Novartis drug Afinitor® recommended by CHMP for European Union approval to treat select GI and lung neuroendocrine tumors

Novartis International AG / Novartis drug Afinitor® recommended by CHMP for European Union approval to treat select GI and lung neuroendocrine tumors . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• If approved, Afinitor would be first treatment in EU indicated for advanced progressive, nonfunctional lung NET and first oral therapy for this type of GI NET
• Advanced, progressive, nonfunctional GI and lung neuroendocrine tumors (NET) are rare cancers with limited treatment options and poor outcomes[1,[2]

CHMP positive opinion based on pivotal study showing everolimus significantly improved PFS and reduced risk of progression vs placebo[3]

Basel, April 29, 2016 - Novartis today 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.

"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," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs.

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[1],[4]. NET can be defined as functional or nonfunctional[5]. 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[5],[6],[7],[8]. In contrast, functional NET are characterized by symptoms caused by the oversecretion of hormones and other substances[5]. 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[1],[4]. Progression, or the continued growth or spread of the tumor, is typically associated with poor prognoses[9].