FDA fast-tracks approval process for Sutent

NEW YORK — Pfizer announced Aug. 10 that it has submitted a new drug application for its cancer medicine SU11248 (sunitinib malate), known as Sutent, to the United States Food and Drug Administration. Pfizer is seeking FDA approval for Sutent as a treatment for gastrointestinal stromal tumor and metastatic renal cell carcinoma among patients whose tumors do not respond to or do not tolerate standard treatment. The FDA has granted Sutent “fasttrack” 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 antiangiogenic and anti-tumor activity to simultaneously stop the blood supply to and directly attack tumor cells.