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# FDA Updates Keytruda Gastric Cancer Indication
- URL: https://www.fdaweb.com/fda-updates-keytruda-gastric-cancer-indication/
- Published: 2023-11-09T12:00:00.000Z
- Updated: 2026-09-14T14:15:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155758

FDA revised 11/7 the existing indication of Merck’s Keytruda (pembrolizumab) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinomas. An agency [post](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-amends-pembrolizumabs-gastric-cancer-indication?ref=fdaweb.com) says the updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 as determined by an FDA-approved test.

The agency also approved the Agilent PD-L1 IHC 22C3 pharmDx as a companion diagnostic device to select patients with adenocarcinomas whose tumors express PD-L1.