The FDA approval was given on the basis of RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors) Phase III trial data which showed that treatment with Afinitor more than doubled the time without tumor growth (median 4.6 to 11 months) and reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced pancreatic NET confidence interval (CI).
A consistent improvement in progression-free survival was seen with Afinitor in all patient subgroups.
Novartis Oncology president Herve Hoppenot said with this approval, US physicians can now offer their patients with progressive pancreatic NET a new treatment helping to fulfill a critical unmet need.
"This is the third indication for Afinitor in the US in just over two years, providing further evidence that inhibiting mTOR plays an important role in treating multiple tumor types," Hoppenot said.