FDA Approves Lanreotide Injection for Gastroenteropancreatic Neuroendocrine Tumors
The U.S. Food and Drug Administration (FDA) today approved lanreotide (Somatuline Depot Injection) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors. Lanreotide was previously approved 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.
Improved Progression-Free Survival
The approval was based on demonstration of improved progression-free survival in a multicenter, international, randomized, double-blind, placebo-controlled study that enrolled 204 patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic, nonfunctioning gastroenteropancreatic neuroendocrine tumors. Fifty-five percent of patients (113/204) had neuroendocrine tumors arising outside the pancreas. Patients were randomly assigned to receive either lanreotide 120 mg or placebo subcutaneously every 28 days.
The primary efficacy endpoint was progression-free survival as determined by independent radiology review. The trial demonstrated a significant prolongation of progression-free survival for the lanreotide arm (hazard ratio [HR] = 0.47, 95% confidence interval [CI] = 0.30–0.73), P < .001, log-rank test). The median progression-free survival in the lanreotide arm had not been reached at the time of the final analysis and will exceed 22 months. The median progression-free survival in the placebo arm was 16.6 months.
Safety data were evaluated in 101 patients who received at least one dose of lanreotide. The most commonly (≥ 10%) reported adverse reactions in lanreotide-treated patients were abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis. The most common serious adverse reaction of lanreotide observed in this trial was vomiting (4%).
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