Regulatory approval

Published by the Health Canada.

Health Canada approved nivolumab, in combination with ipilimumab, for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal caner after prior fluoropyrimidine-based therapy in combination with oxaliplatin or irinotecan.

This is written in the approval document as:

OPDIVO (nivolumab), in combination with ipilimumab, is indicated for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer after prior fluoropyrimidine-based therapy in combination with oxaliplatin or irinotecan.

Citation

Bristol-Myers Squibb Canada. Opdivo (nivolumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00076152.PDF. Revised June 2024. Accessed June 2025.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)