Merck’s blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) has been given a nod by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for first-line treatment of adults with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

The European Commission will now consider the committee’s recommendation for a change to the drug’s existing marketing authorization. 

“Patients in Europe with MSI-H/dMMR colorectal cancer have had only chemotherapy-containing regimens available to them in the first-line treatment setting and have historically faced poor outcomes,” said Vicki Goodman, Merck Research Laboratories’ vice president of clinical research. “This positive EU CHMP opinion reinforces the potential of Keytruda as a new option for patients with MSI-H/dMMR colorectal cancer.”