FDA Panel Says Avastin Should Not Be Used For Breast Cancer
August 11th, 2010
A Food and Drug Administration advisory committee on July 20, 2010 recommended that the approval of the drug Avastin used for the treatment of metastatic breast cancer be withdrawn. They concluded that new trials showed no apparent benefit from the drug.
The 12 to 1 vote represented a setback for Avastin, the world’s best-selling cancer drug, with sales last year of about $6 billion. Avastin is sold by drug maker Roche’s Genentech unit.
The action, if taken, would not affect marketing of the drug for brain, lung, colon and kidney cancer, but would prevent the manufacturer from promoting its use for breast cancer.
The 13 experts convened by the FDA voted unanimously that the drug’s side effects and risks outweighed benefits. The initial approval was based on a clinical trial in which Avastin, known generically as bevacizumab, was combined with the breast cancer drug paclitaxel in women with metastatic breast cancer. That trial showed that Avastin plus paclitaxel increased the time during which the therapy prevented progression of the disease by a little over five months compared with paclitaxel alone. The combination did not increase overall survival by a significant amount, however.
The new studies presented to the panel failed to confirm those initial findings. The progression-free survival improved by as little as a month and, again, overall survival did not improve. In fact, because of complications from the drug, survival was actually slightly less for some women. Patients did experience serious side effects, including fatigue, abnormal white blood cell counts and high blood pressure.
A study published in the Journal of the American Society of Nephrology found that the drug increases the risk of severe protein loss from the kidneys, a condition called proteinuria, which can lead to kidney damage. Researchers found that a little more than 2 percent of people taking Avastin developed severe proteinuria. Their risk for the condition was found to be almost five times higher than for patients receiving only chemotherapy. Proteinuria places a person at higher risk for blood clots and other complications on top of the risks related to cancer and chemotherapy. Proteinuria can lead to kidney failure if left untreated.
In a statement released Tuesday, Roche subsidiary Genentech, said it stood by the data it presented to the FDA and that it believed Avastin should continue to be an option for patients with this incurable disease.
The agency is expected to make a formal decision by Sept. 17. It is not required to follow the recommendations of advisory panels, but generally does.
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