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FDA Panel Rejects Avastin for Breast Cancer
Date:6/30/2011

ized on Tuesday. Genentech officials also defended E2100, the original study that formed the basis for the FDA's accelerated approval, and said there were no better treatments available for many women, CNN reported.

Lichtenfeld, at the end of the first day of hearings, outlined the dilemma. "Clearly, we are in a place where emotion meets science and the FDA's decision will prove to be a difficult one," he said in his blog.

The advisory panel's vote is non-binding, and FDA commissioner Margaret Hamburg will make a final ruling, the Associated Press reported.

The FDA's unusual step of scheduling another hearing on the drug underscored the difficulty of withdrawing approval of a cancer medication, the AP reported.

"It says to me that either they [the FDA] have gotten a great deal of negative feedback from various quarters, or there's some kind of internal disagreement within the agency," Dr. Gary Lyman, professor at the Duke Cancer Institute in North Carolina, told the news service. Lyman was part of the FDA advisory panel that voted 12-1 last year to revoke Avastin's approval as a breast cancer therapy.

The FDA's December recommendation did not immediately affect breast cancer patients' access to the drug or limit use of Avastin (bevacizumab) for advanced colon, lung, kidney and brain cancer.

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. Avastin costs more than $8,000 a month, according to published reports.

Avastin was OK'd in 2008 for use in metastatic breast cancer in conjunction with chemotherapy under the FDA's accelerated approval program. Approval was based on a clinical trial of patients with metastatic HER2-negative breast cancer that found a benefit in terms of cancer recurrence -- but not overall survival -- and was contingent on further dat
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