• Center on Health Equity and Access
  • Clinical
  • Health Care Cost
  • Health Care Delivery
  • Insurance
  • Policy
  • Technology
  • Value-Based Care

Lanreotide Approved for Gastroenteropancreatic Neuroendocrine Tumors

Article

The approval was based on the results of a clinical trial that demonstrated improved PFS in patients on lanreotide. While the median PFS in the placebo arm was 16 months, patients in the lanreotide arm had not yet reached median PFS at the time of analysis, and it was anticipated to extend beyond 22 months.

On December 16, 2014, the U. S. Food and Drug Administration approved lanreotide (Somatuline Depot Injection, Ipsen Pharma) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. Lanreotide was previously approved for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.

The approval was based on demonstration of improved progression-free survival (PFS) in a multi-center, international, randomized (1:1), double-blind, placebo-controlled study (Trial 2- 55-52030-726) that enrolled 204 patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic, non-functioning GEP-NETs. Fifty-five percent of patients (113/204) had neuroendocrine tumors arising outside the pancreas. Patients were randomized to receive either lanreotide 120 mg or placebo subcutaneously every 28 days.

News of the approval on the FDA website: http://1.usa.gov/1znFbkv

Related Videos
Will Shapiro
Mila Felder, MD, FACEP
Kiana Mehring, MBA, director of strategic partnerships, managed care at Florida Cancer Specialists & Research Institute (FCS)
Miriam J. Atkins, MD, FACP, president of the Community Oncology Alliance (COA) and physician and partner of AO Multispecialty Clinic in Augusta, Georgia.
Dr Lucy Langer
Edward Arrowsmith, MD, MPH
Dr Kathi Mooney
Tiago Biachi de Castria, MD, PhD, Moffitt Cancer Center
Related Content
© 2024 MJH Life Sciences
AJMC®
All rights reserved.