The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Novartis’ Afinitor (everolimus) tablets 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.

Neuroendocrine tumors are a type of cancer that originate in neuroendocrine cells throughout the body, and most commonly arise in the gastrointestinal (GI) tract, lungs or pancreas.

The European Commission typically adheres to the recommendation of the CHMP and delivers its final decision within three months. The decision will be applicable to all 28 European Union member states plus Iceland and Norway.

In February 2016, the US Food and Drug Administration approved Afinitor for the treatment of adult patients with progressive, well-differentiated, nonfunctional NET of GI or lung origin that are unresectable, locally advanced or metastatic. Additional worldwide regulatory filings for this indication are underway.

Afinitor (everolimus) tablets is approved in 99 countries, including the US and in the European Union, for locally advanced, metastatic or unresectable progressive NET of pancreatic origin. Afinitor is not indicated for the treatment of patients with functional carcinoid tumors in the US. Afinitor is now approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. It is also approved in more than 120 countries, including the US and European Union, for advanced renal cell carcinoma following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy (in the US, specifically following sunitinib and sorafenib). Additionally, Afinitor is approved in more than 100 countries, including the United States and European Union, for advanced HR+/HER2- breast cancer in combination with exemestane, after prior endocrine therapy.

Source: Novartis