The U.S. Food and Drug Administration has approved Netspot (Somakit-TATE), a radioactive probe designed for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients during positron emission tomography imaging. Netspot, from Advanced Accelerator Applications, is the first kit for the preparation of gallium Ga 68 dotatate injection, the uptake of which reflects the level of somatostatin receptor density in NETs.
Approval Based on Three Clinical Trials
Approval was based on three clinical studies. The first study compared Ga 68 dotatate images of NETs to images obtained with an approved drug, and then confirmed with computed tomography (CT) and/or magnetic resonance imaging (MRI). The second study evaluated Ga 68 dotatate images using histopathology or clinical follow-up as reference standards. The third study evaluated patients with NET recurrence using Ga 68 dotatate images.
Somatostatin Receptor Positive Neuroendocrine Tumors Are on the Rise
“Although NETs are relatively rare, they tend to affect younger patients, and the incidence of NETs is on the rise in the United States,” said Hossein Jadvar, MD, PhD, President of the Society of Nuclear Medicine and Molecular Imaging. “We are pleased to see that the FDA has approved an agent that can facilitate more accurate imaging evaluation of NETs, which may allow more appropriate patient management.”
“We applaud the FDA for recognizing the importance of this advanced imaging agent and granting priority review status,” Dr. Jadvar said.
Advanced Accelerator Applications intends to launch two formulations of the product in the United States: 1) as a kit for reconstitution using a Ga 68 generator, and 2) as a ready-to-use injection delivered from local radiopharmacies in selected metropolitan areas.
June 8, 2016
FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors [news release]. U.S. Food and Drug Administration; June 1, 2016.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504524.htm. Accessed June 6, 2016.
FDA approves new imaging agent for neuroendocrine tumor diagnosis. Society of Nuclear Medicine and Molecular Imaging; June 2, 2016. http://www.snmmi.org/newspublications/NewsDetail.aspx?ItemNumber=15955. Accessed June 6, 2016.
Advanced Accelerator Applications announces FDA approval of NETSPOT (Somakit-TATE), a kit for the preparation of Gallium Ga 68 dotatate for neuroendocrine tumor detection. Advanced Accelerator Applications; June 2, 2016. http://www.adacap.com/wp-content/uploads/2016/06/2016-06-02-PR-AAA-FDA-approves-NETspot-for-diagnosis-of-NETs-FINAL-ENG.pdf Accessed June 6, 2016.