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.