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

By Amanda Gardner
HealthDay Reporter

TUESDAY, June 28 (HealthDay News) -- The controversial cancer drug Avastin becomes the focus of U.S. regulators' attention again Tuesday during a two-day hearing to determine if the medication can keep its FDA approval for the treatment of metastatic breast cancer.

Back on Dec. 16, the U.S. Food and Drug Administration recommended revoking approval of the drug to fight breast cancer, citing the medication's poor performance in follow-up studies and its potential for serious side effects.

The drug's maker, Genentech, now owned by the pharmaceutical giant Roche, was given the chance to appeal the FDA recommendation and present additional evidence. That appeal will be the focus of the hearing and, according to published reports, will involve Genentech urging one more clinical trial before any government action on the drug.

The FDA's unusual step of scheduling another hearing on the drug underscores the difficulty of withdrawing approval of a cancer medication, the Associated Press 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 July 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.

"FDA has taken the first step to removing the breast cancer indication from the label of the cancer drug Avastin," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, announced at the Dec. 16 news conference. "This is a first step in a process and will n
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