Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	MSI-H	Colorectal Adenocarcinoma	Nivolumab
FDA (2)	dMMR	Colorectal Adenocarcinoma	Nivolumab

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.