SUTENT, an oral, multi-targeted tyrosine kinase inhibitor, is being made available through a treatment use protocol that has been approved by health authorities globally, including the U.S. Food and Drug Administration (FDA).
"We are encouraged by the promising results SUTENT has demonstrated in clinical trials," said Dr. Charles Baum, M.D., Ph.D., Global Clinical Leader, Pfizer Oncology. "The initiation of this treatment use protocol allows us to bring SUTENT to kidney cancer patients who may benefit from the therapy."
To be eligible for the SUTENT treatment use protocol, patients must have a clinical diagnosis of cytokine-refractory metastatic renal cell carcinoma and have not previously participated in a SUTENT clinical study. The first sites have opened to enrollment in the U.S. and Canada with many more sites to open in August, September and October in additional locations worldwide. Patients enrolled in the open label study will be monitored and data will be gathered to further assess the safety and benefit of SUTENT in patients with metastatic renal cell carcinoma. To learn more about open trial sites, patients and their physicians are encouraged to call the SUTENT clinical trial information line at 1-877-416-6248 or to visit www.pfizeroncology.com.
"Kidney cancer has traditionally been a difficult cancer to treat, and to date there have been few options to offer patients with this deadly disease," said Bill Bro, President of the Kidney Cancer Association. "We are pleased that continued research efforts and new potential treatment options such as SUTENT are bringing hope to kidney cancer patients in need."
GIST Treatment Use Program Continues
In addition to kidney cancer, SUTENT has been studied in patients with Gleevec-resistant Gastrointestinal Stromal Tumor or GIST. In 2004, Pfizer initiated a global, SUTENT expanded access program for patients with Gleevec-resistant GIST. Patients seeking information regarding this program should call 1-877-416-6248 or to visit www.pfizeroncology.com. Early phase II studies also have been conducted in patients with advanced non-small cell lung cancer, breast cancer, neuroendocrine tumors and a number of other indications.
About SUTENT (sunitinib malate)
SUTENT is one of the first in a new class of drugs that selectively targets multiple protein receptors, called receptor tyrosine kinases (RTKs). SUTENT inhibits several important RTKs including vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), KIT, RET, and FLT3. 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.
SUTENT has not yet been approved by the U.S. Food and Drug Administration (FDA) or other global regulatory agencies. Pfizer submitted a New Drug Application with the FDA on August 10, 2005 for SUTENT as a treatment for malignant GIST 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 it may provide significant benefit over existing therapy for serious or life-threatening illnesses for which no therapy exists.
The most commonly reported adverse events in SUTENT clinical trials were generally mild to moderate in severity and reversible with dose delay, reduction or upon discontinuation of treatment. The most common treatment-related adverse events included fatigue, gastrointestinal upset (diarrhea, nausea, stomatitis, dyspepsia, and vomiting), skin discoloration, dysgeusia, and anorexia. The complete adverse event profile of SUTENT is not yet known.
About Pfizer Oncology
Pfizer Oncology is committed to advancing the scientific understanding of cancer and to bringing new medicines to address unmet medical needs in cancer patients. Oncology is a research priority for Pfizer, with a significant portion of the company's research and development investment devoted to discovering and developing innovative therapies for treating breast, colorectal and other cancers.
DISCLOSURE NOTICE: The information contained in this release is as of August 23, 2005. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about a potential product candidate which is under review by the U.S. Food and Drug Administration (FDA) that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by the FDA and other regulatory authorities regarding whether and when to approve drug applications that have been or may be filed for the product candidate as well as their decisions regarding labeling and other matters that could affect its commercial potential; and competitive developments.
A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2004 and in its reports on Form 10-Q and Form 8-K.