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# FDA Approves Opdivo for Bladder Cancer
- URL: https://www.fdaweb.com/fda-approves-opdivo-for-bladder-cancer/
- Published: 2017-02-06T12:00:00.000Z
- Updated: 2026-09-14T22:04:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137905

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.