Additional indication for Novartis' Afinitor in Europe

Swiss pharma giant Novartis’ (NOVN: VX) Afinitor (everolimus) has been approved by the European Commission for an additional indication.

The EC has now cleared Afinitor for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease.This approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on April 29.

This approval helps address an unmet need for an underserved community with rare cancers that are associated with poor prognoses as there are currently few or no approved treatment options for patients with advanced progressive nonfunctioning GI and lung NET. Afinitor is the first approved therapy in all 28 member states of the European Union for this type of lung NET, and the first oral therapy for this type of GI NET.