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 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.