Regulatory approval

Published by the European Medicines Agency.

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 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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 (CPS) >= 10	Esophageal Adenocarcinoma	Cisplatin, Fluorouracil, Pembrolizumab
Sensitivity (+)	PD-L1 (CPS) >= 10	Esophageal Adenocarcinoma	Carboplatin, Fluorouracil, Pembrolizumab