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Further EU approval for Novartis' Afinitor

Novartis' cancer therapy Afinotor has been granted an additional EU approval for use in the treatment of patients with an advanced form of pancreatic cancer

Novartis' cancer therapy Afinotor (everolimus) has been granted new European Union (EU) approval for use as a treatment for patients with an advanced form of pancreatic cancer.

The drug, which is also approved for patients with advanced renal cell carcinoma, can now be used as for the treatment of neuroendocrine tumours (NET) of pancreatic origin that have either spread to other parts of the body or cannot be removed by surgery. About 60 per cent of patients diagnosed with pancreatic NET have an advanced form of the disease.

The approval follows a phase III trial that showed Afinitor more than doubled the length of time patients went without tumour growth when compared with placebo.

The decision applies in all 27 EU member states, as well as Iceland and Norway.

Hervé Hoppenot, president of Novartis Oncology, said the decision would benefit thousands of patients across Europe who have limited therapy options.

Novartis is continuing to develop the drug for other forms of cancer.

5th September 2011

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