FDA Removes Breast Cancer Treatment Approval From Avastin

In what was probably a foregone conclusion, the U.S. Food and Drug Administration (FDA) has ruled the the cancer drug Avastin should not be used to treat breast cancer because there is no evidence that it is effective.

The drug remains on the market, since it is used primarily to treat colon cancer. It is still approved for that use.

Many breast cancer parients will likely be disappointed with the ruling, but FDA Commissioner Margaret Hamburg said the decision, though difficult, was necessary because patients have to have confidence the medication they are taking is effective.

Move not unexpected

As expected, the FDA took the advice of its panel of experts that studied the drug and its use to treat breast cancer. In June the panel recommended that Avastin not be used for breast cancer.

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 at the time that clinical trials simply failed to bear out the early promise for the drug.

Though Avastin will remain on the market, 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.