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【FDA Approval Alert】Bristol Myers Squibb’s nivolumab + ipilimumab Approved for Advanced Hepatocellular Carcinoma (April 11, 2025)
On April 11, 2025, the U.S. FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). Approval was based on results from the CHECKMATE-9DW trial (NCT04039607).
Disease Overview: Advanced Hepatocellular Carcinoma (HCC)
HCC is the most common form of primary liver cancer. For advanced cases, immunotherapy and targeted agents are standard options. Preserved liver function (Child Pugh A) is typically required.
Treatment Summary
- Drug Name: nivolumab (Opdivo) + ipilimumab (Yervoy)
- Company: Bristol Myers Squibb Company
- Approval Date: April 11, 2025
- Indication: First-line treatment of unresectable or metastatic HCC
- Mechanism of Action: PD-1 and CTLA-4 immune checkpoint inhibition
- Pivotal Trial: CHECKMATE-9DW (NCT04039607)
- Key Efficacy:
- Overall Survival (OS): 23.7 vs 20.6 months (HR 0.79; p<0.0180)
- Overall Response Rate (ORR): 36.1% vs 13.2% (p<0.0001)
Patient-Friendly Summary
The Opdivo + Yervoy combination boosts the immune system to attack cancer cells, offering a new first-line option for patients with advanced liver cancer.
M&A Information
- Subsidiary: Not applicable (Bristol Myers Squibb in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (NYSE: BMY)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
