The FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) in combination with trastuzumab and 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.
The approval was based on data from the ongoing phase 3 KEYNOTE-811 trial (ClinicalTrials.gov Identifier: NCT03615326) with planned enrollment of 692 patients with