Ipsen announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Somatuline Depot 120 mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
In the European Union, Ipsen has submitted national marketing authorization variations for Somatuline Autogel 120 mg injection to the drug regulatory authorities in 25 countries of the European Union.
Following EU and US submissions, Ipsen intends to implement worldwide submission roll-out.
Regulatory submission is supported by the results of the CLARINET Phase 3 study, which demonstrated the antiproliferative effect of Somatuline in the treatment of patients with GEP-NETs. The data from CLARINET showed that investigational treatment with Somatuline substantially prolonged time to disease progression or death versus placebo (hazard ratio 0.47, p=0.0002). Safety data generated from the CLARINET study were consistent with the known safety profile of Somatuline.
Marc de Garidel, chairman and chief executive officer of Ipsen stated: “There are significant unmet medical needs among GEP-NET patients and Ipsen is committed to help address them. The submission of supplemental marketing authorization applications in the US and variations in Europe for Somatuline is evidence of our commitment to targeted oncology, and we are pleased to be able to submit them in our planned timeframe.”
The data from CLARINET is purely investigational, as Somatuline is not authorized for the indication of antiproliferative treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in any market. In many countries where it is marketed as Somatuline Autogel, Somatuline is approved for treatment of acromegaly and for the symptoms associated with neuroendocrine tumors, which can include the treatment of GEP-NET patients experiencing symptoms from carcinoid syndrome, and Somatuline is approved in many countries for the treatment of acromegaly. Somatuline Depot is approved in the US for the treatment of acromegaly but not for the treatment of GEP-NETs or the symptoms thereof.
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are serious and rare types of cancer. They constitute an heterogeneous group of tumors most often arising from cells in the gastrointestinal tract and the pancreas; although rare, their incidence has been on the rise (4-6 fold increase in the last 30 years). They have the ability to secrete functional amines and peptides and based on the type and amount of these bioactive substances in circulation, they can or cannot result in an identifiable hormonal clinical syndrome. GEP-NETs can be clinically silent for long periods of time, delaying the diagnosis until late presentation with hormonal related symptoms or with symptoms related to tumor mass effect such as intestinal obstruction or abdominal pain.
Date: July 1, 2014