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FDA commissioner Dr. Margaret A. Hamburg on Friday revoked approval of Avastin, a drug used for the treatment of breast cancer, saying that it is neither safe nor effective at treating the disease.
Her decision confirms a unanimous recommendation by an FDA advisory panel in June.
In a statement, Hamburg explained the decision: "After reviewing the available studies 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, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life."
As Bloomberg notes, Avastin is the world’s best-selling drug intended to treat cancer. According to the FDA statement, the drug is still approved for treatment of some types of colon, lung, kidney and brain cancer. The revoked approval means that, while doctors can still use the drug "off-label" for treatment of breast cancer, insurance companies may no longer pay for it, the New York Times reports.
Avastin was approved in 2008 in an "accelerated approval" program, which allows potentially life-saving drugs to be approved while still in clinical trials. As the Times notes, the issue is emotionally charged: Some patients claim that the drug is the only reason they’re still alive, and that the revocation amounts to a death sentence.
The paper explains that the issue is politically charged as well: "The revocation risked subjecting the Obama administration to criticism of being cruel. In addition, some Republicans had cited the possible action as an example of rationing under health care reform."
According to the American Cancer Society, an estimated 230,480 people will be diagnosed with invasive breast cancer in 2011. 39,520 people will die from breast cancer in the same period. Almost all of those people will be women, with about 2,000 cases of breast cancer expected to be in men this year.