Keytruda Receives Traditional Approval for Some Patients With HER2-Positive Gastric or GEJ Adenocarcinoma

The FDA has 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 gastroesophageal junction (GEJ) adenocarcinoma whose tumors express programmed death ligand-1 (PD-L1) (combined positive score [CPS] ≥1).

Pembrolizumab previously received accelerated approval for this indication on May 5, 2021, based