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Pfizer Discontinues Phase 3 Trial of SUTENT® in Advanced Castration-Resistant Prostate Cancer
Date:9/27/2010

dverse events and discontinued if there is no resolution.  SUTENT should not be restarted if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure.

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.  Complete blood counts (CBCs) with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.

The most common adverse reactions in GIST and RCC clinical trials were diarrhea, fatigue, asthenia, nausea, mucositis/stomatitis, anorexia, vomiting, hypertension, dyspepsia, abdominal pain, constipation, rash, hand-foot syndrome, skin discoloration, altered taste and bleeding. For more information on SUTENT and Pfizer Oncology, including full prescribing information for SUTENT (sunitinib malate), please visit www.pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of September 27, 2010.  Pfizer assumes no obligation to update 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 additional indication for SUTENT, including its potential benefits, that involves substantial risks and uncertainties.  Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions
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SOURCE Pfizer Inc.
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