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FDA approves Ipsen’s Somatuline Depot Injection to treat GEP-NETs

The US Food and Drug Administration (FDA) has granted approval for Ipsen Biopharmaceuticals's Somatuline Depot (lanreotide) injection 120mg to treat unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

The approval was based on demonstration of improved progression-free survival (PFS) in a 96-week Phase III trial called CLARINET.

The multi-center, international, randomized, double-blind, placebo-controlled trial enrolled a total of 204 patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic, non-functioning GEP-NETs in 48 centers across 14 countries.

During the trial, patients were given either Somatuline (lanreotide) 120mg or placebo subcutaneously every 28 days.

Ipsen chairman and chief executive officer Marc de Garidel said: "This represents a significant step forward in the treatment of this cancer, which affects thousands of Americans. In the US, we have diligently built a robust commercial organization that will execute on the launch of Somatuline in this indication in early 2015."

In the US, somatuline was previously approved for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.

Royal Free Hospital professor of Gastroenterology & Gastrointestinal Neuroendocrinology and principal investigator of CLARINET Martyn Caplin said: "Somatuline has shown substantial clinical benefit in treating both pancreatic and gastrointestinal neuroendocrine tumors and can be considered as a first line therapy in the treatment of those tumors.

"I am looking forward to further regulatory approvals around the world so that patients with pancreatic and gastrointestinal neuroendocrine tumors can have access to this effective and well tolerated therapy."