Regulatory approval

Published by the Food and Drug Administration. Approved

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test.

This is written in the approval document.

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf. Revised February 2026. Accessed March 2, 2026.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) HER2-positive, PD-L1 (CPS) >= 1 Adenocarcinoma of the Gastroesophageal Junction Cisplatin, Fluorouracil, Pembrolizumab, Trastuzumab
FDA (2) HER2-positive, PD-L1 (CPS) >= 1 Adenocarcinoma of the Gastroesophageal Junction Capecitabine, Oxaliplatin, Pembrolizumab, Trastuzumab

Contributions

Date Contributor Description
2025-03-19 Food and Drug Administration Indication received traditional approval.
2024-10-30 Van Allen lab Initial access of FDA approvals
2023-11-16 Food and Drug Administration Indication received accelerated approval.