FDA approves supplemental indication for Somatuline Depot (lanreotide) in carcinoid syndrome.- Ipsen.
Ipsen announced that the FDA has approved a supplemental indication for Somatuline Depot (lanreotide) Injection 120 mg for the treatment of carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analogue rescue therapy. Somatuline Depot is also approved for the improvement of progression-free survival (PFS) in patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors. 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.
Comment: Somatuline Depot is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.