FDA Approves Lanreotide for Neuroendocrine Tumors

The FDA approved lanreotide, manufactured by Ipsen Pharma, for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (NETs).

The drug, which is a depot injection, is already marketed for the long-term treatment of acromegaly.

The drug’s approval was based on the demonstration of improved progression-free survival in the multicenter, international, randomized placebo-controlled CLARINET trial.

The trial included 204 patients who were recruited from 48 care centers in Europe, India, and the United States from June 2006 to April 2013. Patients had NETs that originated in the pancreas, midgut, or hindgut, or were of unknown origin. Of the 113 patients, 55% had NETs arising outside the pancreas. The tumors were unresectable, well or moderately differentiated, and locally advanced or metastatic.

The study demonstrated a significant prolongation of progression-free survival in the lanreotide group (hazard ratio, 0.47; 95% confidence interval [CI], 0.30-0.73); P<.001). Lanreotide 120 mg was administered subcutaneously every 28 days. Median progression-free survival in the lanreotide group had not been reached at the time of the final analysis but will exceed 22 months, according to press materials from the FDA. In the placebo group, median progression-free survival was 16.6 months.

The most common adverse reactions associated with lanreotide-treated patients included abdominal pain, musculoskeletal pain, vomiting, headache, injection-site reaction, hyperglycemia, hypertension, and cholelithiasis. The most common serious adverse reaction in the lanreotide group was vomiting (4%).

An estimated 112,000 individuals are currently living with neuroendocrine tumors in the United States, and the incidence and prevalence of this type of cancer have risen 4- to 6-fold in the past 30 years, according to the drug’s manufacturer.

Up to 90% of patients are incorrectly diagnosed, many for more than 5 years, so they are often diagnosed at a late stage. During this process, patients can be misdiagnosed with other gastrointestinal diseases, such as irritable bowel syndrome or Crohn's disease.—Kerri Fitzgerald