FDA committee votes in Afinitor’s favour
pharmafile | April 13, 2011 | News story | Research and Development, Sales and Marketing |
The FDA advisory committee has unanimously backed Novartis’ Afinitor for neuroendocrine tumours of pancreatic origin.
The recommendation comes from the phase III RADIANT-3 trial of Afinitor (everolimus) in patients with advanced neuroendocrine tumours (NET) of pancreatic origin.
This study showed a statistically significant improvement in progression-free survival with Afinitor compared to placebo.
The FDA is not obliged to follow the advise of its committees, but it is unusual for it to not follow the recommendation.
Hervé Hoppenot, president of Novartis Oncology, said: “We look forward to working with the FDA as it completes its review and we are encouraged by the advisory committee’s recommendation to approve everolimus for patients with advanced pancreatic NET.
“The study of everolimus in this patient population is an example of our commitment to identify targeted options for patients with critical unmet medical needs.”
The drug was originally given priority review status by the FDA for advanced NET of gastrointestinal (GI), lung or pancreatic origin.
But the FDA later revised this decision and Novartis was forced to amend its proposed indication for just advanced NET of pancreatic origin.
Priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists and accelerates the standard review time from 10 to six months.
Neuroendocrine tumours arise from cells that can produce and secrete a variety of hormones that regulate bodily functions.
These tumours can occur anywhere in the body but most are found in the pancreas, gastrointestinal tract or lungs.
Novartis has currently filed Afinitor as a treatment for advanced NET of GI, lung or pancreatic origin for worldwide regulatory approval.
Afinitor is already licenced in the US as a first line treatment for patients with benign brain tumours and in the EU for renal cancer in combination with Nexavar or Sutent.
Afinitor targets mTOR, a protein that acts as an important regulator of tumour cell division, blood vessel growth and cell metabolism.
Pre-clinical and clinical data have established the role of mTOR in the development and progression of several types of tumours, including advanced pancreatic NET, for which there are limited treatment options.
Ben Adams
