Once on 'Fast Track:Avastin Now Derailed

摘要

A unanimous vote last week by advisers to the U.S. Food and Drag Administration (FDA) is likely to sharply curtail access in America to the breast cancer drug Avastin, exposing deep rifts among patient advocates, researchers, and regulators over what kind of scientific backing a drug needs to remain in use. Avastin was approved for breast cancer in early 2008 under FDA's accelerated approval process. The process was designed to get promising drags to very sick patients quickly, but FDA acknowledges that those drugs also run the risk of later failing to live up to their promise. That's what happened with Avastin. Two large follow-up studies with about 2000 women showed only a sliver of benefit compared with earlier, more compelling results. And all the studies recorded serious health risks, including heart problems and fatal gastrointestinal perforations. In December, FDA announced that it was revoking Avastin's breast cancer approval, a rare but not unprecedented move for a fast-tracked drag. What was unprecedented was what came next: protests by Avastin's maker, the California company Genentech, which sought a reversal.