Therapeutic Response Statement (Sensitivity)

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

The U.S. Food and Drug Administration (FDA) granted approval to nivolumab as a single agent for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

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

OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Citation

Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s129lbl.pdf. Revised April 2025. Accessed April 30, 2025. Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s063lbl.pdf. Revised July 2018. Accessed October 6, 2026.

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Contributions

Date Contributor Description
2025-04-30 Van Allen lab The FDA provided regular approval to nivolumab in combination with ipilimumab the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. However, they split the approval in two indications: as a single agent and still as a combination for patients who have progressed on the previously listed therapies. We added a new indication to cover the combination treatment and updated all statements and propositions accordingly.
2024-10-30 Van Allen lab Initial access of FDA approvals
2024-04-08 Food and Drug Administration Indication received traditional approval.
2018-07-10 Food and Drug Administration Indication received accelerated approval.