The U.S. Food and Drug Administration has recommended to removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.
This recommendation has come after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.
In July 2010, after reviewing all available data an independent advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.
The drug is also approved for the treatment of colon, kidney, brain, and lung cancers. The recommendation that came today does not affect the use of Avastin for other indications.
Genentech, the manufacturer of Avastin has not agreed to remove the breast cancer indication voluntarily, so the FDA has issued a Notice of Opportunity for a Hearing, which permits Genentech to request a public hearing if it wishes to contest the agency’s determination.
Additional studies of Avastin in patients with metastatic breast cancer could be conducted by Genentech to identify a population of patients in which the drug’s benefits exceed the risks
