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Novartis Drug Afinitor® Effective in Patients With Non-Cancerous Kidney Tumors Associated With TSC in Phase III Trial
Date:9/23/2011

orted more commonly in the placebo arm. During the study, one death in the everolimus arm occurred due to convulsion, though it was not considered related to the study drug by the investigator(1).

EXIST-2 enrolled 118 patients in the US, Germany, the Netherlands, Japan, the UK, Russia, Italy, Canada, Poland, Spain and France. This study is part of a Phase III trial program investigating everolimus in the various manifestations of TSC(1,10).

About everolimusIn the US, Afinitor® (everolimus) tablets is approved to treat patients with SEGA associated with TS who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of everolimus is based on an analysis of change in SEGA volume. Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been shown.

Afinitor is also approved in the US for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib and for the treatment of progressive neuroendocrine tumors of pancreatic origin (pNET) in patients with unresectable, locally advanced or metastatic disease. The US Food and Drug Administration (FDA) determined that the safety and effectiveness of Afinitor in the treatment of patients with carcinoid tumors have not been established.

In the US, everolimus is available from Novartis in different dosage strengths and for different uses in non-oncology patient populations under the trade name Zortress®. Everolimus is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.

Not all indications are available in every country. Access to everolimus outside of the approved indications has been carefully controlled and monitored in clinical trials designed to better understand the potential benefits and risks of the compound. As an investigational compound, the safety and efficacy profile o
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SOURCE Novartis Pharmaceuticals Corporation
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