Health Canada

Health Canada

November 28, 2011 16:20 ET

Health Canada Directs Hoffmann-La Roche to Remove Use of Avastin (Bevacizumab) for the Treatment of Metastatic Breast Cancer from the Product Label

OTTAWA, ONTARIO--(Marketwire - Nov. 28, 2011) - Health Canada is advising Canadians of its decision to suspend authorization of Avastin for use in the treatment of a certain type of breast cancer (metastatic breast cancer).
Based on careful review, Health Canada has concluded that Avastin (the brand name for the drug bevacizumab) has not been shown to be safe and effective in this use. Hoffmann-La Roche Ltd., the manufacturer of Avastin, has been directed to remove the use for metastatic breast cancer from Avastin's label. The company has indicated it will comply.

This decision does not affect Health Canada's authorization of Avastin for other types of cancer. Avastin remains authorized in Canada for use in the treatment of metastatic colon, rectal, and lung cancers, as well as in the treatment of a particular type of brain cancer (glioblastoma). Metastatic cancer is cancer that has spread ("metastasized") to other parts of the body.

Suspending an authorization for a drug on the market is not a decision taken lightly. It must be based on a thorough review of the scientific evidence and careful evaluation of the potential benefits and risks of the product to patients.

Health Canada's authorization of Avastin for metastatic breast cancer was granted with conditions in February 2009. Health Canada will grant authorization for a drug (or a particular use of that drug) under its Notice of Compliance with Conditions Policy (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/fs-fi/noccfs_accfd-eng.php) if the drug shows promising evidence of clinical effectiveness, subject to follow-up studies that confirm the benefit.

Health Canada has concluded that Avastin does not significantly reduce tumour size or extend lives, while it may cause serious and potentially life-threatening risks, such as heart attacks, severe high blood pressure, bleeding, and the development of small tears in parts of the body such as the nose, stomach or intestines. Several alternatives remain available in Canada for the treatment of metastatic breast cancer that deliver equivalent or better benefits than Avastin, with fewer risks.

Health Canada's decision is based on a thorough review of scientific data in the context of Canadian medical practice, including clinical trial data provided by the manufacturer, and information from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Health Canada also considered advice provided by an independent Expert Advisory Panel convened in March 2011 at Health Canada's request.

The Panel, which included oncologists, scientists and breast cancer patient advocates, unanimously concluded that the potential harm of using Avastin is of such magnitude that the risks of the drug far outweigh potential benefits, and that, based on the current available evidence, there is no value in maintaining Avastin as a treatment option. The Report of the Expert Advisory Panel (http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/sci-consult/avastin/report-rapport-eng.php) is available on the Health Canada website.

Health Canada will communicate additional information to health professionals and Canadians as necessary. Patients with questions or concerns regarding their Avastin treatment should speak to their healthcare professional.

How to report side effects to health products

To report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) and send to us using one of these methods:

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Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9

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