FDA revokes Avastin’s OK as drug to treat breast cancer

After fast-track approval, fatal strokes, heart attacks shown to be side effects



LOS ANGELES — The cancer drug Avastin should not be used to treat breast cancer that has spread to other organs because it doesn’t help patients enough to justify its risky side effects, the Food and Drug Administration ruled Friday.

The decision comes five months after an FDA advisory committee recommended that the federal agency withdraw its approval of Avastin for breast cancer patients. FDA Commissioner Margaret A. Hamburg said the choice was difficult because so many women and their doctors have put their faith in the drug and lobbied hard on its behalf.

“Sometimes,” she said, “despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing.”

Avastin will remain on the market for treating types of cancer where the benefits clearly outweigh the risks, such as lung, kidney and colon cancer, Hamburg said. Doctors will have the flexibility to prescribe it for breast cancer patients as an off-label use, but insurance companies might not pay for it.

The drug, among the top-selling cancer therapies, is a biological antibody designed to interfere with the blood supply that feeds a tumor and helps it grow and spread. But it can cause harsh side effects, including heart attacks and strokes. It’s also among the most expensive cancer therapies, costing upward of $50,000 a year.

The FDA approved Avastin for metastatic breast cancer in 2008 after a study in the New England Journal of Medicine showed that patients who took it in conjunction with a chemotherapy drug experienced six additional months of progression-free survival compared with patients who only took the chemo drug. It was the first medicine OK’d under an accelerated approval program that allowed use while researchers gathered additional data to clarify its safety and efficacy.

The approval was controversial, since an FDA advisory panel had voted 5-4 against the drug just a few months earlier.

Two subsequent studies showed that Avastin seemed to slow tumor growth significantly in breast cancer patients but did not extend survival.

That soured experts charged with monitoring new data on the drug’s pros and cons. The FDA moved to withdraw Avastin’s approval for breast cancer patients in December 2010, but the drug’s manufacturer, Genentech Inc., challenged the agency.

Medications that are fast-tracked require a rigorous continued review, Hamburg said. “We do believe withdrawal is an essential component of the accelerated approval program,” she said.

Avastin’s ability to help patients with advanced breast cancer live longer has always been in doubt, and few experts expressed surprise at the FDA action.

“It does not improve survival,” said Dr. Joanne Mortimer, director of the Women’s Cancers Program at City of Hope in Duarte, Calif., who served on two of the three FDA advisory panels that debated Avastin’s use for breast cancer. “Yes, it keeps your cancer under control longer. But … the risks are pretty huge.”

Studies showed that women with advanced breast cancer taking Avastin had a higher risk of deaths from strokes and heart attacks.