The Food and Drug Administration (FDA) has approved Netspot (Advanced Accelerator Applications), a radioactive diagnostic agent for positron emission topography (PET) imaging. The probe will aid in locating tumors in patients with somatostatin receptor positive neuroendocrine tumors (NETs), a rare set of tumors which may or may not be cancerous.
Netspot will be supplied in two forms; as a Netspot injection and a single-dose kit form for preparation of gallium Ga 68 dotatate injection, as such, it is the first kit of its kind. The mechanism of Netspot measures the uptake of Ga 68 dotatate reflecting the level of somatostatin receptor density in neuroendocrine tumors which can be confirmed by histopathology.
The safety and efficacy of Netspot was demonstrated in three separate clinical studies, showing the competency of Ga 68 dotatate images in locating NETs; when compared to images obtained with approved drugs, when evaluating images using histopathology, and when evaluating patients with NET recurrence. No serious adverse reactions were seen during trials, however Netspot does contribute 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.
“Netspot provides another diagnostic tool whose results will help clinicians determine the location and extent of the tumor,” said Libero Marzella, MD, PhD, and the FDAs director of the Division of Medical Imaging Products.
Netspot was previously granted Priority Review and orphan drug designation by the FDA. Advanced Accelerator Applications plans to make Netspot available from local radiopharmacies in selected metropolitan areas.
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