Bristol Myers says FDA accepts Opdivo combo sBLA for priority review

Bristol Myers Squibb announced that the U.S. Food and Drug Administration has accepted the supplemental Biologics License Application, or sBLA, for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate -901 trial. The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act, or PDUFA, goal date of April 5, 2024. “The FDA’s acceptance of our application for Opdivo in combination with cisplatin-based chemotherapy represents important progress toward addressing the unmet need for options that may offer durable responses and improved survival for patients with metastatic urothelial carcinoma. There remains a clear need for efficacious first-line treatment options that may potentially help improve outcomes for patients with this hard-to-treat disease. We look forward to working with the FDA throughout the review of this application and hope to bring the first immunotherapy-chemotherapy combination to these patients in the U.S. We want to offer a special thanks to the patients and investigators involved in the CheckMate -901 clinical trial,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb.