FDA Approves Opdivo for Bladder Cancer

FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) injection, for intravenous use for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months after neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The indication was approved under accelerated approval based on tumor response rate and duration of response.

In the CheckMate-275 trial, 19.6% of patients responded to treatment with Opdivo, according to the company. “The percentage of patients with a complete response was 2.6% (7/270) and the percentage of patients with a partial response was 17% (46/270),” it says.

Opdivo is also approved for treating certain patients with melanoma, non-small cell lung cancer, advanced renal cell carcinomam, Hodgkin lymphoma, and squamous cell carcinoma of the head and neck.