Posted by Michael Wonder on 20 Sep 2016
European Medicines Agency validates Bristol-Myers Squibb’s type II variation application for Opdivo (nivolumab) in advanced form of bladder cancer
20 September 2016 - Results from Phase II study CheckMate-275 evaluating Opdivo in metastatic urothelial carcinoma serve as basis for application.
Bristol-Myers Squibb Company announced today that the EMA validated its type II variation application, which seeks to extend the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
