Regulatory approval

Published by the Health Canada. Approved

OPDIVO (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with unresectable or metastatic ESCC, with tumour cell PD-L1 expression >= 1% as determined by a validated test, and no prior systemic therapy for metastatic ESCC.

This is written in the approval document.

Citation

Bristol-Myers Squibb Canada. Opdivo (nivolumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083469.PDF. Revised February 2026. Accessed April 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	PD-L1 >= 1%	Esophageal Squamous Cell Carcinoma	Cisplatin, Fluorouracil, Nivolumab
HC (1)	PD-L1 >= 1%	Esophageal Squamous Cell Carcinoma	Fluorouracil, Nivolumab, Oxaliplatin

Contributions

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