The Food and Drug Administration has approved Somatuline Depot (Ianreotide) Injection for the treatment of adult patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which are unresectable, well- or moderately differentiated, locally advanced, or metastatic. The drug is being approved after being granted priority review earlier this year (OT 10/10/14 issue).
The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA).
Somatuline-which contains lanreotide acetate, a somatostatin analogue that inhibits the secretion of several endocrine, exocrine, and paracrine amines and peptides-will be delivered via a newly approved, ready-to-use, prefilled syringe that includes a retractable needle guard to help avoid needle sticks, and it is manufactured without latex or natural dry rubber, according to a news release from the manufacturer, Ispen Biopharmaceuticals, Inc. The new delivery device does not require reconstitution and is a low volume (0.5 mL) deep subcutaneous injection offering a streamlined process that supports full dose delivery.
The approval is based on data from a Phase III, double-blind study of 204 patients with advanced gastrointestinal and pancreatic neuroendocrine tumors who received treatment with Somatuline or placebo. Median progression-free survival for the patients receiving Somatuline was not reached (and will be greater than 22 months), and 65.1 percent of those patients had no disease progression and had not died at 96 weeks; whereas median progression-free survival for patients treated with the placebo was 16.6 months, and at 96 weeks 33 percent of those patients had no disease progression and had not died.
The most common adverse events reported in the trial for Somatuline were abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis. Five percent of patients receiving Somatuline discontinued treatment due to an adverse event, compared with three percent of patients who received the placebo.