Opdivo plus Yervoy gets Priority Review for RCC

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted and granted Priority Review to an sBLA for Opdivo nivolumab plus Yervoy ipilimumab to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The PDUFA date is April 16.

BMS said the application is based on results of the Phase III CheckMate -214 trial, in which the combo met the co-primary endpoints of improving overall survival (OS) and objective response rate (ORR) compared with Sutent sunitinib from Pfizer Inc. (NYSE:PFE). Opdivo plus Yervoy missed a third co-primary endpoint evaluating progression-free survival (PFS). The combo has breakthrough therapy designation for the indication (see BioCentury, Sept. 8)...