FDA revokes Avastin breast cancer approval
January 2012
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SILVER SPRING, Md.— Margaret Hamburg, U.S. Food and Drug Administration (FDA) commissioner, announced last month that Roche's Avastin for the treatment of HER2-negative metastatic breast cancer is losing its FDA approval as a result of not being shown to be safe and effective for use. The decision follows a June vote by an FDA panel that Avastin should no longer be approved as a breast cancer treatment. Avastin's side effects have included bleeding and hemorrhaging, heart attack or heart failure, severe hypertension and the development of perforations in different parts of the body. A spokeswoman for Roche's Genentech unit said the company was "disappointed," but will continue pursuing a Phase III study for the drug in untreated metastatic breast cancer in hopes of regaining approval. Analysts are predicting the loss of approval could send Avastin sales plummeting by about $1 billion.

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