FDA Okays New Diagnostic Imaging Agent To Detect Rare Neuroendocrine Tumors

(RTTNews) - The U.S. Food and Drug Administration approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography or PET imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors or NETs.

Netspot is marketed by Advanced Accelerator Applications USA, Inc.

NETs are rare noncancerous (benign) or cancerous (malignant) tumors that develop in the hormone-producing cells of the body's neuroendocrine system. These cells are found throughout the body in organs, such as the stomach, intestines, pancreas, lungs and other locations. NETs have receptors for somatostatin, a hormone that regulates the endocrine system. Ga 68 dotatate, a positron emitting analogue of somatostatin, works by binding to such receptors.

Netspot contributes to overall long-term cumulative radiation exposure, and patients should drink and urinate as often as possible during the first hours following administration to help reduce this risk. No serious adverse reactions have been identified.