The FDA has approved a radioactive probe to assist in the location of somatostatin receptor positive neuroendocrine tumors (NETs).
The probe, called Netspot, is supplied as a sterile, single-dose kit for preparation of Ga 68 dotatate injection for intravenous use. The uptake of Ga 68 dotatate reflects the level of somatostatin receptor density in NETs.
Neuroendocrine tumors (NETs) are a rare type of cancer that originate in neuroendocrine cells throughout the body, and are most often found in the gastrointestinal tract, lungs or pancreas.
NETs often have somatostatin receptors on them. Ga 68 dotatate is a positron emitting analogue of somatostatin that binds to somatostatin receptors.
In a news release
, Libero Marzella, MD, PhD, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research said, "Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical." Dr. Marzella added, “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.”
Efficacy and Safety
The approval of Netspot was based on 3 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. The results of all 3studies confirmed the usefulness of Ga 68 dotatate images in finding the location of the neuroendocrine tumors.
The FDA granted Priority Review and orphan drug designations for Netspot.
Netspot is marketed by Advanced Accelerator Applications USA