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Published on 6 August 2009

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Afinitor approved in EU

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The European Commission (EC) has approved Afinitor (everolimus) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.

Nearly 40% of all RCC patients have advanced cancer at time of diagnosis, meaning that their tumors have spread outside of the kidneys. Standard initial treatment for these patients may include VEGF-targeted therapies. Prior to Afinitor, there were no proven treatment options for advanced RCC patients whose cancer progressed while on or after treatment with VEGF-targeted therapy.

“This approval means that across Europe thousands of patients with advanced kidney cancer now have the opportunity for a clear treatment path with Afinitor if their disease progresses after treatment with a targeted therapy,” said David Epstein, President and CEO, Novartis Oncology, Novartis Molecular Diagnostics.

The EC based its approval of Afinitor on data from a pivotal phase III trial demonstrating that Afinitor, when compared with placebo, more than doubled the median time without tumor growth or death in patients with advanced kidney cancer whose disease progressed following prior VEGF-targeted therapy (4.9 vs. 1.9 months). Additionally, the data showed Afinitor reduced the risk of disease progression or death by 67% based on the primary endpoint of progression-free survival (PFS) (hazard ratio=0.33 with 95% confidence interval 0.25 to 0.43; P<0.0001).

Several European treatment guidelines have been updated to recommend Afinitor as a second-line advanced kidney cancer therapy after progression on targeted therapies, including those from the European Association of Urology (EAU), the Spanish Oncology Genitourinary Group (SOGUG), the European Organisation for Research and Treatment of Cancer (EORTC), the European Society for Medical Oncology (ESMO) and the UK Consensus Guidelines.

The EC decision applies in all 27 European Union (EU) member states. Afinitor is currently under regulatory review in Switzerland, Japan and other countries.

Novartis



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