Ipsen Biopharmaceuticals, Inc., announced today that Somatuline® Depot® (lanreotide) Injection has been approved by the Food and Drug Administration (FDA) for the treatment of inoperable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which include pancreatic neuroendocrine tumors (PNETs). This approval comes after Ipsen’s international phase III CLARINET trial met its primary endpoint of significantly improving progression-free survival (PFS). The median PFS in the Somatuline® (lanreotide) arm had not been reached at the time of the final analysis and therefore is greater than 22 months. The median PFS in the placebo arm was 16.6 months. The approval of this therapy represents encouraging treatment progress for patients with pancreatic neuroendocrine tumors.
Somatuline® is not approved, nor proven to be effective, in the treatment of the most common form of pancreatic cancer, adenocarcinoma. Those with pancreatic neuroendocrine tumors (PNETs) should contact their oncologists to discuss whether this is a suitable treatment option.
If you have any questions about the results of this clinical trial or Somatuline®, our Patient and Liaison Services (PALS) program can provide you with additional information. Contact one of our trained PALS Associates at 877-272-6226, Monday through Friday, from 7 a.m. to 5 p.m., Pacific Time, or email firstname.lastname@example.org to learn more.
The Pancreatic Cancer Action Network recommends that all patients consider clinical trials when exploring treatment options. For more information about ongoing clinical trials or any other questions about pancreatic cancer treatment or diagnosis, please contact a PALS Associate.