Merck Receives FDA Approval for Keytruda as First-Line Treatment for MSI-H Colorectal Cancer

Merck today announced that the FDA has approved KEYTRUDA (pembrolizumab) as first-line treatment for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). In the Phase 3 KEYNOTE-177 trial, KEYTRUDA demonstrated a statistically significant improvement in progression-free survival compared to chemotherapy. The median PFS was 16.5 months for KEYTRUDA versus 8.2 months for chemotherapy. This approval establishes KEYTRUDA as the preferred first-line treatment for patients with MSI-H/dMMR CRC, a subset of colorectal cancer that responds particularly well to immunotherapy.