Somatuline Depot Gains New Antitumor Indication
The Food and Drug Administration (FDA) has approved Somatuline Depot (lanreotide; Ipsen Biopharmaceuticals) injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival.
The FDA's approval was supported by the Phase 3 CLARINET study, a 96-week double-blind, placebo-controlled study of 204 patients across 14 countries. Study data showed that treatment with Somatuline reduced the risk of disease progression or death by 53% vs. placebo in patients with advanced GEP-NETs (P<0.001). Somatuline Depot Injection is the first somatostatin analog to demonstrate statistically significant progression-free survival benefit in the treatment of GEP-NETs.
The Company announced that the Somatuline will be delivered through the newly approved, prefilled syringe that utilizes Safe'n'Sound technology. It features a retractable needle guard and is latex- and natural dry rubber-free. The new prefilled syringe does not require reconstitution and is supplied as a low-volume (0.5mL) deep subcutaneous injection.
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.
Somatuline Depot is available as 60mg/0.2mL, 90mg/0.3mL, and 120mg/0.5mL strengths in single prefilled syringes.
For more information call (866) 837-2422 or visit Ipsen.com.