EMA Validates Bristol-Myers Squibb’s Type II Variation Application For Opdivo (nivolumab) In Advanced Form Of Bladder Cancer

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the European Medicines Agency (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 (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.
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