On Nov. 7, 2023, the FDA revised the existing indication of pembrolizumab (Keytruda, Merck) with trastuzumab-, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express programmed death ligand-1
NOVEMBER 10, 2023