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 the submission was to review the data for Opdivo (nivolumab) in the treatment of unresectable or metastatic melanoma. The indication authorized under this Notice of Compliance with conditions (NOC/c) is "Opdivo, 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."
Why was the decision issued?
The Phase III Study CA209037 demonstrated an objective response rate of 31.7% (95% confidence interval: 23.5, 40.8) in the nivolumab treated subjects who received at least one dose of treatment and had at least 6 months of follow-up at the time of analysis. This select cohort, consisting of 120 patients out of 272 (44%) randomized patients in the nivolumab group, demonstrated promising clinical benefit as a second or third line (if BRAF V600 mutation) treatment for unresectable or metastatic melanoma which is a life threatening disease. As part of the NOC/c commitment, the sponsor has agreed to provide the results of a multicenter, randomized trial establishing the superiority of nivolumab over standard therapy in adult patients with unresectable or metastatic melanoma who are refractory to ipilimumab or who have not been previously treated with ipilimumab. The final report of the completed trial CA209037 entitled "A Randomized, Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigators Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy" with overall survival results will be submitted to fulfill this commitment.
Decision issued
Approved; issued Notice of Compliance with Conditions in accordance with the Food and Drug Regulations.