By Begley, Sharon
Newsweek , Vol. 156, No. 14
Byline: Sharon Begley
Why the FDA may reverse course on Avastin.
If the summer of 2009 was the season of "death panels," as the debate over health-care reform exploded, this is the season of "17.5k dead women a year." That's the body count scaremongers are predicting if the Food and Drug Administration rescinds its provisional approval of the drug Avastin for metastatic breast cancer, a decision expected by year's end. Although the move has nothing to do with the new health-care law, uncertainty about "Obama-care" has given opponents an opening to terrify people about what's coming--like bureaucrats rationing health care to save money, and killing Mom to do it.
The reality is far different and, for those who care more about helping cancer patients than about scoring political points, much sadder. That's because in 2008, when the FDA gave "fast track" approval for Avastin in breast cancer that has metastasized--usually to the lungs, bones, liver, or brain--it was conditional on the manufacturer, Genentech, running additional clinical trials of the drug's safety and efficacy. There was good reason for that. Avastin is an angiogenesis inhibitor, a class of cancer drugs that have not lived up to their hype: although they stop one mechanism by which malignant cells grow blood vessels to sustain them, the cells often activate a different mechanism and go on proliferating.
Although Avastin does extend the lives of patients with metastatic colorectal and kidney cancer, and remains FDA-approved for those uses, the new studies show it does not work the same miracle against metastatic breast cancer (MBC). Instead, Avastin increased what's called progression--free survival (how long before cancer spreads or grows) by about one to three weeks, depending on which chemo agent it was paired with. But it did not keep women alive any longer than chemo alone. To some advocates, progression--free survival without an increase in overall survival is still welcome, since it suggests patients have a better quality of life during their last months.
But it's hard to make that case for Avastin. Not only did it not keep women alive, but it also caused hypertension, hemorrhaging, bowel perforations, and other side effects. "It seems as if the drug's toxicity cancels out any benefit," cancer surgeon David Gorski of the Karmanos Cancer Institute told me. …