EMA validates application for Opdivo (nivolumab) to treat metastatic urothelial carcinoma (mUC).(bladder cancer)- BMS

Bristol-Myers Squibb Company announced that the European Medicines Agency (EMA) validated its type II variation application, which seeks to extend the current indications for Opdivo (nivolumab) to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) 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.

The application included data from CheckMate -275, a Phase II, open-label, single-arm study assessing the safety and efficacy of Opdivo in patients with locally advanced unresectable or mUC that has progressed after a platinum-containing therapy. The primary endpoint in CheckMate -275 trial is objective response rate, and additional efficacy measures included durability of response and overall survival.Data presented at American Society of Clinical Oncology meeting earlier this year 2016 showed an objective response rate of 24.4 percent.