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The Food and Drug Administration announced that Genentech Inc.'s drug Avastin failed to help breast cancer patients live longer and had serious side effects, including deaths. The results of a clinical trial showed that the drug failed to extend overall survival, although it did meet its primary goal of extending "progression-free survival."
Among the 722 patients in the study, those in the Avastin group had a 20 percent increase in serious toxicity, including hypertension, blood clots, and heart attacks, among other side effects. Thus, the FDA will ask an outside panel of medical experts whether the drug should be approved as a breast-cancer treatment.
You can read more on FDA's website.
Avastin (active ingredient: bevacizumab), a monoclonal antibody against vascular endothelial growth factor, showed encouraging results in patients with the most aggressive form of brain cancer, Genentech announced in mid-November. The announcement came after a successful Phase II trial in which bevacizumab showed clear improvements of the patients' survival rate.
Bevacizumab was developed by Genentech and is marketed in the United States by Genentech and elsewhere by Roche, which is Genentech's parent company, under the brand name Avastin. Bevacizumab, approved by the Food and Drug Administration (FDA) in February 2004 for use in colorectal cancer, was the first commercially available angiogenesis inhibitor. This class of drugs stops tumor growth by preventing the formation of new blood vessels. The main side effects of the drug are hypertension and heightened risk of bleeding.
Avastin is the company's second-biggest seller with $1.75 billion in sales in 2006.
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