29 August 2023 - Approval based on progression-free survival benefit demonstrated in Phase 3 KEYNOTE-811 trial.
Merck today announced that the European Commission has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 (Combined Positive Score [CPS] ≥1).