On 19 March 2025, the US FDA approved MSD’s Keytruda® (pembrolizumab) with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-postiive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 (CPS≥1).
The Keytruda® combination first received accelerated approval for the HER2 positive Gastric/GEJ cancer indication in May 2021 based on an interim analysis of the KEYNOTE-811 trial, with the indication subsequently being revised in November 2023 to add a restriction to patients whose tumours express PD-L1 (Combined Positive Scope [CPS] ≥ 1) as determined by an FDA-approved test.
Keytruda® (with trastuzumab and chemotherapy) was approved in Europe for the same indication in August 2023.