Mar 31, 2009

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By JEANNE WHALEN

The U.S. Food and Drug Administration approved for sale a kidney-cancer drug that Novartis AG hopes to eventually expand to a variety of other cancers.

The drug, Afinitor, targets a protein in the body that appears to underlie more than half a dozen types of cancer, according to Novartis, which is testing the drug in most of these.

The head of Novartis's cancer business earlier this year said Afinitor could achieve annual sales of more than $1 billion if it is approved for more than one type of cancer.

The FDA approved Afinitor for use in advanced kidney-cancer patients who aren't responding to other drugs. Afinitor works by attacking the mTOR protein, which is involved in tumor-cell division and blood-vessel growth.

Afinitor is the second such drug to hit the market, behind Wyeth's Torisel, which is administered by weekly injection. Afinitor could have a marketing advantage in being a daily, oral pill.

In a phone interview, Novartis Chief Executive Daniel Vasella said Afinitor "has potential in many cancers." As a next step, he said, Novartis plans to seek regulatory approval to sell the drug for use in neuroendocrine tumors, which are rare and occur mostly in the digestive system.

Novartis is also testing Afinitor in gastric cancer, breast cancer, lymphoma, a type of liver cancer, and tuberous sclerosis, a rare genetic disease.

Other drug companies are also pursuing the mTOR protein and its connection to a host of cancers. Wyeth is attempting to broaden Torisel's use to a rare cancer of the lymphatic system, while Merck & Co. is working with Ariad Pharmaceuticals Inc. to develop a similar drug for several types of cancer.

Write to Jeanne Whalen at jeanne.whalen@wsj.com

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