BMS' Opdivo scores eighth approval in Europe for bladder cancer

The decision, which now makes Opdivo the first and only immuo-oncology agent approved in the treatment of this type of bladder cancer within Europe, was based on Phase 2 findings showing that 20% of 270 participants responded to treatment with the drug, with 3% registering a complete response and 17% a partial response, meeting its endpoint of objective response.

However, despite this, 17.8% of participants experienced a grade 3 or 4 adverse event as a result of treatment, and four patients died due to treatment-related pneumonitis or cardiovascular failure.

"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," explained 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."

BMS’ Murdo Gordon, Executive Vice President and Chief Commercial Officer, also added: "We are pleased with the European Commission’s approval of Opdivo for patients with previously treated locally advanced unresectable or metastatic urothelial carcinoma, many of whom have been in need of an additional treatment option. With this second EU approval for Opdivo in as many months, Bristol-Myers Squibb is demonstrating our commitment to help address unmet needs for cancer patients. We intend to work closely with EU health authorities to make Opdivo available for patients with this common form of bladder cancer as soon as possible."