Posted by Michael Wonder on 05 Dec 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
5 December 2023 - The US FDA assigned a target action date of 5 April 2024.
BMS today announced that the US FDA has accepted the supplemental biologics license application for Opdivo (nivolumab) 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.
