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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

ion please visit www.pfizer.com.

About Torisel® (temsirolimus)

Torisel is the only intravenous mammalian target of rapamycin (mTOR) inhibitor approved for the treatment of advanced renal cell carcinoma (RCC).

Based on preclinical studies, Torisel inhibits the activity of mTOR, an intracellular protein implicated in multiple growth-related cellular functions including proliferation, growth and survival.  The inhibition of mTOR also reduces levels of certain growth factors, such as vascular endothelial growth factor (VEGF), which are overexpressed in solid tumors like kidney cancer and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, nutrients and oxygen needed for growth.

Important Torisel® (temsirolimus) Safety Information

Torisel is contraindicated in patients with bilirubin >1.5 times the upper limit of normal (ULN).  If Torisel must be given to patients with mild hepatic impairment, it should be used with caution and at a reduced dose.

Torisel has been associated with serious and sometimes fatal side effects including: hypersensitivity reactions, hyperglycemia/glucose intolerance, infections, interstitial lung disease, hyperlipidemia, bowel perforation, renal failure, wound healing complications, and intracerebral hemorrhage.

Live vaccines and close contact with those who received live vaccines should be avoided.  Women of childbearing potential should be advised of the potential hazard to the fetus and avoid becoming pregnant.

The most common adverse reactions (incidence greater than or equal to 30%) are rash, asthenia, mucositis, nausea, edema, and anorexia.  The most common laboratory abnormalities (incidence  greater than or equal to 30%) are anemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, elevated alkaline phosphatase, elevated serum creatinine, lymp
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SOURCE Pfizer Inc.
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