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FDA Gives Nod to Somatuline Depot (Lanreotide) for Treatment of Neuroendocrine Tumors

Approval expands indication for acromegaly drug

The FDA has given the green light to Somatuline Depot (lanreotide, Ipsen) injection for the treatment of adults with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Somatuline was previously approved in the U.S. for the long-term treatment of acromegalic patients who had shown an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy was not an option.

The new approval was based on the demonstration of improved progression-free survival (PFS) in the international, randomized, double-blind, placebo-controlled CLARINET trial, which enrolled 204 patients with unresectable, well- or moderately differentiated, locally advanced or metastatic, non-functioning GEP-NETs. The patients were randomly assigned to receive either lanreotide 120 mg or placebo, administered via subcutaneous injection every 28 days. The study’s primary efficacy endpoint was PFS, as determined by an independent central radiology review.

The study demonstrated a significant prolongation of PFS in the lanreotide arm compared with the placebo arm (hazard ratio, 0.47; P < 0.001). The median PFS in the lanreotide arm had not been reached at the time of the final analysis and therefore is greater than 22 months. The median PFS in the placebo arm was 16.6 months.

Safety data were evaluated in 101 patients who received at least one dose of lanreotide. The most commonly reported adverse reactions in lanreotide-treated patients included abdominal pain, musculoskeletal pain, vomiting, headache, injection-site reactions, hyperglycemia, hypertension, and cholelithiasis. Vomiting was the most common serious adverse reaction associated with lanreotide, affecting 4% of patients.

The recommended dosage of lanreotide for patients with GEP-NETs is 120 mg administered by deep subcutaneous injection every 28 days. Treatment should continue until disease progression or unacceptable toxicity occurs.

Pancreatic and gastrointestinal neuroendocrine tumors are rare cancers. An estimated 112,000 individuals currently have GEP-NETs in the U.S. The incidence and prevalence of this type of cancer have increased four-to six-fold during the last 30 years. Moreover, up to 90% of patients are diagnosed at a late stage.

Lanreotide acetate is a somatostatin analogue that inhibits the secretion of several endocrine, exocrine, and paracrine functions. It has been shown to be effective at inhibiting the secretion of growth hormone and of certain hormones in the digestive system. Lanreotide is marketed as Somatuline Depot in the U.S. and as Somatuline Autogel in other countries, where it has marketing authorization for the treatment of acromegaly or for the symptomatic treatment of neuroendocrine tumors.

Source: Ipsen; December 16, 2014.

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