Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy as a first-line treatment for adult patients with locally advanced unresectable or metastatic esophageal carcinoma whose tumors express PD-L1 with a combined positive score (CPS) >= 10. This indication is based on KEYNOTE-590, randomised, double-blind, placebo-controlled trial of 749 patients in which cisplatin and fluorouracil was evaluated with and without pembrolizumab.

This is written in the approval document as:

KEYTRUDA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD-L1 with a CPS >= 10.

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)	PD-L1 (CPS) >= 10	Esophageal Adenocarcinoma	Cisplatin, Fluorouracil, Pembrolizumab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2021-06-24	European Medicines Agency	Indication received approval from the European Commission.