European Commission approves Afinitor (everolimus)to treat metastatic, well-differentiated nonfunctional neuroendocrine tumours (NET) of gastrointestinal or lung origin.-Novartis

Novartis announced that the European Commission has approved Afinitor (everolimus) tablets for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumours (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease. Afinitor is the first approved therapy in all 28 member states of the European Union (EU), plus Iceland and Norway, for this type of lung NET, and one of very few treatment options available for this type of GI NET.

Neuroendocrine tumours 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 tumour 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 tumour 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 tumour, is typically associated with poor prognoses.

The EU approval of Afinitor was based on efficacy and safety data from a pivotal Phase III study (RADIANT-4) evaluating Afinitor versus placebo in patients with advanced, progressive, well-differentiated nonfunctional NET of GI or lung origin. Results showed that Afinitor reduced the risk of disease progression by 52% (hazard ratio = 0.48; 95% confidence interval [CI], 0.35-0.67; p<0.00001) compared to placebo. The data also showed Afinitor increased median progression-free survival (PFS) by 7.1 months: median PFS by central review was 11.0 months (95% CI, 9.2-13.3) in the Afinitor arm and 3.9 months (95% CI, 3.6-7.4) in the placebo arm .