The FDA has approved everolimus (Afinitor®) tablets for the treatment of progressive neuroendocrine tumours of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease.

The approval was based on phase III data from the RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors) trial, showing treatment with everolimus was associated with better progression-free survival (11.0 vs. 4.6 months; hazard ratio, 0.35; 95% CI, 0.27 to 0.45; P<0.001). With regards to carcinoid tumours, the FDA determined that safety and effectiveness of everolimus had not been established in this setting.