FDA revokes Avastin breast cancer approval
January 2012

SILVER SPRING, Md.ó 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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