FDA Approves Antitumor Therapy

Lanreotide is first antitumor drug to show statistically significant progression-free survival in patients with gastrointestinal and pancreatic tumors.

The FDA this week granted approval for a new therapy that showed promising results in treating a combined population of patients with gastrointestinal and pancreatic tumors.

Lanreotide (Somatuline) was approved for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease, in order to improve progression-free survival (PFS).

“The approval of Somatuline for the treatment of patients living with gastrointestinal and pancreatic tumors is a major achievement for Ipsen that will provide a new therapeutic option with the potential to help many of the thousands of patients in the United States suffering from this devastating disease,” Cynthia Schwalm, president and CEO of Ipsen Biopharmaceuticals, Inc, said in a press release. “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. This is a significant step forward in our mission to develop and deliver innovative therapies to treat serious illnesses.”

Lanreotide was approved following a 96-week phase 3 double-blind, placebo-controlled study that enrolled 204 patients in 48 centers across 14 countries. Lanreotide was found to reduce the risk of disease progression or death by 53% in patients with advanced gastrointestinal and pancreatic neuroendocrine tumors compared with placebo.

Treatment-related adverse events led to a discontinuation rate of 5% (5 of 101 patients) in the lanreotide cohort and 3% (3 of 103 patients) in the placebo cohort.

Patients in the placebo group had a median PFS of 16.6 months and 33% had not progressed or died at 96 weeks. In the lanreotide group, median PFS was not reached and will be greater than 22 months, while 65.1% had not progressed or died at 96 weeks.

The results represent a 53% reduction in risk of disease progression or death with lanreotide compared with placebo. The overall survival and quality of life measures showed no differences between both groups.

“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,” Alexandria Phan, MD, director of GI Medical Oncology at Houston Methodist said in a press release. “Somatuline offers a new weapon in our fight against this deadly disease.”