On March 19, the Food and Drug Administration granted traditional approval to pembrolizumab, or Keytruda, marketed by Merck (MRK), 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 adenocarcinoma whose tumors express PD-L1. Pembrolizumab previously received accelerated approval for this indication on May 5, 2021, based on interim analysis of a previous trial.
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