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/00083469.PDF. Revised February 2026. Accessed April 2026.

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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. 0
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. 0
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. 0
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. 0
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
OPDIVO (nivolumab), in combination with platinum-doublet chemotherapy, the neoadjuvant treatment of adult patients with resectable Stage II (>4 cm), IIIA, IIIB (T3-4N2) NSCLC and no known epidermal growth factor Opdivo (nivolumab) receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by OPDIVO as a single agent in the adjuvant setting after surgical resection. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations Biomarkers Cancer types Therapies
HC (1) PD-L1 >= 1%, Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Ipilimumab, Nivolumab
HC (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Nivolumab, Paclitaxel
HC (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Nivolumab, Pemetrexed
HC (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Gemcitabine, Nivolumab
HC (1) PD-L1 >= 1% Esophageal Squamous Cell Carcinoma Ipilimumab, Nivolumab
HC (1) PD-L1 >= 1% Esophageal Squamous Cell Carcinoma Cisplatin, Fluorouracil, Nivolumab
HC (1) PD-L1 >= 1% Esophageal Squamous Cell Carcinoma Fluorouracil, Nivolumab, Oxaliplatin
HC (1) BRAF p.V600E Melanoma Nivolumab
HC (1) BRAF p.V600K Melanoma Nivolumab