The clinical data for TORISEL presented at the meeting represent only a portion of the totality of the safety and efficacy data from the ongoing clinical development of TORISEL.
TORISEL is an mTOR inhibitor. Inhibition of mTOR in treated cancer cells blocked the translation of genes that regulate the cell cycle. In in vitro studies using renal cancer cell lines, TORISEL inhibited the activity of mTOR and resulted in reduced levels of certain cell growth factors involved in the development of new blood vessels, such as vascular endothelial growth factor.
TORISEL is approved for the treatment of advanced RCC in the United States, European Union and other markets, based on results of a phase 3 clinical study that demonstrated that TORISEL improves overall survival for patients with advanced RCC compared with interferon-alpha.
An application for the use of TORISEL for the treatment of relapsed and/or refractory MCL is currently under review with the European Medicines Agency (EMEA). TORISEL received Orphan Medicinal Product designation for the treatment of MCL in the European Union in November 2006.
Important Safety Information
Hypersensitivity reactions manifested by symptoms, including, but not limited to anaphylaxis, dyspnea, flushing and chest pain have been observed with TORISEL.
Serum glucose, serum cholesterol and triglycerides should be tested before and during treatment with TORISEL.
The use of TORISEL is likely to result in hyperglycemia and hyperlipemia. This may result in the need for an increase in the dose of, or initiation of, insulin and/or oral hypoglycemic agent therapy and/or lipid-lowering agents, respectively.
The use of TORISEL may result in immunosuppression. Patients should be
|SOURCE Wyeth Pharmaceuticals|
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