11 December 2020 - Opinion granted based on significant progression-free survival benefit demonstrated with Keytruda monotherapy compared to standard of care chemotherapy in pivotal Phase 3 KEYNOTE-177 trial.
Merck announced today that the CHMP of the EMA has adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.