The U.S. Food and Drug Administration has granted approval for Somatuline (lanreotide; Ipsen) injection 120 mg to improve progression-free survival in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.
The approval comes after the results of the CLARINET study revealed that Somatuline caused a 53% reduction in disease progression or death risk when compared with placebo in patients with advanced pancreatic and gastrointestinal neuroendocrine tumors (P<0.001).
CLARINET was a phase 3, double-blind, placebo controlled study that included 204 patients from 48 centers in 14 countries. The study also revealed that the treatment was tolerable, with safety profile that was consistent with what is known for Somatuline. Five percent patients enrolled in the Somatuline treatment arm discontinued treatment because of adverse events compared with 3% of patients in the placebo arm.
The approval of Somatuline also marks the first antitumor therapy with statistically significant increase in progression-free survival for this group of patients.
Gastroenteropancreatic neuroendocrine tumors are a rare, but serious, form of cancer with a diagnosis estimated in 5 out of 100,000 people in the United States. The incidence of this disease, however, has increased between 4- to 6-fold within the last 30 years. As many as 90% of patients with gastroenteropancreatic neuroendocrine tumors are initially misdiagnosed, leading to many patients receiving their diagnosis with late-stage disease.
“Lanreotide 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 Gastrointestinal Medical Oncology at Houston Methodist Cancer Center, said in a press release.