FDA Approves Opdivo Plus Yervoy as First-Line Treatment for MSI-H/dMMR Unresectable or Metastatic Colorectal Cancer

The U.S. Food and Drug Administration has approved Bristol Myers Squibb’s Opdivo (nivolumab) combined with Yervoy (ipilimumab) as a first-line treatment 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. This approval is based on the Phase 3 CheckMate-8HW trial, which showed the combination significantly reduced the risk of disease progression or death.

In the first-line setting, the Opdivo-Yervoy regimen reduced progression risk by 79% versus chemotherapy. Across all lines of therapy, it showed a 38% reduction compared to Opdivo alone. Notably, median progression-free survival (PFS) was not reached in the combination group, while it was 5.8 months with chemotherapy. The approval was granted more than two months ahead of the expected FDA decision date.

The combination also demonstrated a higher overall response rate (71%) compared to Opdivo monotherapy (58%), with a manageable safety profile and no new safety concerns identified. Serious adverse reactions occurred in 46% of patients on the combination regimen, with common side effects including fatigue, diarrhea, and pruritus.

Colorectal cancer remains one of the most diagnosed cancers in the U.S., with increasing incidence among younger adults. Approximately 7% of patients with metastatic colorectal cancer have MSI-H/dMMR tumors, which often respond poorly to standard chemotherapy.

This marks the ninth gastrointestinal cancer indication for Opdivo-based therapy. It expands the prior accelerated approval of Opdivo plus Yervoy from second-line to first-line treatment for MSI-H/dMMR metastatic colorectal cancer.

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