On June 1, 2016, the FDA approved gallium (Ga)-68 dotatate injection (Netspot; Advanced Accelerator Applications USA), the first diagnostic imaging agent to detect somatostatin receptor–positive neuroendocrine tumors (NETs). Netspot is available as a single-dose injection and is used in conjunction with positron emission tomography imaging to aid in locating these tumors in adults and in pediatric patients.
The FDA previously granted an orphan drug designation and a priority review status to Netspot, before its final approval.
NETs develop in neuroendocrine cells throughout the body, including in the stomach, intestines, pancreas, and lungs. Ga-68 dotatate works by binding to somatostatin receptors; somatostatin is the hormone that regulates the endocrine system.
“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 FDA’s Division of Medical Imaging Products. “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.”
The safety and effectiveness of Netspot were established in 3 clinical studies. In the first study, images using Ga-68 dotatate and an approved drug were compared and then confirmed with computed tomography scans or with magnetic resonance imaging. In the second study, images using Ga-68 dotatate were evaluated by histopathology. The third study evaluated patients with recurrent NET using Ga-68 dotatate images. The findings from all 3 studies confirmed the efficacy of Ga-68 dotatate imaging in locating NETs.
No serious adverse events were identified during the trials; however, the FDA notes that Netspot does add to patients’ overall long-term cumulative radiation exposure. The FDA encourages patients to drink and urinate as much as possible in the first hours after the administration of the diagnostic agent, to reduce the risk.