Regulatory approval
Published by the European Medicines Agency.
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 is written in the approval document as:
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.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | MSI-H | Colorectal Adenocarcinoma | Pembrolizumab | |
| Sensitivity (+) | dMMR | Colorectal Adenocarcinoma | Pembrolizumab |