After a review of data -- including clinical trial data provided by the manufacturer, the U.S. Food and Drug Administration and the European Medicines Agency -- Health Canada concluded Avastin, or bevacizumab, has not been shown to be safe and effective.
Health Canada officials said the agency directed Hoffmann-La Roche Ltd., the drug's manufacturer, to remove the use for metastatic -- cancer that has spread -- breast cancer from Avastin's label. The company indicated it will comply, Canadian government officials said.
The decision does not affect Health Canada's authorization of Avastin for other types of cancer -- such as metastatic colon, rectal and lung cancers -- or in the treatment of a particular type of brain cancer.
Health Canada's authorization of Avastin for metastatic breast cancer was granted with conditions in February 2009, officials said.
Health Canada concluded Avastin did not significantly reduce tumor size or extend lives, but 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.
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