Lanreotide has been approved for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The Food and Drug Administration announced approval of the drug, marketed as Somatuline Depot by Ipsen Pharma on Dec. 16, following a priority, expedited review granted in September. 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, according to the FDA statement.
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The FDA based approval on results of the phase III CLARINET study, a randomized, double-blind, placebo-controlled trial evaluating lanreotide’s efficacy and safety in 204 patients with well or moderately differentiated, nonfunctioning GEP-NETs. Patients were randomized to receive either lanreotide 120 mg or placebo subcutaneously every 28 days.
Progression-free survival (PFS) was significantly longer in the lanreotide arm (hazard ratio, 0.47; P < .001). The median PFS in the lanreotide arm had not been reached at the time of the final analysis and will exceed 22 months, while the median PFS in the placebo arm was 16.6 months, the FDA reported in the statement.
Commonly reported adverse reactions in lanreotide-treated patients included abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis. The most common serious adverse reaction of lanreotide observed in CLARINET 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, the FDA statement said.
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