U.S., Europe Differ On Use Of Avastin

FDA plans to remove the breast cancer indication for Genentech’s Avastin after concluding the drug is not safe and effective for that use. In contrast, the European Medicines Agency has concluded that the benefits of Avastin outweigh its risks. The determinations, both announced on Dec. 16, are for Avastin with paclitaxel. Genentech, a Roche unit, says it will request a hearing to contest FDA’s decision. FDA approved the Avastin-paclitaxel combination for breast cancer in February 2008 under an accelerated approval program. With sales last year of about $6.7 billion, Avastin is Roche’s biggest-selling drug, although breast cancer is just one of several indications.