The U.S. Food and Drug Administration has approved a kit used to prepare and inject a PET imaging agent that can ferret out rare somatostatin receptor-positive neuroendocrine tumors (NETs) in adult and pediatric patients.
Marketed by Advanced Accelerator Applications, the kit, to be called Netspot, represents the first clinical application of the radioactive probe drug Ga 68 dotatate, according to FDA.
The agency explains that NETs are rare benign or malignant tumors that develop in the hormone-producing cells of the neuroendocrine system. These tumors have receptors for somatostatin, a hormone that regulates the endocrine system, and Ga 68 dotatate works by binding to such receptors.
“Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical,” FDA director of medical imaging products Libero Marzella, MD, PhD, says in prepared remarks. “Netspot provides another diagnostic tool whose results will help clinicians determine the location and extent of the tumor.”
Advanced Accelerator Applications, headquartered in France, says the product will be made available to the U.S. market as soon as possible.
The company says it intends to sell the product in the U.S. in two forms—as a kit for reconstitution using a Ga 68 generator and as Netspot Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas.