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Novartis highlights extensive data on numerous compounds at ASCO in multiple cancers, including Phase III studies in GIST and myelofibrosis
Date:5/31/2011

tiple myeloma and bone metastases from solid tumors should be taking an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.

Please see full Prescribing Information and talk to your doctor for more information.

About AFINITOR (everolimus)AFINITOR® (everolimus) tablets is approved in the US for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. The safety and effectiveness of AFINITOR in the treatment of patients with carcinoid tumors have not been established.

AFINITOR is approved in the US for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib and in the European Union (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 also approved in the US to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of AFINITOR 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. In Switzerland, everolimus is approved with the trade name Votubia® (everolimus) tablets for the treatment of patients 3 years of age and older with SEGA associated with tuberous sclerosis for whom surgery is not a suitable option. Novartis has submitted marketing applications for everolimus for this use to the European Medicines Agency (EMA) and additional regulatory submissions are under way worldwide.

AFINITOR is available in the US in 2.5 mg, 5 mg and 10 mg tablet strengths.

In the US, everolimus is available in different dosage strengths for
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SOURCE Novartis Pharmaceuticals Corporation
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