Novartis Drug Afinitor Gains EU Approval

Novartis have today announced that the European Commission has approved Afinitor (everolimus) tablets for the treatment of unrespectable or metastatic, well- or moderately-differentiated neuroendocrine tumours (NET) of pancreatic origin in adults with progressive disease.

The approval was based on Phase III data from the largest clinical trial to date in advanced pancreatic NET.  The RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumours) trial showed treatment with Afinitor more than doubled the time without tumour growth (median 4.6 to 11.0 months) and reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced pancreatic NET (hazard ratio=0.35 [95% confidence interval (CI), 0.27 to 0.45]; p<0.001).  A consistent improvement in progression-free survival was seen with Afinitor in all patient subgroups, including patients who had not received prior chemotherapy.

Approximately 60% of pancreatic NET patients are diagnosed with advanced disease.  This means that the cancer has spread to other parts of the body, and is considered aggressive and difficult to treat.  The five-year survival rate for these patients is 27%.

Hervé Hoppenot, President, Novartis Oncology said that “today’s approval of Afinitor means that thousands of advanced pancreatic NET patients across Europe will have a new targeted approach for the treatment of this aggressive cancer type for which few therapeutic options are available”.  “We remain committed to the development of everolimus and to further researching the role of mTOR inhibition in multiple tumour types to address significant unmet medical needs for patients”.

Afinitor targets mTOR, a protein that acts as an important regulator of tumour cell division, blood vessel growth and cell metabolism.  Preclinical and clinical data have established the role of mTOR in the development and progression of several types of tumours, including advanced pancreatic NET.  Afinitor is the first mTOR inhibitor approved in the EU for the treatment of NET of pancreatic origin.

The decision applies in all 27 European Union member states, plus Iceland and Norway.  Additional regulatory submissions for everolimus in advanced NET are also under way worldwide.



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