FDA approves Ipsen's Somatuline for metastatic gastroentero pancreatic neuroendocrine tumors

The US Food and Drug Administration has approved Somatuline Depot (lanreotide) injection 120mg, manufactured by French drugmaker Ipsen (Euronext: IPN) for adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

This is the first therapy approved by the FDA for this indication, and the company is preparing for a US launch in the first quarter of 2015. The drug - which generated sales of around $170 million in the first half of this year - was granted priority review, but an FDA decision had not been expected until the first quarter of 2015, so the earlier approval is a pleasant surprise for the company.

Marc de Garidel, chairman and chief executive of Ipsen, said: “I am pleased with the approval by the FDA of this new indication for Somatuline, which is a testimony to the scientific quality of those clinical results. Ipsen is now prepared to launch in the USA the first antitumor therapeutic approved for the treatment of both pancreatic and gastrointestinal neuroendocrine tumors. This represents a significant step forward in the treatment of this cancer, which affects thousands of Americans. In the USA, we have diligently built a robust commercial organization that will execute on the launch of Somatuline in this indication in early 2015.”