Therapeutic Response Statement (Sensitivity)

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

The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC), as determined by an FDA-approved test.

This statement is based on a regulatory approval from the Food and Drug Administration:

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf. Revised February 2026. Accessed March 2, 2026. Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s084lbl.pdf. Revised June 2020. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals