Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that MSI-H status confers therapeutic sensitivity to Pembrolizumab in patients with Colorectal Adenocarcinoma.

The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy for the treatment of adult patients with microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR) colorectal cancer as a first line-treatment for metastatic colorectal cancer or treatment of unresectable or metastatic colorectal cancer after previously fluoropryimidine-based combination therapy.

This statement is based on a regulatory approval from the European Medicines Agency:

KEYTRUDA as monotherapy is indicated for adults with MSI-H or dMMR colorectal cancer in the following settings: first-line treatment of metastatic colorectal cancer; treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine -based combination therapy.

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.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2021-01-21	European Medicines Agency	Indication received approval from the European Commission.