FDA approves first therapy for treating patients with GEP-NETs

December 18, 2014

FDA has approved lanreotide (Somatuline Depot, Ipsen) Injection, 120 mg (referred to as Somatuline) for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

FDA has approved lanreotide (Somatuline Depot, Ipsen) Injection, 120 mg (referred to as Somatuline) for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

"The use of somatostatin analogs remain the mainstay in treatment of NETs,” said Clarence D. Moore, PharmD, BCSP, assistant professor, Howard University College of Pharmacy in Washington, D.C. “FDA's expanded approval of Somatuline provides us with more options and further insight of these agents' efficacy."

Pancreatic and gastrointestinal neuroendocrine tumors are rare cancers. It is estimated that 112,000 individuals are currently living with pancreatic and gastrointestinal neuroendocrine tumors in the United States, and the incidence and prevalence of this type of cancer have risen 4-to-6 fold in the last 30 years. Up to 90% of patients are diagnosed at a late stage.

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.

The drug’s approval was based on demonstration of improved progression-free survival (PFS) in CLARINET multicenter, international, randomized (1:1), double-blind, placebo-controlled study that enrolled 204 patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic, non-functioning GEP-NETs. Patients were randomly assigned to receive either Somatuline 120 mg or placebo subcutaneously every 28 days. The primary efficacy end point was PFS as determined by independent central radiology review. The trial demonstrated a significant prolongation of PFS for the Somatuline arm [HR 0.47 (95% CI: 0.30, 0.73); P<.001; stratified log-rank test]. The median PFS in the Somatuline 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 1 dose of Somatuline. Commonly reported adverse reactions in Somatuline-treated patients were abdominal pain, musculoskeletal pain, vomiting, headache, injection-site reaction, hyperglycemia, hypertension, and cholelithiasis. The most common serious adverse reaction of Somatuline observed in this trial was vomiting (4%).

Recommended dose and schedule for Somatuline for GEP-NET is lanreotide 120 mg administered by deep subcutaneous injection every 28 days. Treatment should continue until disease progression or unacceptable toxicity.

“The approval of Somatuline offers the promise of increase survival for patients diagnosed with pancreatic or gastrointestinal neuroendocrine tumors. In addition, the approval of an anti-tumor agent demonstrates the progressive nature and willingness of FDA to provide the public with drugs that have the potential to improve quality of life or prove to be life-saving,” said Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.