Bristol-Myers Squibb (BMY) Says EMA Validated Opdivo Type 2 Variation App for Bladder Cancer

September 20, 2016 7:07 AM EDT

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Bristol-Myers Squibb Company (NYSE: BMY) announced 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.

“The high frequency of metastatic urothelial carcinoma and its relapsing nature highlight the substantial need for new treatment approaches with high and durable responses,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “We look forward to working with the EMA to potentially extend the use of Opdivo and bring the science of Immuno-Oncology to help patients in Europe fight this difficult-to-treat, advanced form of bladder cancer.”

The application primarily included data from CheckMate -275, a Phase 2, 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 from this study will be presented at the 2016 European Society for Medical Oncology Congress.

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