Posted by Michael Wonder on 11 Nov 2019
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) combination for patients with previously treated advanced hepatocellular carcinoma
11 November 2019 - The FDA also granted Opdivo plus Yervoy Breakthrough Therapy Designation for this potential indication.
Bristol-Myers Squibb today announced that the U.S. FDA has accepted its supplemental biologics license application and granted breakthrough therapy designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib.
The FDA granted the application priority review with a Prescription Drug User Fee Act goal date of 10 March 2020.
