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 supplemental new drug submission (SNDS) was to seek the authorization of Opdivo (nivolumab) with conditions for use in patients with advanced hepatocellular carcinoma.
Why was the decision issued?
The Sponsor provided a pivotal, multi-national, open label, phase I/II single arm study of Opdivo conducted in patients with advanced hepatocellular carcinoma (HCC) that had received prior sorafenib treatment.
In these HCC patients, Opdivo treatment achieved objective response rates (ORRs) of 15% as assessed by a blinded independent review committee (BICR). This efficacy result is considered promising for the indicated population. However, the clinical trial had no comparative data demonstrating a survival or quality of life benefit in the advanced HCC population after sorafenib treatment. The promising efficacy results are expected to be verified by an on-going phase III randomized study comparing Opdivo to sorafenib as first-line treatment in patients with advanced HCC.
The safety profile of Opdivo was evaluated in 145 patients with locally advanced or metastatic HCC that were intolerant to or progressed on sorafenib. Generally, the identified toxicities were:
- consistent with the known toxicity profile of Opdivo observed in other clinical trials or indications;
- clearly highlighted in the Adverse Reaction and Warnings and Precautions section of the product monograph (PM);
- tolerable; and
- managed using standardized algorithms, across the Opdivo program for medical intervention, dose delay, and/or discontinuation. All of these mitigation strategies are clearly captured in the PM.
In conclusion, given the information provided in the submission and the lack of therapies for patients with this serious life-threatening disease, Opdivo is considered to have a positive benefit/risk profile under the proposed conditions of use. Confirmatory data will be provided to Health Canada as a commitment. The PM has been updated to reflect the new safety and efficacy data from this clinical trial.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.