The approval is based on data from RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily), the largest Phase III clinical trial to study the effects of an oral mTOR inhibitor in advanced RCC patients whose cancer progressed despite prior VEGF-targeted treatment. In February 2008, based on a recommendation from an independent data monitoring committee, Novartis stopped the trial after interim results showed that patients receiving Afinitor experienced a significant delay in cancer progression or death compared with patients receiving placebo. This international, multicenter, randomized, double-blind clinical trial involved 416 patients with advanced RCC whose cancer progressed despite prior treatment with sunitinib or sorafenib. Prior therapy with bevacizumab, interferon alfa and interleukin-2 was allowed. Patients were randomized to receive Afinitor (10 mg) daily or placebo, in conjunction with best supportive care. The primary endpoint of the study was PFS, which was assessed via a blinded, independent, central radiological review. About RCC
Renal cell carcinoma, which accounts for approximately 2% of all new cancers, is often referred to as kidney cancer. The occurrence rates of RCC are rising steadily around the world due, in part, to smoking and obesity. In the EU, there were more than 63,000 new cases of RCC diagnosed and more than 26,000 people died from the disease in 2006. In RCC, cancer cells develop in the lining of the kidney's tubes and grow into a tumor. If left untreated, the tumor can spread to neighboring lymph nodes and eventually to other organs,. About Afinitor
In the EU, Afinitor is indicated for patients with advanced RCC whose disease progressed on or after treatment with VEGF-targeted therapy. Afinitor is also approved in the US to treat advanced RCC after failure of treatment with sunitinib or sorafenib. In cancer cells, Afinitor continuously targets mTOR, a protein that acts as a central regulator of tumor cell division, blood vessel growth and cell metabolism. Afinitor is being studied in multiple cancer types, including RCC, neuroendocrine, breast, gastric and hepatocellular carcinoma (HCC), as well as tuberous sclerosis complex (TSC) and non-Hodgkin's lymphoma. The active ingredient in Afinitor is everolimus, which is available in different dosage strengths under the trade name Certican® for the prevention of organ rejection in heart and kidney transplant recipients. Certican was first approved in the EU in 2003. For more information on Afinitor, visit www.afinitor.com. About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com. 1.The University of Texas MD Anderson Cancer Center. Kidney Cancer. Available at http://www.mdanderson.org/patient-and-cancer-information/cancer-information/cancer-types/kidney-cancer/index.html. Accessed June 2009.
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