Posted by Michael Wonder on 21 Oct 2016
U.S. FDA accepts for priority review the supplemental biologics license application for Opdivo (nivolumab) in previously treated patients with advanced form of bladder cancer
21 October 2016 - Submission based on results from Phase 2 study CheckMate-275 evaluating Opdivo in patients with previously treated platinum-refractory metastatic urothelial carcinoma.
Bristol-Myers Squibb Company announced today that the U.S. FDA accepted a supplemental biologics license application, which seeks to expand the use of Opdivo to patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) that has progressed on or after platinum-containing therapy.
The FDA granted the application priority review and previously granted Opdivo breakthrough therapy designation for mUC in June 2016, reinforcing the need for new treatment approaches in this patient population.
The FDA action date is 2 March 2017.
