The US Food and Drug Administration (FDA) has approved everolimus (Afinitor, Novartis) for progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced, metastatic disease.
This oral kinase inhibitor that targets mTOR was approved based on the results of RADIANT-3, a phase 3 prospective, double-blind, randomized, parallel-group, placebo-controlled, multicenter trial. RADIANT-3 showed that treatment with everolimus prolonged time without tumor growth (median 4.6-11.0 months) and reduced the risk of cancer progression by 65% compared with placebo (HR, 0.35; 95% CI, 0.27-0.45; P <.001).
The FDA cautioned that everolimus’s safety and efficacy have not been established for carcinoid tumors.
Read the FDA release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm254350.htm.