Somatuline Depot sNDA Submitted for GEP-NETs

Ipsen Biopharmaceuticals announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for Somatuline Depot (lanreotide acetate) 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Somatuline Depot, a somatostatin analogue, inhibits the secretion of several endocrine, exocrine, and paracrine functions.

The NDA submission was supported by results from the CLARINET Phase 3 study which demonstrated the antiproliferative effect of Somatuline in the treatment of patients with GEP-NETs. Data from CLARINET showed that investigational treatment with Somatuline substantially prolonged time to disease progression or death vs. placebo (hazard ratio 0.47, P=0.0002). Safety data generated from the CLARINET study were consistent with the known safety profile of Somatuline.

RELATED: Endocrine Disorders Resource Center

Somatuline Depot is already approved for the long-treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.

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