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 Supplement to a New Drug Submission – Confirmatory (SNDS-C) for Opdivo (nivolumab), submitted by Bristol-Myers-Squibb Canada was to remove the following indication: Opdivo as monotherapy for the treatment of adult patients with advanced (not amenable to curative therapy or local therapeutic measures) or metastatic hepatocellular carcinoma (HCC) who are intolerant or have progressed on sorafenib therapy.
Why was the decision issued?
The original indication was granted in March 2018 under the Notice of Compliance with Conditions (NOC/c) pathway based on the tumor objective response rate and duration of response observed in Opdivo treated patients with advanced or metastatic HCC in study CA209040 (CheckMate 040).
The condition of this authorization as agreed upon and stated in the Letter of Undertaking was the submission of final report for the confirmatory study, CA209459 (CheckMate 459) demonstrating an improvement in overall survival (OS) for advanced HCC patients treated with Opdivo over sorafenib.
The results of CheckMate 459 showed no difference between Opdivo and sorafenib with respect to OS or progression-free survival (PFS), a key secondary efficacy endpoint.
Since the initial NOC/c for Opdivo was issued, the treatment landscape for patients with advanced HCC has expanded to include the combination of atezolizumab plus bevacizumab, lenvatinib, regorafenib and cabozantinib – all supported by improvement in OS. The unmet medical need that led to Opdivo receiving NOC/c is no longer present.
The indication for Opdivo’s use in patients with advanced or metastatic HCC is, therefore, to be removed.
For further details about Opdivo, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.