Opdivo is the first and only Immuno-Oncology agent to receive European approval for the treatment of this type of bladder cancer
Opdivo is now approved in the European Union for eight indications in six distinct tumor types
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 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. Today’s decision makes Opdivo the first Immuno-Oncology agent approved in the European Union for the treatment of patients with this common type of bladder cancer.
“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.”
The approval was based on results from CheckMate -275, a Phase 2, open-label, single-arm, multicenter study evaluating Opdivo in patients with locally advanced or mUC who have disease progression during or following treatment with a platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. In this study, 270 patients received Opdivo 3 mg/kg administered intravenously every two weeks until disease progression or unacceptable toxicity. The primary endpoint of the trial was objective response rate (ORR). Secondary endpoints included progression free survival (PFS) and overall survival (OS). In the trial, 20.0% (95% CI: 15.4, 25.3; 54/270) of patients responded to treatment with Opdivo. The percentage of patients with a complete response was 3.0% (8/270) and the percentage of patients with a partial response was 17% (46/270).
