Bristol-Myers: EMA To Review Opdivo Plus Yervoy In Expanded Indications

(RTTNews) - Bristol-Myers Squibb Company (BMY) announced the European Medicines Agency validated its type II variation application, which seeks to expand the current indications for Opdivo (nivolumab) plus Yervoy (ipilimumab) to include the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma. This confirms the beginning of the EMA's centralized review process.

The application is based on data from the phase 3 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.