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New Drug Application for Sunitinib Malate Submitted for Review

NEW YORK, Aug. 10 /PRNewswire-FirstCall/ -- Pfizer Inc said today that it has submitted a New Drug Application for its cancer medicine SU11248 (sunitinib malate), known as Sutent, to the U.S. Food and Drug Administration.

Pfizer is seeking FDA approval for Sutent as a treatment for malignant gastrointestinal stromal tumor and metastatic renal cell carcinoma among patients whose tumors do not respond to or do not tolerate standard treatment options.

The FDA has granted Sutent fast-track status since Sutent may provide significant benefit over existing therapy for serious or life-threatening illnesses for which no therapy exists.

Sutent is an oral, multi-targeted cancer therapy that combines anti- angiogenic and anti-tumor activity to simultaneously stop the blood supply to and directly attack tumor cells. Over 2,000 patients have received Sutent as part of Pfizer's clinical trial program.

Developed by Pfizer, Sutent also is being studied alone and in combination with other medicines as a treatment for a number of other solid tumors, including breast, lung, prostate, and colorectal cancers.

Sutent is one of the first in a new class of drugs that selectively targets multiple protein receptors, called receptor tyrosine kinases (RTKs). Inhibition of these RTKs is believed to starve tumors of blood and nutrients needed for growth and simultaneously kill the cancer cells that make up tumors.

Source: Pfizer Inc

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