Regulatory Decision Summary for Avastin
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) is to support the extension of the use of AVASTIN in combination with carboplatin and gemcitabine for the treatment of patients with first recurrence of platinum-sensitive epithelial ovarian cancer (EOC), fallopian tube cancer (FTC) and primary peritoneal cancer (PPC). These patients should not have received prior vascular endothelial growth factor (VEGF)-targeted therapy including AVASTIN.
Why was the decision issued?
The pivotal trial submitted in support of this proposed indication demonstrated a statistically significant and clinically relevant improvement in progression-free survival (PFS) of AVASTIN in combination with carboplatin and gemcitabine over carboplatin and gemcitabine alone (absolute gain of 4 months in median PFS). These results were supported by an improvement in objective response rate (ORR) in the AVASTIN arm. Overall survival benefit was not demonstrated in this study.
As expected, patients treated with AVASTIN in combination with gemcitabine and carboplatin resulted in increased safety findings compared to patients who only received gemcitabine and carboplatin. However, the overall safety profile of AVASTIN appears to be consistent with the known safety profile of AVASTIN and is consistent with the experience of AVASTIN across indications. All safety concerns were adequately captured in the Product Monograph (PM).
In view of the clinically meaningful PFS benefit associated with an ORR improvement in the context of this recurrent disease and a manageable safety profile, the overall risk benefit profile of AVASTIN appears to be favourable for the treatment of patients with first recurrence of platinum-sensitive ovarian cancer.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.