Regulatory approval

Published by the European Medicines Agency. Approved

KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.

This is written in the approval document.

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)	MSI-H	Esophagogastric Adenocarcinoma	Pembrolizumab
EMA (1)	dMMR	Esophagogastric Adenocarcinoma	Pembrolizumab
EMA (1)	MSI-H	Gastrointestinal Stromal Tumor	Pembrolizumab
EMA (1)	dMMR	Gastrointestinal Stromal Tumor	Pembrolizumab
EMA (1)	MSI-H	Cholangiocarcinoma	Pembrolizumab
EMA (1)	dMMR	Cholangiocarcinoma	Pembrolizumab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2022-04-25	European Medicines Agency	Indication received approval from the European Commission.