Opdivo/Yervoy combo under 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, 2018.

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. 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 Extra, Sept. 7)...