Panel: Avastin Not A Treatment For Breast Cancer

A Food and Drug Administration (FDA) panel, hearing an appeal of its preliminary decision against the use of Avastin as a breast cancer treatment, was not persuaded to change its position.

The panel ruled Wednesday that the FDA should end the use of Avastin as a recommended treatment for breast cancer. FDA Commissioner Margaret Hamburg will make the final decision, but the agency normally follow its panels' advice.

The ruling came in spite of strong pleas from breast cancer patients and Genentech, the pharmaceutical company that makes the drug. However, panel members said that clinical trials simply failed to bear out the early promise for the drug.

Other uses okay

If the FDA removes approval of Avastin as a breast cancer treatment, the drug will remain on the market and can be prescribed for other cancers. However, Genentech will no longer be allowed to market it as a breast cancer treatment.

More importantly, insurance companies will no longer pay for it to treat breast cancer. The drug costs about $88,000 a year to treat one patient.

Last December FDA recommended removal of the breast cancer indication from the label for Avastin because it said the drug has not been shown to be safe and effective for that use.

The recommendation followed a review of the results of four clinical studies of Avastin in women with breast cancer and a determination 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.