FDA accepts for priority review the sBLA for Opdivo in patients with advanced renal cell carcinoma

The projected FDA action date is 16 March 2016.

Michael Giordano, senior vice president, head of Oncology Development, BMS, commented: “There remains a significant unmet medical need for advanced renal cell carcinoma patients who have received prior therapy and are often repeatedly treated with agents that are similar in mechanism. We are pleased the FDA has accepted our sBLA for Opdivo in RCC, and we will continue to work with urgency to bring Opdivo to patients with this cancer.”

This sBLA submission is based on CheckMate -025, a Phase III study that evaluated the overall survival of Opdivo in patients with previously treated advanced RCC versus everolimus, a current standard of care in this patient population. The trial was stopped early in July 2015 because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint of overall survival. Data from CheckMate -025 were recently presented at the 2015 European Cancer Congress and simultaneously published in The New England Journal of Medicine.