FDA Advises Against Avastin as a Breast Cancer Treatment

Federal authorities have recommended that Avastin — the world’s best-selling cancer drug — no longer be used to treat breast cancer, saying that recent studies failed to show the drug’s original promise that it could help extend patients’ lives, the Associated Press reports.

The recommendation by the U.S. Food and Drug Administration does not affect other approved uses of Avastin, such as in the treatment of lung, kidney, colon and brain cancers. FDA officials stressed that their recommendation is only a preliminary step toward revoking the drug’s approval for breast cancer and, The New York Times reports, it is likely to remain approved for use against breast cancer at least for a few more months.

Swiss drugmaker Roche, whose Genentech unit makes Avastin, is expected to challenge the FDA recommendation, and the company issued a statement that would request a public meeting on the issue.

Though the move has sparked fears among some women who will no longer be able to take a drug they believe is extending their lives, patient advocacy groups applauded the decision, saying that breast cancer patients need more than false hope. According to Genentech, Avastin is used by about half of the 29,000 patients diagnosed with metastatic breast cancer every year.

“I understand that today’s recommendation from the FDA is disappointing for patients with breast cancer,” Dr. Richard Pazdur, head of the agency’s cancer drug division, told reporters in a conference call. “Please note that these findings are also disappointing for the FDA as well.”

The FDA action came the same day that the European Medicines Agency, relying on the same studies, moved to keep the drug available to patients, but in a narrower way than before.

Many experts said Avastin appeared to help some patients live longer but right now, The Times said, it is impossible to predict which patients. If Genentech could figure out how to predict this — such as by a genetic test — the drug possibly could remain approved for some breast cancer patients in the U.S.

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