Merck Reports Positive CHMP Opinion For KEYTRUDA - Quick Facts

(RTTNews) - Merck (MRK) said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA as first-line treatment in adult patients with Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) colorectal cancer. The opinion was granted based on significant progression-free survival benefit demonstrated with KEYTRUDA monotherapy compared to standard-of-care chemotherapy in phase 3 KEYNOTE-177 trial.

The company said the CHMP's recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the first quarter of 2021.