Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized pembrolizumab in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-esophageal junction adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) >= 1.

This is written in the approval document as:

KEYTRUDA, in combination with fluoropyrimidine and platinum -containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro -oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS >= 1.

Citation

Merck Sharp & Dohme B.V. Keytruda (pembrolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf. Revised January 2024. Accessed March 10, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	HER2-negative, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Pembrolizumab
EMA (1)	HER2-negative, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Carboplatin, Fluorouracil, Pembrolizumab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2023-11-23	European Medicines Agency	Indication received approval from the European Commission.