FDA Approves Pfizer Drug Treating Stomach, Kidney Cancer
Posted on: Friday, 27 January 2006, 09:00 CST
FDA approves Pfizer drug treating stomach, kidney cancer
WASHINGTON, Jan. 26 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Thursday approved the Pfizer drug Sunitinib that treats a rare stomach cancer and advanced kidney cancer.
The FDA said the drug, to be sold under the name of Sutent, is the first cancer drug to simultaneously win its approval for two conditions.
Sutent, which received a priority review and was approved in less than six months, works by depriving tumor cells of the blood and nutrients needed to grow. It is meant to treat gastrointestinal stromal tumors (GIST) and advanced kidney cancer.
The FDA said Sutent should be used by GIST patients whose disease has progressed or who are unable to tolerate Gleevec, the current treatment for GIST patients. Studies show Sutent slows the growth of tumors in those patients.
The agency based its approval for Sutent in the treatment of patients with advanced renal cell carcinoma (RCC) on its ability to reduce the size of the tumors.
The FDA said it worked with Pfizer to make the drug available to patients not involved in the clinical trial before approval. Currently, more than 1,700 patients are being treated with the drug, it added.
The most commonly reported side effects of Sutent included diarrhea, skin discoloration, mouth irritation, weakness, and altered taste.
Source: Xinhua News Agency - CEIS
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