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FDA Mulls Fate of Avastin as Breast Cancer Drug

Patients and Doctors Testify About Safety and Effectiveness of Avastin for Advanced Breast Cancer
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Controversy Over Avastin continued...

This slight difference in progression-free survival "comes at a toxicity cost," says Lee H. Pai-Sherf, MD, a medical officer in the FDA's Division of Biologic Oncology Products.

Those studies have also shown that breast cancer patients taking Avastin have higher rates of adverse events compared to standard chemotherapy drugs. One study found that half of women taking Avastin experienced episodes of bleeding, a rate that was twice as high as women on a standard chemotherapy drug.

Other serious side effects experienced by women on the drug include high blood pressure, heart attacks, heart failure, protein in the urine (a sign of kidney damage), and gastrointestinal perforations -- holes in the lining of the stomach or intestines.

Accelerated Approval Program

In December 2010, the FDA announced that it would withdraw its conditional approval as a treatment for breast cancer.

Genentech, the company that makes Avastin, is appealing that decision and has taken the rare step of requesting a public hearing. The company will present its case tomorrow.

Today, regulators took pains to lay out the evidence they used to conclude that Avastin should no longer be prescribed for breast cancer.

"The totality of the data show that the Avastin has only a modest effect on PFS [progression-free survival], and this small effect, in the absence of an effect on overall survival or patient quality of life, does not outweigh its substantial and life-threatening risks," says John K. Jenkins, MD, director of the office of new drugs at the FDA's center for drug evaluation and research.

Jenkins called withdrawal "the right public health decision."

If the FDA sticks by its withdrawal of Avastin's approval for breast cancer, the drug, which can cost as much as $100,000 a year, will remain on the market, but insurance companies are less likely to cover it for that use.

Breast cancer patients would also lose access to the drug through the company's patient assistance program, which caps the drug's annual cost at about $58,000.

Since 1995, Jenkins says, the FDA has granted 49 indications for cancer drugs through its "accelerated approval" process.

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