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Phase III Trial of Novartis Drug Afinitor® Met Primary Endpoint of Reducing SEGA Tumor Size in Patients With Tuberous Sclerosis
Date:7/7/2011

inal tract (29%), allergic rhinitis (29%), acne-like skin inflammation (25%), pharyngitis or inflammation of the pharynx (25%), vomiting (25%), abnormal behavior (21%), cough (21%), dry skin (21%), scratching of the skin (21%), external ear infection (21%) and skin infection (21%). The most common Grade 3 AEs (with an incidence of at least 5%) were stomatitis or mouth sores, convulsion and decreased neutrophil count. In addition, single cases of Grade 3 sinusitis, pneumonia, viral bronchitis, gastroenteritis or inflammation of the gastrointestinal tract, limb abscess, aspiration, cyclic neutropenia, post lumbar puncture syndrome, sleep apnea syndrome and dizziness were reported. A single case of Grade 4 convulsion was reported. Adverse events were mostly Grade 1 (mild) or Grade 2 (moderate) in severity and were consistent with those previously reported at six months(11).

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. Everolimus is approved in Switzerland as Votubia® (everolimus) tablets for the treatment of patients three years of age and older, with SEGA associated with TS, for whom surgery is not a suitable option. Should everolimus be approved in the EU, the trade name will be Votubia.

Afinitor is approved in the US and Switzerland for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib and also in the EU for the treatment of patients with advanced RCC whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.

Afinitor is approved in the US f
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SOURCE Novartis Pharmaceuticals Corporation
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