Keytruda (pembrolizumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125514s143lbl.pdf. Revised November 2023. Accessed October 6, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 2
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. 2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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