FDA approvals

FDA approves Somatuline Depot for gastroenteropancreatic neuroendocrine tumors

The FDA today approved lanreotide for treatment of patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

The approval was based in part on results of a trial that included 204 patients with non-functioning gastroenteropancreatic neuroendocrine tumors. More than half of the patients (55%) had tumors that were outside of the pancreas.

Researchers randomly assigned patients to receive 120 mg subcutaneous lanreotide (Somatuline Depot, Ipsen Pharma) or placebo every 28 days.

Median PFS had not been reached at the time of the analysis among patients who received the study drug; however, researchers estimate that it will exceed 22 months. Patients who received placebo demonstrated a median PFS of 16.6 months.

Overall, lanreotide significantly prolonged PFS compared with placebo (HR=0.47; 95% CI, 0.3-0.73).

Safety data were available from 101 patients who received at least one dose of lanreotide. Results showed ≥10% of these patients experienced abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension and cholelithiasis. Vomiting was the most common severe adverse event, and it occurred in 4% of patients.

Lanreotide was previously approved as a long-term treatment option for patients with acromegaly who had an inadequate response to surgery or radiation therapy, or for whom those treatments are not an option.

The FDA today approved lanreotide for treatment of patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

The approval was based in part on results of a trial that included 204 patients with non-functioning gastroenteropancreatic neuroendocrine tumors. More than half of the patients (55%) had tumors that were outside of the pancreas.

Researchers randomly assigned patients to receive 120 mg subcutaneous lanreotide (Somatuline Depot, Ipsen Pharma) or placebo every 28 days.

Median PFS had not been reached at the time of the analysis among patients who received the study drug; however, researchers estimate that it will exceed 22 months. Patients who received placebo demonstrated a median PFS of 16.6 months.

Overall, lanreotide significantly prolonged PFS compared with placebo (HR=0.47; 95% CI, 0.3-0.73).

Safety data were available from 101 patients who received at least one dose of lanreotide. Results showed ≥10% of these patients experienced abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension and cholelithiasis. Vomiting was the most common severe adverse event, and it occurred in 4% of patients.

Lanreotide was previously approved as a long-term treatment option for patients with acromegaly who had an inadequate response to surgery or radiation therapy, or for whom those treatments are not an option.