FDA approves new PET agent for rare neuroendocrine tumors

The U.S. Food and Drug Administration (FDA) has approved the radiopharmaceutical gallium-68 (Ga-68) DOTATATE for use with PET imaging.

The radioactive probe, marketed by Advanced Accelerator Applications (AAA) under the brand name Netspot, is intended to help locate tumors in adult and pediatric patients with the rare condition of somatostatin receptor-positive neuroendocrine tumors (NETs).

NETs develop in the hormone-producing cells of the body's neuroendocrine system; these cells are found in organs such as the stomach, intestines, pancreas, lungs, and other locations.

The uptake of Ga-68 DOTATATE can be seen in these tumors and a variety of other cancers, but may need to be confirmed by histopathology.

Three studies validated the safety and effectiveness of Netspot, which previously received priority review and orphan drug status from the FDA.

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