Regulatory Decision Summary for Stivarga
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?
This submission proposed minor modifications of the indication for Stivarga for metastatic colorectal cancer (mCRC) to change the "KRAS wild type" specification to "RAS wild type" in patients previously treated with an antiEpidermal Growth Factor Receptor (EGFR) therapy.
Why was the decision issued?
Regorafenib was previously approved for use in patients with metastatic colorectal cancer (mCRC) and metastatic gastrointestinal stromal tumors (mGIST). The submitted change was to alter the indication for mCRC to generalize its use to either patients with NRAS or KRAS wild type mutations who have been previously treated with EGFR inhibitors. The review was based on published literature and clinical practice guidance documents. The product monograph was updated to reflect the changes made to the indication.
The submission also included two phase I pharmacokinetic (PK) studies, Study 16653 and Study 16674, as well as a PK modelling were also reviewed and relevant information was added to the product monograph.
The benefit-risk profile of Stivarga (regorafenib) remains unchanged.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.