> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA OKs Opdivo + Yervoy in Liver Cancer
- URL: https://www.fdaweb.com/fda-oks-opdivo-yervoy-in-liver-cancer/
- Published: 2025-04-11T12:00:00.000Z
- Updated: 2026-09-14T14:57:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158995

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

Approval was based on data from the CHECKMATE-9DW (NCT04039607) trial in 668 adults with unresectable or metastatic HCC. The primary efficacy outcome measure was overall survival (OS) — median OS was 23.7 months in the nivolumab plus ipilimumab arm and 20.6 months in the lenvatinib or sorafenib arm, an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma?utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

The most common adverse reactions (>20%) were rash, pruritus, fatigue, and diarrhea, the agency adds.