SPINET Trial Could Alter Practice for Patients With Lung NETs

Excerpt:

“Since its FDA approval in 2014, the somatostatin analog lanreotide (Somatuline Depot) has been creating fresh options for select patients with gastroenteropancreatic neuroendocrine tumors (NETs), given the significant improvement in progression-free survival (PFS) demonstrated in this population.

“Now, investigators are examining the potential that the agent could have in patients with lung NETs—an area that is greatly lacking in research— in a potentially practice-changing clinical trial that seeks to determine the role of the synthetic growth inhibitory hormone in patients with the rare tumor type. Thus far, no prospective trials specifically for patients with lung NETs have been reported, researchers have noted.”

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FDA Grants Priority Review to Lanreotide Injection for Gastroenteropancreatic Neuroendocrine Tumors

Editor’s note: In the U.S., a drug must be approved by the U.S. Food and Drug Administration (FDA) in order for it to be prescribed to patients with specific diseases. Particularly promising drugs might be granted Priority Review, meaning that the FDA agrees to work with the drug manufacturer to accelerate the approval process. The FDA recently granted priority review to a drug meant to treat a subset of pancreatic cancer tumors known as gastroenteropancreatic neuroendocrine tumors. The drug is called lanreotide (aka Somatuline Depot). The FDA’s decision was based on promising results for the lanreotide in a clinical trial that tested it in volunteer patients.

“The U.S. Food and Drug Administration (FDA) has accepted and granted priority review to Ipsen’s supplemental New Drug Application (sNDA) for the somatostatin analog lanreotide (Somatuline Depot) 120 mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors. The FDA designates priority review status to drug candidates that have the potential to offer a significant improvement in treatment compared to currently approved options. A decision is expected in early 2015.

“In the United States, lanreotide is indicated 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 active substance in the drug is lanreotide acetate, a somatostatin analog that inhibits the secretion of several endocrine, exocrine, and paracrine amines and peptides.

“ ‘[Lanreotide] is the first and only somatostatin analog to demonstrate a statistically significant improvement in progression-free survival in patients with gastroenteropancreatic neuroendocrine tumors in a large, multinational clinical trial,’ said Cynthia Schwalm, President and CEO of Ipsen North America.”