Posted by Michael Wonder on 28 Nov 2017
European Medicines Agency validates Bristol-Myers Squibb’s Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in intermediate and poor-risk patients with advanced renal cell carcinoma
28 November 2017 - Application is based on results from the Phase 3 CheckMate-214 study.
Bristol-Myers Squibb Company today announced that the EMA 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.
Validation of the application confirms the submission is complete and begins the EMA’s centralised review process.
