FDA revokes approval of Avastin for breast cancer

Drug regulators withdrew their approval of Roche's Avastin for breast cancer, saying the drug was not effective enough to justify its risks even if patients believe it has helped them live longer.

Reversing course on a drug that was approved for the disease in 2008, U.S. Food and Drug Administration Commissioner Margaret Hamburg said subsequent research did not confirm hopes that Avastin would help patients with advanced breast cancer live longer or improve quality of life.

The drug will remain on the market for other uses, such as treating types of colon, lung, kidney and brain cancer.

"This was a difficult decision," Hamburg said. "With so much at stake, patients and their doctors count on the FDA to ensure the drugs they use have been shown to be safe and effective for their intended use. Sometimes, the results of rigorous testing can be disappointing."

While doctors still have discretion in using Avastin for breast cancer off-label, the FDA move may lead health insurers to drop coverage of a medicine that costs $88,000 a year.

An estimated 17,000 women are being treated with the drug, and patient advocates insist there are enough examples of survival to justify its use.

"The bottom line is that they are throwing out the baby with the bathwater," said Dr. Elisa Port, co-director of the Dubin Breast Center of Mount Sinai Hospital in New York. "There absolutely may be subsets of carefully chosen breast cancer patients who benefit from Avastin."

Roche said it will pursue a new Phase III study of Avastin in combination with the chemotherapy drug paclitaxel to look for biological clues about which breast cancer patients may benefit from the drug, clinically known as bevacizumab.

The Swiss drugmaker still expects Avastin, its top medicine, to generate peak annual sales of 7 billion Swiss francs ($7.6 billion), despite the FDA's decision. Analysts have said a withdrawn FDA approval for breast cancer could cost nearly $1 billion in sales.

Roche stock ended 0.5 percent lower at 142.60 Swiss francs in Switzerland on Friday. Its decline was in line with a 0.7 percent fall in the European healthcare index.

MEDICARE STILL PLANS TO COVER

The FDA determined in December 2010 that it should revoke its approval of Avastin for breast cancer, but an appeal from Roche and the outcry from patients led it to convene a hearing of advisers in June.

Some insurers have already started pulling back on Avastin coverage for breast cancer. But the U.S. government's Medicare insurance program will continue covering Avastin for the use, said a spokesman for the Centers for Medicare and Medicaid.

"CMS will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies," spokesman Don McLeod said.