FDA News & Updates

Following a year in which approximately 2 dozen cancer drugs were approved by the FDA, approvals in 2016 decreased by approximately 50% compared with 2015.
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.
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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