19 March 2025 - Today, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma whose tumours express PD-L1.

Pembrolizumab previously received accelerated approval for this indication on 5 May 2021, based on interim analysis of the KETNOTE-811 trial.

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