FDA Approves Opdivo With Yervoy for Unresectable or Metastatic Hepatocellular Carcinoma

The FDA has approved nivolumab (Opdivo, Bristol Myers Squibb) with ipilimumab (Yervoy, Bristol Myers Squibb) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).

Efficacy was evaluated in CheckMate 9DW (ClinicalTrials.gov Identifier: NCT04039607), a randomized (1:1), open-label trial in 668 adults with unresectable or metastatic HCC. Patients had histologically confirmed HCC, a Child-Pugh class A score, ECOG Performance Status 0 or 1, and