Posted by Michael Wonder on 16 Oct 2017
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) in patients with resected high-risk advanced melanoma and grants priority review
16 October 2017 - Application based on results from Phase 3 CheckMate-238 study.
Bristol-Myers Squibb announced today that the U.S. FDA has accepted for priority review its supplemental biologics license application for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.
The FDA also previously granted breakthrough therapy designation for this application, which is the seventh indication for which Opdivo has received this designation.
