Netspot Diagnostic Imaging Agent to Detect Rare Neuroendocrine Tumors Approved by the FDA

Advanced diagnostic tool expected to be of critical value, especially since neuroendocrine tumors are on the rise in adolescents.

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.
Man in an MRI scanner“Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical,” said Libero Marzella, MD, PhD, Director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, in a statement to the press. “Netspot provides another diagnostic tool whose results will help clinicians determine the location and extent of the tumor. This information is important for planning the appropriate course of therapy.”

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.”

  • Netspot was granted orphan drug designation by the FDA in 2014, and received approval following a Priority Review (June 1, 2016).

“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

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