FDA Issues Warnings to Fraudulent Cancer Treatment Companies
On April 25, 2017, the U.S. Food and Drug Administration (FDA) issued warning letters to 14 companies that were selling fraudulently marketed products claiming to prevent, diagnose, treat, or cure cancer. In total, the companies produced more than 65 products that have been sold in the United States without FDA approval.
GOP to Potentially Revisit Healthcare Legislation; New State Funding Will Combat Opioid Epidemic; FDA Reaches Reauthorization Fee Deal for New Drugs, Devices
As the first 100 days of the Trump administration ends, the White House is still pressing Congress to revisit healthcare legislation—one of Trump’s main campaign promises.
FDA Approves Marketing of First Digital Pathology Whole Slide Imaging System
The U.S. Food and Drug Administration (FDA) has permitted marketing of the Philips IntelliSite Pathology Solution (PIPS, Philips Medical Systems Nederland B.V.), as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue.
FDA Removes Risk Evaluation Management Strategies (REMS) for ESAs
On April 13, 2017, the U.S. Food and Drug Administration (FDA) removed the Risk Evaluation and Mitigation Strategy (REMS) requirements for the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy.
FDA Approves Marketing Ipsogen JAK2 RGQ PCR Kit to Help Evaluate Suspected Polycythemia Vera
The U.S. Food and Drug Administration has granted marketing authorization to ipsogen JAK2 RGQ PCR Kit, manufactured by Qiagen GmbH., to detect mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV).
FDA Broadens Palbociclib Indication in Breast Cancer
On March 31, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to palbociclib for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women.
FDA Grants Regular Approval to Osimertinib for EGFR T790 Mutation-Positive NSCLC
On March 30, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to osimertinib for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
Recent FDA-Approved Drugs Offer More Options for NSCLC and Other Cancers
The end of 2016 proved to be a busy and exciting time for cancer breakthroughs, seeing eight new U.S. Food and Drug Administration (FDA) approvals for immunotherapy and biotherapy. Following is a summary of cancer-related FDA approvals in the last quarter of 2016, indications for treatment, and associated clinical implications.
FDA Approves Niraparib for Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On March 27, 2017, the U.S. Food and Drug Administration (FDA) approved niraparib, a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
FDA Approves Avelumab for Treatment of Patients With Metastatic Merkel Cell Carcinoma
On March 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio, EMD Serono, Inc.) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer.
FDA Approves Pembrolizumab for Refractory or Relapsed Classical Hodgkin Lymphoma
On March 14, 2017, The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.
FDA Approves Ribociclib for Breast Cancer Treatment
On March 13, 2017, the U.S. Food and Drug Administration (FDA) approved ribociclib (KISQALI®, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
FDA Announces Oncology Center of Excellence
The U.S. Food and Drug Administration (FDA) recently announced, through the Office of Health and Constituent Affairs, that it has established the Oncology Center of Excellence (OCE). Longtime FDA official, Richard Pazdur, MD, has been named to lead the division as its first director. The OCE 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,” according to the FDA.
FDA Approves Xermelo for Carcinoid Syndrome Diarrhea
The U.S. Food and Drug Administration (FDA) today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled.
FDA Approves Lenalidomide as Maintenance Therapy for Patients With Multiple Myeloma
On February 22, 2017, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid®, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.
FDA Approves Nivolumab for Advanced or Metastatic Bladder Cancer
On February 2, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.
FDA Approves Rucaparib for Advanced Ovarian Cancer
FDA Approves Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy
FDA Approves Nivolumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
FDA Approves Pembrolizumab for Treatment of Non-Small Cell Lung Cancer
FDA Approves Olaratumab for Soft Tissue Sarcoma
FDA Approves Atezolizumab for Advanced Non-Small Cell Lung Cancer
FDA Modifies Use of Erlotinib in NSCLC, Used Only in Patients With EGFR Tumor Mutations
FDA Issues Warning Letters for the Sale of Tobacco to Minors
Thyroid Cancer Treatment’s Changing Landscape Brings New Hope to Patients
FDA Modifies Nivolumab Dosing for Three Indications
An Oncology Nursing Overview of New Immune Checkpoint Inhibitors
FDA Recommends Against Ovarian Cancer Screening Tests
FDA Approves Pembrolizumab for Head and Neck Squamous Cell Carcinoma
FDA Offers Expanded Access to Patients in Need of Treatment
FDA Allows Marketing for First Nucleic Acid-Based Quantitation Test for Use During Treatment CML
Cancer Moonshot Has Designee at FDA for Agency Coordination
FDA Announces Federal Regulations of E-Cigarettes
FDA Approves Atezolizumab in Advanced or Metastatic Urothelial Carcinoma
FDA Approves Nivolumab for Classical Hodgkin Lymphoma
FDA Approves Lenvatinib Plus Everolimus in Renal Cell Carcinoma
FDA Approves Cabozantinib for Renal Cell Cancer
FDA Warns About Opioid Pain Medication and Requires Label Changes
Capitol Hill Roundup: FDA Releases Draft Guidelines for Biosimilars; Cancer Moonshot Launches Online Engagement Platform; PQLC's Virtual Lobby Day
FDA Approves Venetoclax for CLL
FDA Approves Defibrotide Sodium for Hepatic Veno-Occlusive Disease
FDA Approves Crizotinib for ROS1-Positive Lung Cancer
Innovative Clinical Trial Designs Lead to New Drug Approvals
FDA Approves New Indication for Everolimus
FDA Approves New Indication for Obinutuzumab
On February 26, 2016, the U. S. Food and Drug Administration approved obinutuzumab (Gazyva® Injection, Genentech, Inc.) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Obinutuzumab was previously approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.