CHMP recommends Novartis drug Afinitor® for European Union approval


April 29, 2016

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

Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs, said: “This important milestone reinforces our long-standing commitment to the NET community by providing solutions to help improve outcomes for patients with these rare and difficult-to-treat cancers.”

Neuroendocrine tumors are a type of cancer that originate in neuroendocrine cells throughout the body, and most commonly arise in the GI tract, pancreas, or lungs. NET can be functional or nonfunctional. 72% of patients with NET have nonfunctional NET, which are characterized by symptoms caused by tumor growth, such as intestinal obstruction, pain and bleeding for GI NET, and chronic obstructive pulmonary disease, asthma, and pneumonia for lung NET. On the other hand, functional NET are characterized by symptoms caused by the oversecretion of hormones and other substances.

CHMP recommends Novartis drug Afinitor® for European Union approval last edit: 2016-05-05T17:02:21+00:00 da Luca

Leave a Reply

*The views and opinions expressed on IgeaHub belong to the authors only. They do not represent the views or opinions of any company or organization.

Follow Us

Join us

All rights reserved. Terms of use and Privacy Policy

Design by PT Webmaster

%d bloggers like this:
Skip to toolbar