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Home Industry News Novartis announces EU approval of Afinitor

Novartis announces EU approval of Afinitor

6th August 2009

Novartis has received approval from the EU commission for its Afinitor (everolimus) tablets, which are used as a treatment for patients with advanced renal cell carcinoma.

The therapy is intended for such patients who have experienced disease progression during or after treatment with vascular endothelial growth factor-targeted therapy.

David Epstein, president and chief executive of Novartis’ oncology and molecular diagnostics divisions, said that the approval means that thousands of people across Europe now have the opportunity to follow a “clear treatment path”.

A number of European treatment guidelines have now been updated to take the recommendation into account, including the European Society for Medical Oncology and the European Organisation for Research and Treatment of Cancer.

The commission’s decision applies to all 27 EU states and the treatment is currently under regulatory review in Switzerland and a number of other countries.

Last month, Novartis’ Ilaris (canakinumab) treatment received a recommendation for approval in the EU as a treatment for cryopyrin-associated periodic syndrome.

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