CHMP’s decision was backed by the positive results of a Phase III RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors) trial which demonstrated that the patients with advanced pancreatic NET when treated with everolimus showed 65% reduction in the risk of cancer progression in comparison to placebo.
The RADIANT-3 Phase III double-blind, prospective, placebo-controlled, randomized, parallel group and multicenter study also showed consistent improvement in progression-free survival with everolimus in all patient subgroups, including those who had not received prior chemotherapy.
Novartis Oncology president Herve Hoppenot said this positive recommendation is an important milestone for patients in the European Union with advanced pancreatic NET who have a difficult to treat cancer and limited treatment options.
"We are encouraged that this positive opinion may lead to an approval that will allow us to provide these patients a new targeted treatment approach," Hoppenot said.