BMS Earns FDA Approval for Opdivo and Yervoy for Liver Cancer
The FDA granted accelerated approval to Bristol-Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
The approval was based on the response rate and duration of response in a clinical trial. The agency said that continued approval would depend on the results of confirmatory trials.
The FDA previously granted a breakthrough therapy designation for the indication.