10 November 2023 - Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE‑966 trial.
Merck today announced the EMA’s CHMP adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma.