Ipsen announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to its supplemental New Drug Application (sNDA) for Somatuline Depot (lanreotide acetate) 120mg injection for the treatment of gastoenteropancreatic neuroendocrine tumors (GEP-NETs). Somatuline Depot is a somatostatin analogue that inhibits the secretion of several endocrine, exocrine, and paracrine amines and peptides.
The sNDA submission was based on results from Ipsen’s Phase 3 CLARINET trial which evaluated the anti-proliferative effect of lanreotide in patients with advanced, well-differentiated or moderately differentiated, nonfunctioning, somatostatin receptor–positive neuroendocrine tumors of grade 1 or 2, and documented disease-progression status. The primary endpoint was progression-free survival, defined as the time to disease progression or death. Lanreotide, as compared with placebo, was associated with significantly prolonged progression-free survival (median not reached vs. median of 18.0 months, P<0.001 by the stratified log-rank test; hazard ratio for progression or death, 0.47; 95% CI, 0.30–0.73). The estimated rates of progression-free survival at 24 months were 65.1% (95% CI, 54.0–74.1) in the lanreotide group and 33.0% (95% CI, 23.0–43.3) in the placebo group.
Somatuline Depot is already approved for the long-term treatment of acromegaly in patients who have had an inadequate response or cannot be treated with surgery and/or radiotherapy.
For more information call (866) 837-2422 or visit Ipsen.com.