First EC approval for immuno-oncology drug in specific bladder cancer indication

The European Commission (EC) has approved Opdivo (nivolumab) for the treatment of locally-advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy.

Friday’s decision makes US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo the first immuno-oncology agent approved in the European Union for the treatment of patients with this common type of bladder cancer. Opdivo is now approved in the European Union for eight indications in six distinct tumor types.

“Bladder cancer has an estimated 151,000 new cases diagnosed annually in Europe, yet there have been few advancements in treatment for advanced bladder cancer during the last few decades,” said Prof Dr Margitta Retz, Director of the Division Uro-Oncology of the Department of Urology, Technical University Munich, Germany. “The European Commission’s approval of nivolumab marks a significant advancement, with a notable objective response rate, and provides an important option to help patients with previously treated locally advanced unresectable or metastatic urothelial cancer,” she added.