NEW YORK, August 10 — Pfizer Inc said today that it has submitted aNew Drug Application for its cancer medicine SU11248 (sunitinibmalate), known as Sutent, to the U.S. Food and Drug Administration.

Pfizeris seeking FDA approval for Sutent as a treatment for malignantgastrointestinal stromal tumor and metastatic renal cell carcinomaamong patients whose tumors do not respond to or do not toleratestandard treatment options.

The FDA has granted Sutentfast-track status since Sutent may provide significant benefit overexisting therapy for serious or life-threatening illnesses for which notherapy exists.

Sutent is an oral, multi-targeted cancertherapy that combines anti-angiogenic and anti-tumor activity tosimultaneously stop the blood supply to and directly attack tumorcells. Over 2,000 patients have received Sutent as part of Pfizer’sclinical trial program.

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

Sutent is one of the firstin a new class of drugs that selectively targets multiple proteinreceptors, called receptor tyrosine kinases (RTKs). Inhibition of theseRTKs is believed to starve tumors of blood and nutrients needed forgrowth and simultaneously kill the cancer cells that make up tumors.

Pfizeris committed to advancing the scientific understanding of cancer and tobringing new medicines that address unmet medical needs to cancerpatients. Oncology is a research priority for Pfizer, with asignificant portion of the company’s research and developmentinvestment devoted to discovering and developing innovative therapiesfor treating breast, colorectal and other cancers.