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Breast Cancer: FDA Considers Avastin Withdrawal

Photo Courtesy - Getty Images(WASHINGTON) -- New evidence suggests the benefits do not outweigh the risks of Avastin for treating metastatic breast cancer, according to officials at the U.S. Food and Drug Administration. The agency has now begun the process of withdrawal of the popular advanced breast cancer treatment.

The FDA granted an accelerated conditional approval for Avastin in February 2009 to treat late-stage breast cancer patients. The drug, it had been suggested, slowed the progression of the disease or improved overall survival.

But results from four new trials that enrolled more than 3,000 women found no significant reduction in disease progression or death among those who took Avastin along with chemotherapy.

"These trials were intended to confirm progression-free survival, and they did not," Dr. Janet Woodcock, director of the FDA's Center of Drug Evaluation and Research, said at a news conference. "There was no symptomatic benefit and no effect in overall survival."

Avastin is still available to patients, but the announcement is the beginning of a regulatory withdrawal of the drug from the market. And some cancer specialists say the basis of the announcement has huge implications for the way their patients will be treated.

Still, the studies not only showed no overall benefit from the drug, but even suggested some patients had an increased risk of death because Avastin is, in some ways, toxic.

"We would encourage at this time patients to discuss with their physician what the appropriate action should be," said Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products.

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