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FDA Advises Against Avastin as Treatment for Breast Cancer
Date:12/16/2010

are likely to respond to this," Spector said. "I don't think this will be the end from the standpoint of investigation and people trying to understand who that subpopulation is. It's just unfortunate that this will put a huge crimp in trying to figure that out."

Another expert, Dr. Julie Gralow, director of breast medical oncology at the Seattle Cancer Care Alliance (SCCA), called the FDA decision "disappointing."

"It is clear that some breast cancer patients derive substantial benefit from Avastin," Gralow, who is also professor in the Medical Oncology Division of the University of Washington School of Medicine, said in a SCAA press statement. "We don't know how to select those tumors or patients yet. It is looking like patient factors, not tumor factors, might be the best way to select those who benefit. To withhold this drug from all patients because some don't benefit is incorrect."

Doctors can continue to prescribe Avastin to patients "off-label," as they do other drugs. But it's unlikely that insurance companies will cover off-label use of the drug given its high price tag, Spector said. Avastin now costs more than $8,000 a month, according to published reports.

The FDA did not rule out the possibility that if Avastin is actually revoked, approval could be restored for certain subgroups of patients who may benefit.

"FDA is ready to work with Genentech on any proposals to conduct additional studies in metastatic breast cancer designed to identify responsive tumors," added Woodcock.

In making the announcement, the FDA predictably followed the recommendation of an advisory panel, which voted 12 to 1 last July to strike breast cancer from the approved uses listed on the Avastin label.

Avastin was okayed in 2008 for use in conjunction with chemotherapy under the FDA's accelerated approval program. Approval was based on one clinical trial in patients with metastatic HER2-negative breast cancer that found a benefit in t
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