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FDA approves imaging agent to detect neuroendocrine tumors
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The FDA approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for PET scan imaging, according to an agency press release.
This radioactive probe will help locate tumors in adult and pediatric patients with somatostatin receptor positive neuroendocrine tumors. Ga 68 dotatate, a positron emitting analogue of somatostatin, works by binding to the hormone. The FDA granted priority review and orphan drug designations for Netspot (Somakit-TATE, Advanced Accelerator Applications USA, Inc.).
"Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical," Libero Marzella, MD, PhD, director of the division of medical imaging products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Netspot provides another diagnostic tool whose results will help clinicians determine the location and extent of the tumor. This information is important for planning the appropriate course of therapy.”
Netspot is supplied as a sterile, single-dose kit for preparation of Ga 68 dotatate injection for intravenous use. The uptake of Ga 68 dotatate reflects the level of somatostatin-receptor density in neuroendocrine tumors and may need to be confirmed by histopathology or other assessments.
Three studies established the safety and effectiveness of Netspot. The first compared Ga 68 dotatate images of neuroendocrine tumors to images obtained with an approved drug, and then confirmed with CT or MRI imaging. The second evaluated Ga 68 dotatate images using histopathology or clinical follow up as reference standards. The third evaluated patients with neuroendocrine tumor recurrence using Ga 68 dotatate images.
The FDA noted that 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 reported.
"The FDA approval of Netspot is a key milestone in our mission of improving the lives of [neuroendocrine tumor] patients," Stefano Buono, chief executive officer of Advanced Accelerator Applications, said in a company press release. "Netspot has the potential to significantly improve the accuracy of [neuroendocrine tumor] diagnosis, while reducing radiation exposure for patients. We believe that the use of Netspot should also offer increased comfort for patients by potentially shortening a procedure that is currently performed over 24 hours or more to just a few hours."