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FDA to Hear Appeal on Breast Cancer Drug
Date:6/28/2011

ot have an immediate impact on use of Avastin or the drug's availability."

"Oncologists currently treating patients with Avastin should use medical judgment in deciding whether to continue treatment or explore other treatment options," she added.

Some doctors expressed concern at the FDA's decision last December.

"This is a tough issue. There are women who have clearly responded to the treatment, [and] this is going to be a very difficult pill to swallow for those women," said Dr. Neil Spector, professor of medicine at the Duke Cancer Institute.

"There's a very real possibility that there may be a subgroup of women that 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 would cover off-label use of the drug given its high price tag, Spector said. Avastin costs more than $8,000 a month, according to published reports.

The FDA last December did not rule out the possibility that if Avastin is actually revoked, approval could be restored for certain sub
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