Pfizer's Sutent Receives FDA Approval to Include New First-Line Advanced Kidney Cancer Data in Label

New Labeling Based on Efficacy Data from a Large Phase 3 Clinical Trial Which Showed Superiority of Sutent to Standard Therapy Across Key Endpoints

NEW YORK, NY, USA | Feb 08, 2007 |
Pfizer Inc said today that the U.S. Food and Drug Administration (FDA) has approved new labeling of Sutent® (sunitinib malate) which includes first-line treatment of advanced renal cell carcinoma (RCC), a type of advanced kidney cancer, based on results of a large Phase 3 trial which showed prolonged progression-free survival.

"Sutent is redefining the kidney cancer treatment landscape and is a promising option for patients and their families," said Dr. Charles Baum, vice president of Pfizer Global Research and Development. "We are committed to furthering our research of this innovative treatment in other patient groups such as breast and lung cancer, where improved treatments are needed."

Sutent was originally approved in January 2006 for the treatment of advanced kidney cancer under the accelerated approval provision, based on partial response rates and duration of response. With the new labeling, the accelerated approval has been converted to regular approval.

In a large, randomized Phase 3 trial, 750 treatment-naive patients with metastatic RCC received either Sutent or the comparator interferon-alfa (IFN infinity), the current standard of care. Key findings include:

* Patients taking Sutent achieved a median progression free survival of 11 months -- more than double the 5-month median progression free survival observed with IFN infinity;

* Sutent patients experienced a 5-fold higher objective response rate compared with IFN infinity in first-line RCC treatment (27.5% vs. 5.3%);

* Overall, Sutent was generally well tolerated with fewer discontinuations from treatment than IFN infinity. Fewer patients discontinued the medicine because of treatment-emergent non-fatal adverse events (9% vs. 12%).

These study results were published in the January 11, 2007 issue of The New England Journal of Medicine.

"For many years, the options available for people with metastatic kidney cancer have been very limited," said Dr. Robert Motzer, lead investigator of the Phase 3 trial and attending physician at Memorial Sloan-Kettering Cancer Center. "To have such a high percent of patients respond to this treatment is remarkable and a sign of the significant benefit Sutent may bring to patients fighting this deadly cancer."

Side effects for Sutent in this Phase 3 trial were generally mild or moderate. The most common treatment-related adverse events of any grade were fatigue, diarrhea, nausea, altered taste, mucositis/stomatitis, hypertension, anorexia and bleeding.

In addition to approval for first-line treatment of advanced RCC in the US, Sutent is also indicated for the treatment of gastrointestinal stromal tumors (GIST) after disease progression on or intolerance to imatinib mesylate.

About Renal Cell Carcinoma

Advanced renal cell carcinoma, or kidney cancer, is a relatively rare though serious disease and historically has been among the most therapy-resistant tumors. According to the American Cancer Society, the rate of people developing kidney cancer has been increasing every year for reasons that are currently not clear. In 2007, an estimated 51,190 new cases of kidney cancer will be diagnosed (31,590 in men and 19,600 in women) in the United States, and about 12,890 people (8,080 men and 4,810 women) will die from this disease.

Important Safety Information

Women of child bearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on Sutent.

Decreases in left ventricular ejection fraction (LVEF) to below the lower limit of normal (LLN) have been observed. Patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure.

Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. CBCs with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with Sutent.

For more information on Sutent please visit http://www.pfizer.com/.
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SOURCE: Pfizer Inc

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