Breast Cancer Drug Avastin Revoked

FDA is revoking the approval of the breast cancer indication for Avastin after concluding that the drug has not been shown to be safe and effective for that use.

FDA Commissioner Margaret A. Hamburg, M.D., said she is revoking the agency's approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.

Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).

Avastin's risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.

The decision, outlined in Dr Hamburg's 69-page opinion, involv