Posted by Michael Wonder on 11 Mar 2020
U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) for patients with hepatocellular carcinoma previously treated with sorafenib
11 March 2020 - Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting.
Bristol Myers Squibb today announced that Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) was approved by the U.S. FDA to treat hepatocellular carcinoma in patients who have been previously treated with sorafenib.
Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response seen in the Opdivo + Yervoy cohort of the Phase 1/2 CheckMate-040 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
