FDA Approvals, News & Updates
- Keytruda Receives Accelerated Approval for Relapsed/Refractory Classical Hodgkin Lymphoma
- Kisqali, a New CDK4/CDK6 Inhibitor, Approved as First-Line Therapy for HR-Positive, HER2-Negative Advanced Breast Cancer
- Xermelo First Oral Treatment Approved for Carcinoid Syndrome Diarrhea in Patients with NETs
- Revlimid Approved as Maintenance Therapy for Multiple Myeloma After Autologous Stem-Cell Transplantation
- Opdivo Now Approved for Advanced or Metastatic Bladder Cancer
- Imbruvica First Nonchemotherapy Drug Approved for Relapsed/Refractory Marginal Zone Lymphoma
- Rubraca a New Treatment Option for Patients with Advanced Ovarian Cancer
On December 19, 2016, the FDA granted accelerated approval to rucaparib (Rubraca; Clovis Oncology Inc), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation, and who have been treated with ≥2 chemotherapies.
- Rubraca Approved for Advanced Ovarian Cancer with BRCA Mutations
- Avastin Approved for Platinum-Sensitive Ovarian Cancer
- Darzalex Approved for Use in Combination with Standard Regimen for Multiple Myeloma
- Opdivo Now Approved for Head and Neck Squamous-Cell Carcinoma
The FDA has granted accelerated approval of rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation and have been treated with ≥2 chemotherapies. The administration also approved a companion diagnostic to the drug, FoundationFocus CDxBRCA, which is the first next-generation sequencing diagnostic test.
The FDA has granted approval to daratumumab (Darzalex) for the treatment of patients with multiple myeloma who have received ≥1 previous therapies, in combination with dexamethasone and either lenalidomide or bortezomib.
On August 10, 2016, the FDA approved granisetron extended-release (Sustol; Heron Therapeutics) injection, the first extended-release 5-hydroxytryptamine (5-HT3) receptor antagonist, in combination with other antiemetic drugs in adults.
On April 25, 2016, the FDA approved cabozantinib (Cabometyx; Exelixis) for the treatment of patients with advanced renal-cell carcinoma (RCC) who had received anti-angiogenic therapy.
- Tecentriq First PD-L1 Approved by the FDA for Metastatic NSCLC
- Keytruda Receives New Indication for First-Line Treatment of Metastatic NSCLC
- Lartruvo Approved for Soft-Tissue Sarcoma
On October 18, 2016, atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, was approved by the FDA for patients with metastatic non–small-cell lung cancer (NSCLC) associated with the EGFR or ALK genetic mutations whose disease progressed during or after treatment with platinum-containing chemotherapy.
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Results 31 - 40 of 134
Results 31 - 40 of 134