Ipsen Biopharmaceuticals cancer treatment approved

BASKING RIDGE, N.J. — Ipsen Biopharmaceuticals on Tuesday announced that Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline) was approved by the U.S. Food and Drug Administration for the treatment of gastroenteropancreatic neuroendocrine tumors in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival.

 

“Somatuline is the first and only treatment with a statistically significant progression-free survival benefit approved by the FDA for patients as an antitumor therapy in the treatment of gastrointestinal and pancreatic neuroendocrine tumors," stated Cynthia Schwalm, president and CEO Ipsen Biopharmaceuticals. 

 

Somatuline will be delivered via a newly approved, ready-to-use, prefilled syringe, which incorporates Safe’n’Sound technology, including a retractable needle guard to help avoid needle sticks, and it is manufactured without latex or natural dry rubber. The new delivery device does not require reconstitution and is a low volume (0.5 mL) deep subcutaneous injection offering a streamlined process that supports full dose delivery.

 

The approval of Somatuline was based on a 96-week landmark registrational Phase III, double-blind, placebo-controlled study (CLARINET) of 204 patients enrolled in 48 centers across 14 countries. The trial showed that Somatuline reduced the risk of disease progression or death by 53% versus placebo in patients with advanced gastrointestinal and pancreatic neuroendocrine tumors. Safety data generated from the Phase III study was consistent with the known safety profile of Somatuline. The rates of discontinuation due to treatment-emergent adverse reactions were 5% in the Somatuline arm and 3% in the placebo arm.

 

Gastrointestinal and pancreatic neuroendocrine tumors are rare but serious cancers. There are an estimated 112,000 individuals currently living with neuroendocrine tumors in the United States, and the incidence and prevalence of this type of cancer have risen 4-to-6 fold in the last 30 years. Furthermore, up to 90% of patients are incorrectly diagnosed, many for more than five years, meaning that they are often diagnosed at a late stage. During this process, patients may be misdiagnosed with other gastrointestinal diseases, such as irritable bowel syndrome or Crohn’s disease.

 

“Somatuline is the first somatostatin analog to demonstrate a statistically significant improvement in progression-free survival, a clinically significant endpoint in oncology, which measures how long the patient continues to live with the disease without it getting any worse,” commented Alexandria Phan, director of GI Medical Oncology at Houston Methodist. “Somatuline offers a new weapon in our fight against this deadly disease.”