Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted for filing and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
The sBLA submission is based on results from the Phase 3 study, CheckMate -025, which evaluated the overall survival of Opdivo in patients with previously treated advanced RCC vs. the current standard of care, everolimus. CheckMate -025 was stopped early in July 2015 due to the study meeting its primary endpoint of overall survival. Detailed results were presented at the 2015 European Cancer Congress and published in The New England Journal of Medicine.
The FDA previously granted Opdivo Breakthrough Therapy designation for the treatment of patients with advanced RCC who have received prior therapy. The projected FDA action date is March 16, 2016.
Opdivo is the first ever PD-1 immune checkpoint inhibitor to receive regulatory approval, including indications for metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, and unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
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