FDA Panel Rejects Breast Cancer Drug

Uncertainties on risk sink bid to expand uses for Avastin
By Sam Gale Rosen,  Newser Staff
Posted Dec 5, 2007 4:34 PM CST
FDA Panel Rejects Breast Cancer Drug
The Genentech Inc. headquarters are seen in South San Francisco, Calif., in this July 10, 2006 file photo. (AP Photo/Paul Sakuma, file)   (Associated Press)

An FDA panel rejected a drug to treat advanced breast cancer by 5-to-4 vote, the Wall Street Journal reports. The drug Avastin is already used to treat colon and lung cancer, but the panel said it did not have sufficient data to weigh the risks and benefits of using the drug to treat breast cancer.

The FDA isn't required to follow the panel's recommendation, the Journal notes, but it usually does. One panelist, who voted against Avastin, said she saw too many issues with the data Genentech presented. "I think there are other agents out there that are available for this patient population," she said. Avastin is Genentech's second-best-selling drug, with sales of $1.7 billion in 2006. (More Genentech stories.)

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