FDA rescinds approval of Avastin for treating breast cancer

Experts say side effects outweigh benefits

WASHINGTON - The FDA says one of the most promising cancer drugs to come along in years -- should not be used to treat breast cancer anymore.          

Tumors need blood to survive.  Avastin, which is manufactured by Roche, targets blood vessels.  The drug works by effectively starving tumors until they begin to shrink.  It's typically used in combination with other chemotherapy drugs.

Dr. David Riseberg has prescribed Avastin at Mercy Medical Center's Oncology Clinic in Baltimore.  He says despite the promise -- there have been problems.

"It's a drug for which, as data has become more available we have not seen consistently positive results," he said.

And on Friday the FDA announced that it would revoke its earlier approval of Avastin, for use in the treatment of breast cancer.

"The most important thing for people to know about this drug is that although it can kill cancer, unfortunately it's killing patients," said Diana Zuckerman, of the National Research Center for Women and Families.

That's because Avastin has been known to cause severe side effects -- including high blood pressure, bleeding and even heart failure.

Still, many patients feel strongly that it should remain available for late-stage breast cancer treatment.  Dr. Riseberg says the FDA can't act with emotion -- only the facts it has on hand.

"I can understand the frustration of women who feel that an option has been taken away from them," he said.  "But on the flip side, do we want to be exposing all of these women to a drug for whom the benefits aren't clear, but we know that the side effects are clear?"

Still -- he still believes Avastin can be effective in treating breast cancer.  The key, he says, is more research into finding out how to identify which women would benefit from the tumor-killing effects of Avastin, and which would not.\

"I'm not sure that there aren't women for whom Avastin might be beneficial, just we need to learn better how to delineate them," Dr. Riseberg said.\

Without the FDA's approval, some insurance companies are likely to stop covering the cost of Avastin for breast cancer treatment.  if you pay for it out of pocket, it can cost more than $8,000 a month.

The drug was initially approved to treat colon cancer; it remains approved by the FDA for that.

Following is a statement from the Susan G. Komen for the Cure organization, regarding the FDA's decision: