FDA Approves Opdivo Plus Yervoy Combo For HCC Patients Previously Treated with Sorafenib

On March 11, 2020, Bristol Myers-Squibb announced that the U.S. Food and Drug Adminstration (FDA) has approved Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) to treat hepatocellular carcinoma (HCC) 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.

Read the corporate announcement.

Posted 3/11/2020