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.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of this submission was to seek market authorization for Opdivo (nivolumab), in combination with ipilimumab, for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) with no Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) genomic tumour aberrations.
After evaluation of the submitted data package, Health Canada authorized Opdivo for the following indication:
Metastatic NSCLC expressing PD-L1 ≥1%, as determined by a validated test, with no EGFR or ALK genomic tumour aberrations and no prior systemic treatment for metastatic NSCLC, when used in combination with ipilimumab.
Why was the decision issued?
Authorization was based on the results from a Phase 3, multi-part, randomized, open-label, controlled trial in patients with metastatic or recurrent NSCLC who had not received prior systemic treatment for metastatic disease.
The primary evaluation of efficacy was based on the comparison of Opdivo in combination with ipilimumab (N = 396) with platinum-doublet chemotherapy (N = 397) in patients with tumour PD-L1 expression ≥1%. Patients received 3 mg/kg Opdivo every 2 weeks plus 1 mg/kg ipilimumab every 6 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity, or platinum-doublet chemotherapy every 3 weeks for a maximum of 4 cycles or until disease progression or unacceptable toxicity.
The results of the primary efficacy endpoint demonstrated a statistically significant improvement in overall survival with Opdivo plus ipilimumab compared to platinum-doublet chemotherapy in patients with PD-L1 tumour expression ≥1%. The median OS was 17.1 months with Opdivo plus ipilimumab and 14.9 months with platinum-doublet chemotherapy.
The most common adverse reactions in patients who received Opdivo plus ipilimumab included fatigue, rash, diarrhea/colitis, hypothyroidism, decreased appetite, pruritis, increased transaminases and nausea. The risks associated with this combination therapy are consistent with the safety profiles of nivolumab and ipilimumab that have previously been observed.
The recommended dose is Opdivo 3 mg/kg every 2 weeks and ipilumumab 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression. View the Opdivo Product Monograph for details.
Overall, based on the improvement in overall survival with Opdivo plus ipilimumab compared to platinum-doublet chemotherapy, the benefit-risk profile is considered favourable for the target patient population.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.