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Pfizer Announces Positive Phase 3 Trial Results for Axitinib in Patients With Previously-Treated Metastatic Renal Cell Carcinoma (mRCC)
Date:11/19/2010

olid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth.  Sutent also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.

Important Sutent® (sunitinib malate) Safety Information

Hepatotoxicity has been observed in clinical trials and post-marketing experience.  This hepatotoxicity may be severe, and deaths have been reported.  It is recommended to monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated.  Sutent should be interrupted for Grade 3 or 4 drug-related hepatic adverse 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 including full prescribing informat
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SOURCE Pfizer Inc.
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