FDA Approves Somatuline Depot (lanreotide) for Gastroenteropancreatic Neuroendocrine Tumors
December 16, 2014 -- The U. S. Food and Drug Administration has approved lanreotide (Somatuline Depot Injection, Ipsen Pharma) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. 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.
The approval was based on demonstration of improved progression-free survival (PFS) in a multi-center, international, randomized (1:1), double-blind, placebo-controlled study (Trial 2- 55-52030-726) that enrolled 204 patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic, non-functioning GEP-NETs. Fifty-five percent of patients (113/204) had neuroendocrine tumors arising outside the pancreas. Patients were randomized to receive either lanreotide 120 mg or placebo subcutaneously every 28 days.
The primary efficacy endpoint was PFS as determined by independent radiology review. The trial demonstrated a significant prolongation of PFS for the lanreotide arm [HR 0.47 (95% CI: 0.30, 0.73); p < 0.001; log-rank test]. The median PFS in the lanreotide arm had not been reached at the time of the final analysis and will exceed 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 lanreotide. The most commonly (greater than or equal to 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%).
The recommended dose and schedule for 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.Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdf
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
Somatuline Depot is marketed by Basking Ridge, New Jersey based Ipsen Biopharmaceuticals, Inc.
Posted: December 2014
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