Regulatory Decision Summary for Opdivo
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this submission was to seek market authorization in Canada for Opdivo for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations, in combination with ipilimumab and platinum-doublet chemotherapy. After evaluation of the submitted data package, Health Canada authorized Opdivo for the following indication:
Opdivo, 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 tumor aberrations, and no prior systemic therapy for metastatic NSCLC.
Why was the decision issued?
The safety and efficacy of in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy was assessed in a Phase 3, randomized, open-label study in 719 adult patients with metastatic NSCLC, and no EGFR or ALK genomic tumor aberrations. The study results demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) for Opdivo + ipilimumab + 2 cycles of platinum-doublet chemotherapy compared to 4 cycles of platinum-doublet chemotherapy. Median OS improved by 3.4 months. This survival benefit is supported by improved progression-free survival, a higher objective response rate, and longer duration of response in patients treated with Opdivo in combination with ipilimumab and platinum-doublet chemotherapy.
The most frequently reported adverse reactions in patients treated with Opdivo 360 mg in combination with ipilimumab 1 mg/kg and 2 cycles of platinum-doublet chemotherapy were fatigue, nausea, rash, anemia, diarrhea, pruritus, decreased appetite, hypothyroidism, neutropenia, and vomiting. The safety profile of Opdivo + ipilimumab + platinum-doublet chemotherapy is consistent with the known safety profiles of Opdivo, ipilimumab and platinum-doublet chemotherapy, and reflects the use of these three therapies in combination. Generally, adverse reactions were manageable using existing algorithms and no new safety concerns were identified for Opdivo. The Canadian Product Monograph has been updated for the safety profile of the proposed combination use.
Overall, the benefits of treatment with Opdivo in combination with ipilimumab and platinum-doublet chemotherapy outweigh the risks in the indicated population with metastatic cancer and an otherwise low survival probability. The benefit/risk profile for Opdivo is considered favourable in the target patient population.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.