Patients with a rare type of cancer called gastroenteropancreatic neuroendocrine tumours (GEP-NETs) have gained access to a new treatment option following US approval of Ipsen’s Somatuline Depot (lanreotide) injection.
The US Food and Drug Administration has cleared the drug’s use to improve progression-free survival in adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic disease.
Approval came on the back of data from the CLARINET clinical study, which showed Somatuline cut the risk of disease progression or death by 53% versus placebo, according to the firm.
Gastrointestinal and pancreatic neuroendocrine tumours are diagnosed in around five out of every 100,000 people in the US and so are classed as rare, but their incidence and prevalence are increasing, having risen four-to-six fold in the last 30 years.
Somatuline is the first and only treatment with a statistically significant progression-free survival benefit approved by the FDA as an antitumor therapy in the treatment of this cancer, said Cynthia Schwalm, president and chief executive of Ipsen Biopharmaceuticals, noting that the drug has the “potential to help many of the thousands of patients in the US suffering from this devastating disease”.