Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that MSI-H 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.