Priority review granted for Opdivo

Bristol-Myers Squibb Company announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for this application, which is the 2nd indication for which the Opdivo plus Yervoy combination has received this designation. The application is based on data from the phase III CheckMate -214 study, which was stopped early based on the recommendation of an independent Data Monitoring Committee following a planned interim analysis of overall survival. The results of the study were recently presented at the European Society for Medical Oncology (ESMO) 2017 Congress. Breakthrough Therapy Designation is an FDA program intended to expedite the development and review of medicines with signals of potential clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible. The application has an action date of April 16, 2018.