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NOVEMBER 16, 2023

FDA Approves Keytruda With Chemotherapy for HER2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma

The FDA approved pembrolizumab (Keytruda, Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Efficacy was evaluated in KEYNOTE-859, a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 1,579 patients with HER2-negative advanced gastric or GEJ adenocarcinoma who had not previously received