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.
Product type:
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Type of submission:
Control number:
What was the purpose of this submission?
This SNDS (control # 171255) was submitted to support the extension of the use of Avastin in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin for the treatment of patients with recurrent, platinum-resistantepithelial ovarian (EOC), fallopian tube (FTC), or primary peritoneal cancer (PPC) who received no more than two prior chemotherapy regimens.
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 paclitaxel, topotecan or pegylated liposomal doxorubicin over paclitaxel, topotecan or pegylated liposomal doxorubicin alone (absolute gain of 3.4 months in median PFS). These results were supported by an improvement in objective response rate (ORR) (partial responses) in the AVASTIN with chemotherapy treatment arm. The overall survival benefit was numerically in favour of the AVASTIN with chemotherapy treatment arm but the results were not statistically significant.
As expected, patients treated with AVASTIN resulted in increased safety findings compared to patients who received chemotherapy alone. However, the overall safety profile of AVASTIN in this population of patients 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 serious but identified safety profile, the overall risk benefit profile of AVASTIN appears to be favourable for the treatment of recurrent platinum-resistant ovarian cancer in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin in patients that have received no more than two prior chemotherapy regimens.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.