FDA Approval Alert: The Need-to-Know | Pembrolizumab/Chemotherapy in First-Line Gastric/GEJ Adenocarcinoma
In March 2025, the FDA approved pembrolizumab plus trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy in the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma with a PD-L1 combined positive score of 1 or higher.
FDA Approves Pembrolizumab/Chemo in First-Line Gastric/GEJ Adenocarcinoma
Article
By Tim Cortese
Mar 19, 2025 6:05 PM
Data from the phase 3 KEYNOTE-811 trial supported the FDA approval of this pembrolizumab combination in locally advanced unresectable or metastatic, PD-L1–positive, HER2-positive gastric or GEJ adenocarcinoma.
