FDA Begins Process to Remove Breast Cancer Indication From Avastin Label

From FDA Press Release. 2010 Dec 16

The U.S. Food and Drug Administration announced today that the agency is recommending 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.

The agency is making this recommendation 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.

Go to: OncologySTAT:  Trouble for Avastin to read the entire article.

National Public Radio did an hour show about this when the news got out that the FDA was considering dropping Avastin as an approved breast cancer drug. 

Sounded to me like most oncologists were disappointed.  Controversial or not, the guests on the broadcast made it clear Avastin had helped a number of their patients.  Of course they can continue to use the drug off-label.  The problem is insurance carriers may not pay for it now when it is used for breast cancer.

Feel good and keep smiling!  Pat

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