Posted by Michael Wonder on 23 Sep 2017
Bristol-Myers Squibb’s Opdivo (nivolumab) receives FDA approval for the treatment of hepatocellular carcinoma patients previously treated with sorafenib
22 September 2017 - The CheckMate -040 pivotal study evaluated Opdivo in patients with and without active Hepatitis B or C infection, and across PD-L1 expression levels.
Bristol-Myers Squibb today announced the U.S. FDA has approved Opdivo (nivolumab) injection for intravenous use for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
In the CheckMate -040 trial, 14.3% (95% CI: 9.2-20.8; 22/154) of patients responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% (3/154) and the percentage of patients with a partial response was 12.3% (19/154). Among responders (n=22), responses ranged from 3.2 to 38.2+ months; 91% of those patients had responses of six months or longer and 55% had responses of 12 months or longer.
