Opdivo (nivolumab) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
OPDIVO (nivolumab) is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor.	2
OPDIVO, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on a therapy for these aberrations prior to receiving OPDIVO.
OPDIVO (nivolumab) in combination with ipilimumab, is indicated for the treatment of adult patients with metastatic NSCLC, expressing PD-L1 ≥ 1% as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and no prior systemic therapy for metastatic NSCLC.	1
OPDIVO (nivolumab), in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no EGFR or ALK genomic tumour aberrations, and no prior systemic therapy for metastatic NSCLC.
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.
OPDIVO (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with HER2 negative advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma.
OPDIVO (nivolumab), in combination with ipilimumab, 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.	1
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRAF p.V600E	Melanoma	Nivolumab
Sensitivity (+)	BRAF p.V600K	Melanoma	Nivolumab
Sensitivity (+)	PD-L1 >= 1%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Ipilimumab, Nivolumab
Sensitivity (+)	PD-L1 >= 1%	Esophageal Squamous Cell Carcinoma	Ipilimumab, Nivolumab
Sensitivity (+)	PD-L1 >= 1%	Esophageal Squamous Cell Carcinoma	Cisplatin, Fluorouracil, Nivolumab
Sensitivity (+)	PD-L1 >= 1%	Esophageal Squamous Cell Carcinoma	Fluorouracil, Nivolumab, Oxaliplatin