Avastin shouldn’t be used for breast cancer, FDA says

Federal health authorities recommended Thursday that the blockbuster drug Avastin no longer be used to treat breast cancer, saying recent studies failed to show the drug’s original promise to help slow the disease and extend patients’ lives.

The rare decision by the Food and Drug Administration is supported by many cancer experts but drew fierce opposition from cancer patients and some doctors who defend the drug and say it should remain available.

The ruling is a significant setback for the world’s best-selling cancer drug and will likely cost Swiss drugmaker Roche hundreds of millions of dollars in lost revenue. Avastin is also approved for various types of colon, lung, kidney and brain cancer.

FDA officials stressed that the recommendation is only a preliminary step toward revoking the drug’s approval for breast cancer. Roche has refused to voluntarily withdraw the indication, and the company said in a statement it would request a public meeting on the issue.

Drug companies almost always follow FDA requests, and agency officials said a meeting over the fate of Avastin would be the first of its kind. The agency said it will consider whether to hold the meeting in the coming months.

The FDA approved Avastin for breast cancer in 2008 based on one study suggesting it halted the spread of breast cancer for more than five months when combined with chemotherapy. But follow-up studies showed that the delay lasted no more than three months, and patients suffered dangerous side effects.