post  / December 15, 2012

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  / November 15, 2012

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  / November 15, 2012

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  / November 15, 2012

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  / November 15, 2012

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  / November 15, 2012

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  / November 15, 2012

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...

Issues in Oncology

Nab-paclitaxel Approved in First-line Metastatic NSCLC

The ASCO Post  / November 1, 2012

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 ...

Colorectal Cancer

Regorafenib Approved for Advanced Colorectal Cancer

The ASCO Post  / October 15, 2012

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...

Solid Tumors

New Drug Application Submitted for Regorafenib to Treat GIST

The ASCO Post  / October 15, 2012

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  / October 15, 2012

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...

Breast Cancer
Issues in Oncology

FDA Approves First Ultrasound Imaging System for Dense Breast Tissue

The ASCO Post  / October 15, 2012

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%...

Prostate Cancer
Issues in Oncology

FDA Approves Production of Imaging Agent to Detect Prostate Cancer

The ASCO Post  / October 15, 2012

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...

CNS Cancers

Paclitaxel Poliglumex Gets Orphan Drug Designation for Glioblastoma Multiforme

The ASCO Post  / October 15, 2012

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...

Leukemia

FDA Approves New Orphan Drug for Chronic Myelogenous Leukemia

The ASCO Post  / September 15, 2012

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...

CNS Cancers

First Drug for Children with Rare Brain Tumor Approved

The ASCO Post  / September 15, 2012

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 ...

Issues in Oncology

FDA Issues New Safety Alert on Reumofan Plus and Reumofan Plus Premium

The ASCO Post  / September 15, 2012

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...

Hepatobiliary Cancer
Skin Cancer

NDA for Chemosaturation System to Treat Melanoma in the Liver

The ASCO Post  / September 15, 2012

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...

Prostate Cancer

FDA Grants Priority Review to Supplemental New Drug Application for Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer

The ASCO Post  / September 15, 2012

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 ...

Prostate Cancer

FDA Approves New Drug for Late-stage Prostate Cancer

The ASCO Post  / September 15, 2012

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...

Leukemia

Liposomal Vincristine Approved in Acute Lymphoblastic Leukemia

The ASCO Post  / September 1, 2012

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...

Colorectal Cancer

FDA Approves Ziv-aflibercept for Metastatic Colorectal Cancer

The ASCO Post  / August 15, 2012

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 ...

Hematologic Malignancies

Biokine Therapeutics Awarded FDA Orphan Drug Designation for Mobilization of Stem Cells in Patients with Cancer

The ASCO Post  / August 15, 2012

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...

Colorectal Cancer

FDA Approves Colon-cleansing Drug for Prep Prior to Colonoscopy

The ASCO Post  / August 15, 2012

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...

Multiple Myeloma

FDA Grants Accelerated Approval to Carfilzomib for Multiple Myeloma

The ASCO Post  / August 15, 2012

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...

Breast Cancer

Everolimus Approved for Advanced Breast Cancer

The ASCO Post  / August 15, 2012

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...

Prostate Cancer

Enzalutamide Gets Priority Review for Castrate-resistant Prostate Cancer

The ASCO Post  / August 15, 2012

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...

Colorectal Cancer

FDA Approves Cetuximab plus FOLFIRI/Therascreen in Colorectal Cancer

The ASCO Post  / July 15, 2012

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

The ASCO Post  / July 15, 2012

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...

Colorectal Cancer

Regorafenib in Metastatic Colorectal Cancer

The ASCO Post  / July 15, 2012

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...

Breast Cancer

System for Breast Cancer Surgeries Gets Positive Vote

The ASCO Post  / July 15, 2012

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 ...

Prostate Cancer

Blood Test to Improve Prostate Cancer Detection

The ASCO Post  / July 15, 2012

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...

Multiple Myeloma

Novel Agent Carfilzomib Receives Positive Vote from Oncologic Drugs Advisory Committee for Use in Multiple Myeloma

The ASCO Post  / July 1, 2012

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...

Breast Cancer

FDA Approves Pertuzumab for HER2-positive Metastatic Breast Cancer

The ASCO Post  / July 1, 2012

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...

Prostate Cancer

Supplemental New Drug Application Submitted for Abiraterone

The ASCO Post  / July 1, 2012

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...

Multiple Myeloma

Drug Safety Communication Issued Regarding Lenalidomide and Risk of New Malignancies

The ASCO Post  / June 15, 2012

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

The ASCO Post  / June 15, 2012

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...

Colorectal Cancer

Aflibercept Granted Priority Review for Metastatic Colorectal Cancer

The ASCO Post  / June 15, 2012

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

The ASCO Post  / June 15, 2012

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...

