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BRIEF-Ipsen's Somatuline Depot gets FDA approval for gastroenteropancreatic neuroendocrine tumors
December 17, 2014 / 7:02 AM / 3 years ago

BRIEF-Ipsen's Somatuline Depot gets FDA approval for gastroenteropancreatic neuroendocrine tumors

Dec 17 (Reuters) - Ipsen SA :

* Said on Tuesday that Somatuline Depot (lanreotide) Injection 120 mg was approved by the FDA for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

* Somatuline was previously approved in the United States 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

* Somatuline's approval was based on demonstration of improved progression-free survival (PFS) in CLARINET multi-center, international, randomized (1:1), double-blind, placebo-controlled study

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