Pfizer's Sutent Gets Approval

The Food and Drug Administration on Thursday approved a Pfizer (PFE) drug for treating advanced kidney cancer and a rare form of stomach cancer.

Although FDA approval had been expected for the drug Sutent, the announcement gave Pfizer a second dose of good news. Earlier in the day, the European Union approved Exubera, an inhaled form of insulin, developed by Pfizer and Nektar Therapeutics (NKTR).

The FDA might rule Friday on the companies' Exubera application in the U.S.

Sutent was reviewed and approved in less than six months. The drug, called a tyrosine kinase inhibitor, acts to deprive tumor cells of the blood and nutrients needed to grow, the FDA says.

Citing American Cancer Society data, the FDA says about 32,000 new cases of advanced kidney cancer and 5,000 cases of the rare stomach cancer -- gastrointestinal stromal tumors, or GIST -- are diagnosed each year. Sutent is approved for GIST patients who can't tolerate Gleevec from Novartis (NVS).

The FDA says clinical trials showed that Sutent delayed the time it takes for GIST tumors to grow and that the drug reduced the size of tumors in the kidney cancer patients.

Shares of Pfizer rose 22 cents to close regular trading at $25.05. The stock gained another 15 cents in after-hours action.

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