FDA approves gastroenteropancreatic neuroendocrine tumor drug

The U. S. Food and Drug Administration approved lanreotide (Somatuline Depot Injection, Ipsen Pharma) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

The drug is designed to improve progression-free survival. The approval was based on demonstration of improved progression-free survival in a multicenter, international, randomized, double-blind, placebo-controlled study.

Safety data was also evaluated. The most commonly reported adverse reactions in lanreotide-treated patients were abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, among others.

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