On May 5, 2011, the FDA approved everolimus (Afinitor) for treatment of advanced unresectable or metastatic progressive neuroendocrine tumors of pancreatic origin.
The approval was based on a randomized comparison of everolimus at 10 mg orally/day versus placebo. The median progression-free survival (PFS) was 11.0 versus 4.6 months, respectively (p<0.001). This respresents a major advance for patients with this aggressive form of cancer, for which there were few treatment options.