Novartis drug Afinitor recommended by CHMP for EU approval to treat patients with advanced pancreatic neuroendocrine tumors
Phase III trial showed everolimus significantly delayed tumor growth in patients with advanced neuroendocrine tumors (NET) of pancreatic origin
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Afinitor® (everolimus) tablets for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumors (NET) of pancreatic origin in adults with progressive disease. If approved, everolimus will be the first mTOR inhibitor available for these patients.
"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," said Hervé Hoppenot, President, Novartis Oncology. "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."
The recommendation was based on Phase III data from the RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors) trial showing treatment with everolimus more than doubled the time without tumor growth (median 4.6 to 11.0 months) and reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced pancreatic NET (hazard ratio=0.35 [95% confidence interval (CI), 0.27 to 0.45]; p<0.001). A consistent improvement in progression-free survival was seen with everolimus in all patient subgroups, including those who had not received prior chemotherapy.
Everolimus targets mTOR, a protein that acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism. Preclinical and clinical data have established the role of mTOR in the development and progression of advanced pancreatic NET.
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