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FDA panel backs Pfizer, Novartis pancreatic drugs

Tue, 04/12/2011 - 3:17pm
The Associated Press

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.

Novartis AG said Tuesday 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, Switzerland-based Novartis said.

Afinitor tablets, taken once a day, target mTOR, a protein that regulates the growth of tumor cells and the blood vessels that feed them.

Separately, Pfizer said the panel voted 8-2 to approve Sutent for treatment of pancreatic NET that cannot be surgically removed.

The drug was approved in December in Europe for the same use. Sutent is an oral drug that blocks molecules involved in the growth and spread of tumors.

In the U.S., Sutent is already approved as a treatment for kidney cancer and for tumors of the stomach, esophagus, and bowels that do not respond to other treatment. New York-based Pfizer is seeking additional approvals, but has reported unsuccessful trials in lung cancer and prostate cancer.

The FDA normally follows the advice of its expert panels, though it is not required to do so. Separate studies of both drugs showed that patients on Afinitor or Sutent lived longer without the disease progressing than those taking a placebo.

Shares of Novartis rose 7 cents to close at $55.26. Pfizer closed down 21 cents at $20.46.

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