The FDA has revoked its previous accelerated (and conditional) approval for bevacizumab (Avastin, Genentech) for the treatment of metastatic breast cancer (MBC), citing safety concerns that outweigh its benefits in this patient population. After reviewing the postapproval clinical trial data, FDA Commissioner MargaretA.Hamburg,MD, concluded that “it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects, without proof that the use of Avastin will provide a benefit.” Bevacizumab’s associated adverse effects include severe hypertension, bleeding and hemorrhaging, heart attack or heart failure, and gastrointestinal perforations. The drug received accelerated approval in 2008 for use in combination with paclitaxel for the treatment of HER2-negative MBC in patients who had not previously received chemotherapy based on demonstrated improved progression-free survival (PFS) but not improved overall survival (OS). New results from 2 postapproval studies showed that the drug had only a small effect on breast cancer tumor growth, without dem onstrating improved OS or that patients had a better quality of life than those receiving chemotherapy alone. The FDA’s end point for complete (as opposed to accelerated) drug approval relies on OS data, not on PFS alone. Bevacizumab’s other indications, for the treatment for certain types of colon, lung, kidney, and brain cancers, are not affected by this decision. (November 18, 2011)
