Posted by Michael Wonder on 24 May 2017
U.S. Food and Drug Administration accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) in previously treated hepatocellular carcinoma
24 May 2017 - Application is based on results from the Phase 1/2 CheckMate-040 trial.
Bristol-Myers Squibb Company today announced that the U.S. FDA accepted a supplemental biologics license application that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC) after prior sorafenib therapy.
The FDA granted the application priority review and previously granted Opdivo orphan-drug designation for the treatment of HCC.
The FDA action date is 24 September 2017.
