13 October 2023 - Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE-859 trial.
Merck today announced that the EMA’s CHMP adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 (combined positive score ≥1).