FDA Grants Priority Review to Lanreotide Injection for Gastroenteropancreatic Neuroendocrine Tumors
The U.S. Food and Drug Administration (FDA) has accepted and granted priority review to Ipsen’s supplemental New Drug Application (sNDA) for the somatostatin analog lanreotide (Somatuline Depot) 120 mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors. The FDA designates priority review status to drug candidates that have the potential to offer a significant improvement in treatment compared to currently approved options. A decision is expected in early 2015.
In the United States, lanreotide is indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. The active substance in the drug is lanreotide acetate, a somatostatin analog that inhibits the secretion of several endocrine, exocrine, and paracrine amines and peptides.
“[Lanreotide] is the first and only somatostatin analog to demonstrate a statistically significant improvement in progression-free survival in patients with gastroenteropancreatic neuroendocrine tumors in a large, multinational clinical trial,” said Cynthia Schwalm, President and CEO of Ipsen North America.
CLARINET Trial
The regulatory submission was supported by the results of the investigational phase III CLARINET study, which demonstrated the antitumor effect of lanreotide in the treatment of patients with gastroenteropancreatic neuroendocrine tumors, and which was recently published in The New England Journal of Medicine.
The randomized, double-blind, placebo-controlled, multinational trial enrolled 204 patients from 48 centers across 14 countries with well or moderately differentiated nonfunctioning enteropancreatic neuroendocrine tumors and a proliferation index of < 10%. Patients were randomly assigned to receive an extended-release aqueous gel formulation of lanreotide or placebo. The primary endpoint was time to either disease progression or death.
Patients treated with lanreotide experienced significantly prolonged progression-free survival compared with the placebo group (not reached vs 18.0 months). At 96 weeks, the estimated rates of progression-free survival were 65.1% for the lanreotide group vs 33% for the placebo group, representing a 53% reduction in risk of disease progression or death (hazard ratio = 0.47, 95% confidence interval = 0.30–0.73).
The most common adverse reactions (incidence > 5%) were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), and injection-site reaction (9%), constipation (8%), flatulence (7%), headache (7%), arthralgia (7%), vomiting (7%), and loose stools (6%).
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