Colorectal Cancer

New Drug Application Submitted for Regorafenib for the Treatment of Metastatic Colorectal Cancer

The ASCO Post  / June 15, 2012

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...

Breast Cancer

New Breast Biopsy System with Vacuum Technology Approved

The ASCO Post  / June 15, 2012

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...

Sarcoma

FDA Approves Pazopanib for Advanced Soft-tissue Sarcoma

The ASCO Post  / May 15, 2012

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...

Breast Cancer

Automated HER2 Immunohistochemical System Approved

The ASCO Post  / May 15, 2012

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 ASCO Post  / May 15, 2012

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

The ASCO Post  / May 15, 2012

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...

Solid Tumors

FDA Approves Investigational New Drug Application for Clinical Testing of Oncology Drug Candidate ME-344

The ASCO Post  / May 1, 2012

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...

Sarcoma

ODAC Offers Recommendations on Two Sarcoma Drugs

The ASCO Post  / April 15, 2012

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...

Breast Cancer

FDA Approves New Silicone Gel–filled Breast Implant

The ASCO Post  / April 15, 2012

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 ...

Leukemia

Liposomal Vincristine Receives Positive Vote from ODAC

The ASCO Post  / April 15, 2012

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 ...

Solid Tumors
Supportive Care

FDA Drug Approvals, January–April 2012

The ASCO Post  / April 15, 2012

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...

Issues in Oncology

FDA Acts to Bolster Supply of Critically Needed Cancer Drugs

The ASCO Post  / March 15, 2012

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...

Colorectal Cancer

New Colonoscopy System Cleared by FDA

The ASCO Post  / March 15, 2012

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...

Prostate Cancer

ODAC Votes against Denosumab to Delay Bone Metastasis in Men with Castration-resistant Prostate Cancer

The ASCO Post  / March 15, 2012

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...

Breast Cancer

Ki-67 Image Analysis and Digital Read Applications Cleared

The ASCO Post  / March 15, 2012

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...

Prostate Cancer

First Urine-based Molecular Test to Gauge Need for Repeat Prostate Biopsies

The ASCO Post  / March 15, 2012

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  / March 15, 2012

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...

Issues in Oncology

FDA Issues Draft Guidance on Biosimilar Product Development

The ASCO Post  / March 1, 2012

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...

Breast Cancer

Pertuzumab Gets Priority Review for Metastatic Breast Cancer

The ASCO Post  / March 1, 2012

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...

Kidney Cancer

Axitinib Receives FDA Approval in Advanced Renal Cell Carcinoma

The ASCO Post  / February 15, 2012

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...

Skin Cancer

FDA Approves Vismodegib for Basal Cell Carcinoma

The ASCO Post  / February 15, 2012

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...

Skin Cancer

Ingenol Mebutate Approved for Topical Actinic Keratosis Therapy

The ASCO Post  / February 15, 2012

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...

Symptom Management

Glucarpidase Approved to Treat Methotrexate Toxicity

The ASCO Post  / February 15, 2012

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...

Pain Management

Shared REMS Approved for all Transmucosal Immediate-release Fentanyl Products

The ASCO Post  / February 15, 2012

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...

Health-Care Policy

FDA Completes Work on Three Drug User Fee Programs

The ASCO Post  / February 15, 2012

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 ...

Hematologic Malignancies

Subcutaneous Bortezomib Approved

The ASCO Post  / February 15, 2012

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

ASCO  / February 15, 2012

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...

Gastrointestinal Cancer

FDA Approves Imatinib for Expanded Use in GIST

The ASCO Post  / February 15, 2012

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...

Kidney Cancer

ODAC Backs Axitinib for Kidney Cancer

The ASCO Post  / January 15, 2012

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...

Gynecologic Cancers

New System for Cervical Cancer Screening Approved

The ASCO Post  / January 15, 2012

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...

Solid Tumors

Investigational New Drug Application Filed for ONT-10

The ASCO Post  / January 15, 2012

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  / January 15, 2012

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...

Breast Cancer
Issues in Oncology

FDA Announces Bevacizumab Decision: Agency Will Revoke Breast Cancer Indication

The ASCO Post  / December 15, 2011

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
Issues in Oncology

Breast Cancer Experts Voice Opinion and Express ‘Disappointment’ over FDA Decision

Caroline Helwick  / December 15, 2011

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  / December 15, 2011

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...

Leukemia

New Drug Approved to Treat Acute Lymphoblastic Leukemia

The ASCO Post  / December 15, 2011

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...

