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Posted 16 Dec 2014 by Drugs.com
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. ... Read more