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Chicago
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Joined: Apr 2004

2006-01-26
FDA OKs Pfizer Stomach, Kidney Cancer Drug
AP

WASHINGTON (Jan. 26) - A Pfizer Inc. drug won speedy federal approval Thursday to combat a rare stomach cancer and advanced kidney cancer.

Sunitinib, to be marketed as Sutent, is the first cancer drug to simultaneously win Food and Drug Administration approval for two conditions, the agency said.

Sutent works by depriving tumor cells of the blood and nutrients needed to grow. The FDA granted the drug priority review and approved it just six months later.

It is meant to treat gastrointestinal stromal tumors, a rare stomach cancer also known as GIST, and advanced kidney cancer.

About 32,000 new cases of advanced kidney cancer and 5,000 cases of GIST are diagnosed each year, according to the American Cancer Society.

The FDA said Sutent should be used by GIST patients whose disease has progressed or who are unable to tolerate Gleevec, the drug currently used to treat the cancer. Studies show the drug slows the growth of tumors in those patients.

As for the other condition, the agency said the drug should be used in patients with advanced renal cell carcinoma, a kidney cancer. In their case, clinical trials showed the drug reduced the size of tumors.

FDA said it worked with Pfizer to make the drug more widely available even before approving it. More than 1,700 patients currently are being treated with the drug, the agency said.

Side effects included diarrhea, skin discoloration, mouth irritation, weakness,and altered taste.

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