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FDA Approves Opdivo + Yervoy For Patients With Hepatocellular Carcinoma Previously Treated With Sorafenib

Bristol Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) to

Benzinga · 03/11/2020 11:07

Bristol Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.1,2 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.1,2,3 Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1,2