US Pharm. 2011;36(8):13.
Silver Spring, MD—The Oncologic Drug Advisory Committee (ODAC) unanimously recommended that FDA approval of Avastin (bevacizumab) for metastatic breast cancer be withdrawn due to safety and efficacy concerns. In December 2010, another FDA panel made a similar recommendation. The breast cancer indication was originally provided in February 2008 under the FDA’s accelerated approval program. The ODAC’s recommendation is not the final decision of the agency. FDA Commissioner Margaret A. Hamburg, MD, is expected to issue her ruling following the closing of the docket for public comment. Any decision will only affect the use of Avastin in relation to breast cancer; its indications for brain, colon, kidney, and lung cancers are not being challenged.
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