December 16, 2014: The US Food and Drug Administration (FDA) today 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.”
Earlier this year the FDA had granted priority review to Ipsen’s supplemental New Drug Application (sNDA) for the somatostatin analog lanreotide (Somatuline Depot) 120 mg injection for GEP-NETs. FDA priority review status enables drug candidates that “have the potential to offer a significant improvement in treatment compared to currently approved options.”
The submission to the FDA was supported by results of the CLARINET (Placebo-Controlled Study of Lanreotide Antiprolierative Response in Patients with GEP-NET) Phase III trial which demonstrated that lanreotide significantly prolonged progression-free survival in patients with nonfunctioning gastroenteropancreatic (GEP) neuroendocrine tumors (NETS) compared to treatment with placebo. The CLARINET study builds upon the earlier PROMID prospective trial. A much larger, multicenter, randomized, double-blind trial, CLARINET involved 204 patients, with a mean age of 63 in the lanreotide arm and 62 in the placebo arm. Dr. Kjell Oberg (pictured), NET cancer specialist from University Hospital Uppsala in Sweden, reported the results at the European Cancer Congress 2013.
The results of the CLARINET study were published in the July 17, 2014 issue of the New England Journal of Medicine.