FDA approves first gallium 68Ga-Dotatate radiopharmaceutical tracer for PET imaging of neuroendocrine tumors
The U.S. Food and Drug Administration (FDA) approved the use of gallium 68Ga-Dotatate , a radioactive diagnostic agent for positron emission tomography (PET) imaging to locate somostatin receptor positive neuroendocrine tumors in adult and pediatric patients. The commercial product, a single dose kit for the preparation of a 68Ga-Dotatate injection manufactured by Advanced Accelerator Applications of Saint Genis-Pouilly, France, has been given the market name NETSPOT™.
Neuroendocrine tumors are malignant and benign tumors that affect an estimated 47,300 individuals in Europe and the United States each year. The tumors develop in the hormone-producing cells of the body’s neuroendocrine system, and are located in organs such as the stomach, intestines, pancreas, and lungs.
Neuroendocrine tumors have receptors for somatostatin, a hormone that regulates the endocrine system. 68Ga-Dotatate , a positron emitting analogue of somatostatin, works by binding to such receptors. The uptake of 68Ga-Dotatate reflects the level of somatostatin receptor density in neuroendocrine tumors.
Gallium 68Ga-Dotatate received Orphan Drug Designation in March 2014 from both the FDA and the European Medicines Agency. An orphan drug is defined as a drug that treat diseases or conditions that affect 200,000 or fewer individuals in the United States or 5 out of 100,000 in the European Union.
Advanced Accelerator Applications has announced that NETSPOT will be supplied in the United States by Cardinal Health of Dublin, OH, a healthcare services company operating the largest radiopharmaceutical network in the nation. It is currently approved for use with the GalliaPharm® Ga 68 generator from Eckert & Ziegler.
In its press release, the FDA referenced the three studies that established the safety and effectiveness of NETSPOT, all headed by researchers at Vanderbilt University Medical Center in Nashville, TN. The first compared 68Ga-Dotatate images of neuroendocrine tumors to images obtained with an approved drug, and then confirmed with CT or MRI. The second evaluated 68Ga-Dotatate images using histopathology. The third demonstrated the safety and efficacy of the tracer for the diagnosis, staging, and treatment management of neuroendocrine tumors. Results of the third study were published in the May 2016 issue of the Journal of Nuclear Medicine, and are the subject of an article published in the Applied Radiology Newsletter and posted online here.