30 April 2021 - Application based on Phase 3 CheckMate-274 trial, in which Opdivo nearly doubled disease-free survival compared to placebo.
BMS today announced that the U.S. FDA has accepted the supplemental biologics license application for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma, based on results from the CheckMate-274 trial.
The FDA granted the application priority review and assigned a Prescription Drug User Fee Act goal date of 3 September 2021.