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FDA: Avastin should not be used to treat breast cancer

MATTHEW PERRONE | 12/21/2010, 6:55 p.m.

WASHINGTON — Federal health authorities recommended last week 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 drug-maker 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.

“Today’s decision was a difficult one for the agency but certainly not unique,” said Dr. Janet Woodcock, director of FDA’s drug center. “The FDA is responsible for assuring that the products we approve for patients are both effective and safe.”

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.

“Given the number of serious and life-threatening side effects, the FDA does not believe there is a favorable risk-to-benefit ratio,” said Dr. Richard Pazdur, FDA’s chief of cancer drug review.

In a separate announcement last Thursday, the European Medicines Agency said it would keep the drug available as a combination treatment with the chemotherapy drug paclitaxel — the same use rejected by the FDA.

FDA officials said the split opinion was due to differences in how Avastin was approved in the U.S. versus Europe. The FDA cleared the drug under its accelerated approval program, giving the agency the option to rescind approval if follow-up studies didn’t confirm initial results. European regulators granted the drug full approval based on the same results, making it more difficult to reverse course when faced with weaker follow-up results.

If the FDA ultimately removes Avastin’s breast cancer indication, doctors will still have the option to prescribe the drug “off-label,” or without a federal approval, but many insurers do not reimburse drugs for such uses. Without insurance coverage, Avastin’s enormous cost would put it out of reach for most patients.

Roche sells the drug at a wholesale price of $7,700 a month. When infusion charges are included, a year’s treatment with Avastin can run more than $100,000, though Roche caps spending at $57,000 per year for patients who meet certain financial criteria.