Hematologic Malignancies

FDA Approves First Drug to Treat Myelofibrosis

The ASCO Post  / December 15, 2011

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...

Solid Tumors

510(k) Clearance Granted for OncoTrac

The ASCO Post  / December 15, 2011

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...

Gynecologic Cancers

FDA Approves Molecular Test to Detect HPV

The ASCO Post  / November 15, 2011

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...

Solid Tumors

VGX-100 Investigational New Drug Application Approved

The ASCO Post  / November 15, 2011

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...

Leukemia

Test for AML Prognosis Cleared by FDA

The ASCO Post  / November 15, 2011

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...

Head and Neck Cancer

FDA Approves Cetuximab to Treat Metastatic Head and Neck Cancer

The ASCO Post  / November 15, 2011

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...

Breast Cancer

FDA Commissioner Announces Decision on Bevacizumab

The ASCO Post  / November 15, 2011

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...

Leukemia

FDA Issues Safety Announcement on Dasatinib

The ASCO Post  / November 1, 2011

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...

Issues in Oncology

Gel for Blood Vessel Surgery Approved

The ASCO Post  / November 1, 2011

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...

Issues in Oncology

Bevacizumab Labeling Revised to Include New Risks

The ASCO Post  / November 1, 2011

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...

Prostate Cancer

FDA Approves Denosumab to Increase Bone Mass in Patients with Cancer

The ASCO Post  / October 15, 2011

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...

Gynecologic Cancers

New Biomarker Test Cleared to Evaluate Ovarian Cancer Likelihood

The ASCO Post  / October 15, 2011

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...

Lymphoma

FDA Approves Brentuximab Vedotin in Two Lymphoma Indications

Matthew Stenger  / September 15, 2011

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...

Skin Cancer

Novel BRAF Inhibitor Receives FDA Approval in Metastatic Melanoma

Caroline Helwick  / September 15, 2011

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...

Pancreatic Cancer

FDA Grants Orphan Drug Status to MM-398, a Nanotherapeutic Encapsulation of Irinotecan, to Treat Pancreatic Cancer

The ASCO Post  / September 15, 2011

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...

Prostate Cancer

Action Date Set for Denosumab Supplemental Application

The ASCO Post  / September 15, 2011

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...

Leukemia

FDA Clears Genetic FISH Panel for Leukemia Patient Prognosis

The ASCO Post  / September 15, 2011

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...

Prostate Cancer

Radium-223 Chloride Gets Fast Track Designation

The ASCO Post  / September 15, 2011

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...

Lung Cancer

Crizotinib plus Companion Diagnostic Test Approved in NSCLC

The ASCO Post  / September 15, 2011

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...

Bladder Cancer

Updated Drug Label Approved for Pioglitazone after Safety Review

The ASCO Post  / September 1, 2011

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...

Issues in Oncology

FDA Issues Guidance for Diagnostic Tests Used with Targeted Therapies

The ASCO Post  / August 15, 2011

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 ...

Lymphoma

ODAC Recommends Accelerated Approval for Brentuximab

The ASCO Post  / August 15, 2011

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)....

Prostate Cancer

New Safety Information Reported for 5-alpha Reductase Inhibitors

The ASCO Post  / August 15, 2011

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...

Issues in Oncology

FDA Outlines Oversight of Mobile Medical Applications

The ASCO Post  / August 15, 2011

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...

Prostate Cancer

Final Decision on Sipuleucel-T

The ASCO Post  / July 15, 2011

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...

Breast Cancer

ODAC Again Recommends FDA Withdraw Its Approval of Bevacizumab for Metastatic Breast Cancer

The ASCO Post  / July 15, 2011

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...

Pain Management

First Fentanyl Nasal Spray Approved for Cancer Breakthrough Pain

The ASCO Post  / July 15, 2011

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 ASCO Post  / July 15, 2011

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...

Breast Cancer

Test Approved to Help Determine Candidacy for Trastuzumab

The ASCO Post  / July 1, 2011

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...

Skin Cancer

Changes Introduced to Better Inform Consumers about Sunscreen

The ASCO Post  / July 1, 2011

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...

Skin Cancer

New Drug Application Submitted for Vemurafenib in Melanoma

The ASCO Post  / June 15, 2011

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...

Pancreatic Cancer

FDA Approves Sunitinib for Pancreatic Neuroendocrine Tumors

The ASCO Post  / June 15, 2011

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...

Gynecologic Cancers

Trabectedin New Drug Application Withdrawn

The ASCO Post  / June 15, 2011

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 ASCO Post  / June 15, 2011

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...

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