Novartis' Afinitor approved in EU for advanced pancreatic neuroendocrine tumors

The European Commission has approved Swiss drug major Novartis’ (NOVN: VX) Afinitor (everolimus) tablets for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumors (NET) of pancreatic origin in adults with progressive disease. The decision applies in all 27 European Union member states, plus Iceland and Norway. Additional regulatory submissions for everolimus in advanced NET are under way worldwide.

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 Tumors) trial showed treatment with Afinitor more than doubled the time without tumor 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.

Afinitor is already cleared for renal cell carcinoma. In the USA it is available to treat patients with subependymal giant cell astrocytoma (SEGA) and has recently been approved for the pancreatic tumor indication by the Food and Drug Administration. The drug generated second-quarter sales of $102 million (+72% at constant exchange rates over the previous year’s quarter. According to a Thomson Reuters forecast, the drug is expected to bring in sales of $1.3 billion in 2015.