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FDA Commissioner announces Avastin decision
Date:11/18/2011

Avastin's breast cancer indication. After the hearing, the public docket remained open until Aug. 4, 2011. (In an earlier meeting of the ODAC, that committee had voted 12-1 in favor of the removal of the breast cancer indication from the Avastin label).

"FDA is committed to working with sponsors to bring promising cancer drugs to market as quickly as possible using tools like accelerated approval," Dr. Hamburg said. "I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug."

For more information:

Avastin Decision
http://www.fda.gov/NewsEvents/Newsroom/UCM279485

FY2011 Innovative Drug Approvals
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm

Media Inquiries: Karen Riley, 301-796-4674,
Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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