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# Opdivo sBLA for Bladder Cancer
- URL: https://www.fdaweb.com/opdivo-sbla-for-bladder-cancer/
- Published: 2023-12-06T12:00:00.000Z
- Updated: 2026-09-14T14:17:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155935

FDA has accepted for priority review a Bristol Myers Squibb (BMS) supplemental BLA for Opdivo (nivolumab) for combination use with cisplatin-based chemotherapy for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (bladder cancer). The agency has set a user fee review action target date of 4/5/2024.

The submission is based on data from the Phase 3 CheckMate-901 trial which showed the combination had a “statistically significant and clinically meaningful survival benefit over standard-of-care gemcitabine plus cisplatin in the patient population,” according to BMS. *“*Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR).”

BMS says the safety profile was “tolerable and consistent” with previous safety profiles of the regimen’s individual components, adding that no new safety concerns were identified.

Opdivo is described as a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to activate the body’s own immune system to help restore anti-tumor immune response. It is currently approved as a treatment option across multiple cancers, such as melanoma, non-small cell lung cancer, mesothelioma, and renal cell carcinoma, among others.