The US Food and Drug Administration (FDA) has approved lanreotide (Somatuline, Ipsen Pharma) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (NETs), a rare type of cancer.
The drug, which is a depot injection, is already marketed for the long-term treatment of acromegaly.
The approval is based on the demonstration of improved progression-free survival in the CLARINET trial, a multicenter, international, randomized placebo-controlled study.
The 204-patient trial demonstrated a significant prolongation of progression-free survival, the primary end point, in the lanreotide group (hazard ratio, 0.47; 95% confidence interval [CI], 0.30 - 0.73); P < 0.001; log-rank test).
Median progression-free survival in the lanreotide group had not been reached at the time of the final analysis, but will exceed 22.0 months, according to FDA press materials. In the placebo group, median progression-free survival was 16.6 months.
Lanreotide 120 mg was administered subcutaneously every 28 days.
Results from CLARINET were published earlier this year in the New England Journal of Medicine (2014;371:224-233).
Trial participants 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 CLARINET results could change current practice and establish the somatostatin analogues, a class of drug that includes lanreotide, as first-line treatment, an expert told Medscape Medical News in July.
"CLARINET is a very important trial," said Jonathon Strosberg, MD, chair of the Gastrointestinal Department Research Program at the H. Lee Moffitt Cancer Center in Tampa, Florida. "It basically shows that somatostatin analogues can be used for tumor control in a variety of neuroendocrine tumors, not just midgut NETs."
Dr Strosberg, who was not part of the study, said that other treatments for these tumors are "considerably more toxic" than somatostatin analogues.
In the CLARINET trial, safety data from 101 patients who received at least one dose of lanreotide show that the most common adverse reactions in lanreotide-treated patients were 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%).
The manufacturer notes in a press release that there are an estimated 112,000 individuals currently living with neuroendocrine tumors in the United States, and that the incidence and prevalence of this type of cancer have risen 4- to 6-fold in the past 30 years.
Up to 90% of patients are incorrectly diagnosed, many for more than 5 years, meaning that they are often diagnosed at a late stage, the company notes. During this process, patients can be misdiagnosed with other gastrointestinal diseases, such as irritable bowel syndrome or Crohn's disease.
"Lanreotide is the first somatostatin analog to demonstrate a statistically significant improvement in progression-free survival, a clinically significant end point in oncology which measures how long the patient continues to live with the disease without it getting any worse," Alexandria Phan, MD, director of Gastrointestinal Medical Oncology at the Houston Methodist Cancer Center, said in the press release. The drug "offers a new weapon in our fight against this deadly disease," she added.
Full prescribing information is available on the FDA website.
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Cite this: FDA Approves Lanreotide for Neuroendocrine Tumors - Medscape - Dec 17, 2014.
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