CHMP recommends Afinitor (everolimus) to treat neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin- Novartis

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-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease. If approved by the European Commission (EC), Afinitor would address an unmet need as there are currently few or no treatment options in Europe for patients with these diseases.

Neuroendocrine tumors are a type of cancer that originate in neuroendocrine cells throughout the body, and most commonly arise in the GI tract, lungs or pancreas. NET can be defined as functional or nonfunctional. The majority of patients with NET (72%) have nonfunctional NET, which are characterized by symptoms caused by tumor growth, such as intestinal obstruction, pain and bleeding for GI NET, and asthma, chronic obstructive pulmonary disease and pneumonia for lung NET. In contrast, functional NET are characterized by symptoms caused by the oversecretion of hormones and other substances. Five to 44% (depending on site of tumor origin) of those with GI NET and 28% of those with lung NET have advanced disease at time of diagnosis, meaning the cancer has spread to other areas of the body and patients face limited treatment options. Progression, or the continued growth or spread of the tumor, is typically associated with poor prognoses.

Comment: In February 2016, the FDA 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.