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Home Industry News Novartis receives CHMP recommendation for Afinitor

Novartis receives CHMP recommendation for Afinitor

26th July 2011

Novartis has been granted a recommendation for European regulatory approval of Afinitor, a treatment for patients with advanced pancreatic neuroendocrine tumours.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has backed the treatment for marketing authorisation based on positive phase III trial data, which showed the drug's efficacy compared to placebo.

Afinitor is an everolimus-based therapy for unresectable or metastatic, well or moderately-differentiated pancreatic neuroendocrine tumours and would be the first mTOR inhibitor drug to be approved for this patient group.

The European Commission is expected to follow the recommendation of the CHMP and will deliver its final decision within the next three months.

Herve Hoppenot, president for Novartis Oncology, said: "We are encouraged that this positive opinion may lead to an approval that will allow us to provide these patients with a new targeted treatment approach."

Last month, the company published positive data for Votubia, another everolimus-based treatment that utilises the compound to combat tuberous sclerosis complex.ADNFCR-8000103-ID-800633864-ADNFCR

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