The approval was backed by the results of RAD001 In Advanced Neuroendocrine Tumors (RADIANT-3) Phase III trial which demonstrated that the treatment with Afinitor more than doubled the time without tumor growth and reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced pancreatic NET.
The results of the trial showed consistent improvement in progression-free survival was seen with Afinitor in all patient subgroups, including patients who had not received prior chemotherapy.
Novartis Oncology president Herve Hoppenot said they remain committed to the development of everolimus and to further researching the role of mTOR inhibition in multiple tumor types to address significant unmet medical needs for patients.