【FDA Approval Alert】Bristol Myers Squibb’s nivolumab + ipilimumab Approved for MSI-H/dMMR Colorectal Cancer (April 8, 2025)
On April 8, 2025, the U.S. FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) for adults and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). Concurrently, nivolumab monotherapy for previously treated metastatic MSI-H/dMMR CRC was converted from accelerated to regular approval. Approval was based on results from the CHECKMATE-8HW trial (NCT04008030).
Disease Overview: MSI-H/dMMR Colorectal Cancer
MSI-H/dMMR CRC is a molecular subtype characterized by defective DNA mismatch repair, associated with high response to immunotherapy and sometimes with hereditary syndromes.
Treatment Summary
- Drug Name: nivolumab (Opdivo) + ipilimumab (Yervoy)
- Company: Bristol Myers Squibb Company
- Approval Date: April 8, 2025
- Indication: Unresectable/metastatic MSI-H/dMMR CRC (≥12 years)
- Mechanism of Action: PD-1 and CTLA-4 checkpoint inhibition
- Pivotal Trial: CHECKMATE-8HW (NCT04008030)
- Key Efficacy:
- First-line: Median PFS not reached vs 5.8 months (HR 0.21; p<0.0001)
- All lines: Median PFS NR vs 39.3 months (HR 0.62; p=0.0003), ORR 71% vs 58%
Patient-Friendly Summary
The Opdivo + Yervoy combination activates immune responses, showing high efficacy for DNA mismatch repair-deficient colorectal 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.
