sterolemia of grade 2 or
higher, compared with interferon-alpha (P=0.001), but there was not a
significant increase in hyperlipidemia versus interferon-alpha (P=0.675).
However, the development of hyperglycemia or hypercholesterolemia did not
have affect on overall survival or progression-free survival in this study.
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.
About 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.
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
carefully observed for the occurrence of infections, including
opportunistic infections.
Cases of interstitial lung disease, some resulting in death,
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SOURCE Wyeth Pharmaceuticals Copyright©2008 PR Newswire. All rights reserved | |
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