FDA approves Netspot (gallium 68 dotatate diagnostic) for PET imaging of somatostatin receptor positive neuroendocrine tumors- Advanced Accelerator Applications
The FDA has approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging, from Advanced Accelerator Applications. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).
Three studies established the safety and effectiveness of Netspot. The first 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 evaluated Ga 68 dotatate images using histopathology (the study of tissue changes caused by disease), or clinical follow up as reference standards; and the third evaluated patients with NET recurrence using Ga 68 dotatate images. The results of all three studies confirmed the usefulness of Ga 68 dotatate images in finding the location of the neuroendocrine tumors.
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