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FDA Panel Supports Pfizer, Novartis Pancreatic Drugs

April 13, 2011
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A Food and Drug Administration panel of experts has recommended expanding the approved use of two drugs made by Novartis AG and Pfizer Inc. to include treating a rare type of pancreatic cancer, according to the Associated Press. Novartis AG said that the panel voted unanimously to recommend approving its drug Afinitor for patients with advanced neuroendocrine tumors originating in the pancreas. Afinitor is already approved as a treatment for advanced kidney cancer and a type of a rare genetic disorder called tuberous sclerosis, which causes tumors in the brain, eyes, lungs, liver and other organs. The drug had sales of $243 million in the U.S. in 2010. Neuroendocrine tumors, or NET, are mostly found in the pancreas, gastrointestinal tract or lungs. There are currently limited treatment options for patients with the disease. When pancreatic NET becomes advanced, meaning the cancer has spread to other parts of the body, it is considered aggressive and difficult to treat. About 60 percent of pancreatic NET patients are diagnosed with advanced disease, and the five-year survival rate for these patients is 27 percent. Pfizer said the panel voted 8-2 to approve Sutent for treatment of pancreatic NET that cannot be surgically removed.

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