Ipsen (Euronext: IPN; ADR: IPSEY) today announced that Somatuline® Depot® (lanreotide) Injection 120 mg (referred to as Somatuline®) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated: “I am pleased with the approval by the FDA of this new indication for Somatuline®, which is a testimony to the scientific quality of those clinical results. Ipsen is now prepared to launch in the US the first antitumor therapeutic approved for the treatment of both pancreatic and gastrointestinal neuroendocrine tumors. This represents a significant step forward in the treatment of this cancer, which affects thousands of Americans. In the US, we have diligently built a robust commercial organization that will execute on the launch of Somatuline® in this indication in early 2015.” Marc de Garidel concluded: “Today marks a major strategic milestone in our history, as we are now in a position to fully leverage our presence in the US.”
Pr Martyn Caplin, Professor of Gastroenterology & Gastrointestinal Neuroendocrinology, Royal Free Hospital (London, UK) and Principal Investigator of CLARINET®, commented: “Somatuline® has shown substantial clinical benefit in treating both pancreatic and gastrointestinal neuroendocrine tumors and can be considered as a first line therapy in the treatment of those tumors. This rapid approval from the FDA is welcome news for NET patients, their families and the whole NET community. I am looking forward to further regulatory approvals around the world so that patients with pancreatic and gastrointestinal neuroendocrine tumors can have access to this effective and well tolerated therapy.”
Somatuline® was previously approved in the United States for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
Somatuline®’s approval was based on demonstration of improved progression-free survival (PFS) in CLARINET® multi-center, international, randomized (1:1), double-blind, placebocontrolled study that enrolled 204 patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic, non-functioning GEP-NETs. Patients were randomized to receive either Somatuline® (lanreotide) 120 mg or placebo subcutaneously every 28 days. The primary efficacy endpoint was PFS as determined by independent central radiology review. The trial demonstrated a significant prolongation of PFS for the Somatuline® (lanreotide) arm [HR 0.47 (95% CI: 0.30, 0.73); p < 0.001; stratified log-rank test]. The median PFS in the Somatuline® (lanreotide) arm had not been reached at the time of the final analysis and therefore is greater than 22 months. The median PFS in the placebo arm was 16.6 months. Safety data were evaluated in 101 patients who received at least one dose of Somatuline® (lanreotide). The most commonly (greater than or equal to 10%) reported adverse reactions in Somatuline® (lanreotide)- treated patients were abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis. The most common serious adverse reaction of Somatuline® (lanreotide) observed in this trial was vomiting (4%).
The recommended dose and schedule for Somatuline® (lanreotide) for GEP-NET is lanreotide 120 mg administered by deep subcutaneous injection every 28 days. Treatment should continue until disease progression or unacceptable toxicity.