More Hearings On Avastin Later This Month

Controversy over the Food and Drug Administration's (FDA) proposal to withdraw approval of Avastin for breast cancer treatment will likely heat up again at the end of the month.

The FDA will hold a new round of hearings on the subject June 28-29, with the drug's manufacturer, Genentech, arguing for its continued approval.

Arguing against that will be oncologist Dr. Frederick C. Tucker Jr., of Fredericksburg, Va. His recent oped piece in the New York Times defended the FDA's position on scientific grounds. In the piece, Tucker contends that Genentech has been unable to show that patients taking the medication live longer or with an improved quality of life.

“It was this lack of demonstrated clinical benefit, combined with the potentially severe side effects of the drug, that led the FDA last year to reject the use of Avastin with Taxol or with the other chemotherapies for breast cancer,” Tucker wrote.

Anecdotal

Tucker maintains the evidence presented to support the drug is anecdotal.

“But anecdote is not science,” Tucker said. “Such testimonials may represent the human voices behind the statistics, but the sad fact is that there are too many patients who have been treated with Avastin but are not here to tell their stories.”

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.

Risks

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.

Avastin was approved for the treatment of breast cancer in 2008, in spite of an FDA advisory panel's recommendation against approval. If FDA upholds its decision to withdraw approval for breast cancer treatment, Avastin can still be used to treat the disease, Genenetech will just be unable to market it for that purpose.