5 May 2021 - Today the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastro-oesophageal junction adenocarcinoma.

Approval was based on the pre-specified interim analysis of the first 264 patients of the ongoing KEYNOTE-811 trial, a multicenter, randomised, double‑blind, placebo‑controlled trial in patients with HER2‑positive advanced gastric or gastro-oesophageal junction adenocarcinoma who had not previously received systemic therapy for metastatic disease.

Read FDA press release