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Novartis Gains FDA Approval for Afinitor® as First New Treatment in Nearly Three Decades for Patients with Advanced Pancreatic NET
Date:5/5/2011

ndocrine 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.

For more information visit www.AFINITOR.com/pNET or call 1-888-4-AFINITOR. US patients who may be eligible for financial assistance can learn about the Patient Assistance Now Oncology (PANO) reimbursement support program by contacting 1-800-282-7630 or visiting the Afinitor website.

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. Novartis has submitted marketing applications for everolimus for this use to the European Medicines Agency (EMA) and the Swiss Agency for Therapeutic Products (Swissmedic), 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 the non-oncology patient population under the trade name Zortress® for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant. In the EU, everolimus is available in different
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SOURCE Novartis Pharmaceuticals Corporation
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