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, Feb. 8 /PRNewswire-FirstCall/ -- Pfizer Inc said today that
the U.S. Food and Drug Administration (FDA) has approved new labeling of
Sutent(R) (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.

Link to this page:

  

http://www.prnewswire.com/comp/688250.html/
CONTACT:
Vanessa Aristide, of Pfizer Inc,
+1-212-733-3784

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