CHMP says no to Opdivo + Yervoy for RCC

Bristol-Myers Squibb Co. (NYSE:BMY) revealed in its 2Q18 earnings call that EMA's CHMP plans to issue a negative opinion for Opdivo nivolumab plus Yervoy ipilimumab as first-line treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma.

In November, the European Commission accepted for review an application to extend the combination's indications to include first-line RCC. The application was based on data from the Phase III CheckMate -214 trial, which was stopped early after the combination met the trial's co-primary endpoint of improving overall survival (OS) vs. Sutent sunitinib in intermediate- and poor-risk RCC patients...