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FDA Grants Priority Review to Somatuline for GEP-NETs

doi: 10.1097/01.COT.0000455793.78389.81


The U.S. Food and Drug Administration has granted priority review to Somatuline Depot injection for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Somatuline contains lanreotide acetate, a somatostatin analogue that inhibits the secretion of several endocrine, exocrine, and paracrine amines and peptides. The drug is approved in the U.S. 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 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).

GEP-NETs affect five out of every 100,000 people in the U.S., and incidence has more than quadrupled in the past 30 years, the drug's manufacturer Ispen, noted in a press release.

Somatuline's application is based on data from the randomized, double-blind, Phase III CLARINET study of 206 patients from 48 centers with well or moderately differentiated non-functioning enteropancreatic neuroendocrine tumors and a proliferation index of less than 10 percent. Patients were randomized to receive Somatuline treatment or placebo. The data found that patients receiving the placebo had a median progression-free survival of 18 months and 33 percent had not progressed or died at 96 weeks, while patients receiving Somatuline did not reach the median for progression-free survival and 65.1 percent had not progressed or died at 96 weeks. These findings showed a 53 percent reduction in risk of disease progression or death.

The most common adverse reactions were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reaction (9%), constipation (8%), flatulence (7%), headache (7%), arthralgia (7%), vomiting (7%), and loose stools (6%). Serious side effects could include gallstones, changes in blood sugar, slow heart rate, and high blood pressure.

© 2014 by Lippincott Williams & Wilkins, Inc.
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