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Somatuline Depot Approved to Treat Carcinoid Syndrome
Lanreotide injection (Somatuline Depot, Ipsen Biopharmaceuticals, Inc.) 120 mg has received FDA approval for a new indication: the treatment of carcinoid syndrome. When used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
The medication, a somatostatin analog, is also approved for the improvement of progression-free survival in patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The additional approval for carcinoid syndrome was based on “Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment (ELECT): A Randomized, Double-Blind, Placebo-Controlled Trial,” published in Endocrine Practice.
In this 16-week, randomized, double-blind, phase 3 trial, patients with and without prior somatostatin analog use were randomized to lanreotide depot/autogel 120 mg or placebo every four weeks, with access to short-acting octreotide as rescue medication. The primary endpoint was the percentage of days in which short-acting octreotide was used, which was assessed by an analysis of daily diaries.
A total of 115 patients were enrolled (lanreotide, n = 59; placebo, n = 56). The adjusted mean percentage of days with rescue octreotide use was significantly lower in the lanreotide group (33.7%; 95% confidence interval [CI], 25.0%–42.4%) versus the placebo group (48.5%; 95% CI, 39.6%–57.4%). The odds ratio (OR) of full/partial treatment success (three days or less of short-acting octreotide use in weeks 12 to 15) was significantly greater with lanreotide than placebo (OR, 2.4; 95% CI, 1.1–5.3; P = .036).