Bristol-Myers Squibb’s Opdivo has picked up approval for its eighth indication in Europe, having won clearance for the treatment of a subset of patients with metastatic urothelial carcinoma (mUC).

The European Commission is allowing the drug’s use to treat adults with locally advanced unresectable or mUC after failure of prior platinum-containing therapy, making it the only immuno-oncology agent available in the region for this 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 decision was based on data from the Phase II CheckMate -275 trial, in which 20 percent of patients responded to treatment with Opdivo, a PD-1 immune checkpoint inhibitor, including 3 percent who experienced a complete response.

The response rate was 25 percent in patients with tumour PD-L1 expression ≥1 percent and 15.8 percent in those with tumour PD-L1 expression <1 percent.

Among the 270 patients who received the drug in the trial, 17.8 percent experienced a grade 3 or 4 treatment-related adverse event (AE). Overall, 4.8 percent of patients discontinued therapy due to treatment-related AEs of any grade, and 3.0 percent discontinued therapy due to grade 3-4 treatment-related AEs, while treatment-related death occurred in four patients due to pneumonitis or cardiovascular failure, the firm noted.

Bladder cancer is the fifth most common cancer in Europe, with an estimated 151,000 new cases diagnosed per year and over 52,000 deaths per year. Urothelial carcinoma is the most common type, accounting for around 90 percent of cases.

“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,” said Murdo Gordon, executive vice president and chief commercial officer, BMS.