Posted by Michael Wonder on 13 Apr 2023
FDA accepts application for Merck’s Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for locally advanced unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma
13 April 2023 - Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression.
Merck today announced the US FDA has accepted for review a new supplemental biologics license application seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma.
