“Netspot provides another diagnostic tool whose results will help clinicians determine the location and extent of the tumor. “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. AAAs first theragnostic pairing for neuroendocrine tumors includes diagnostic drugs NETSPOT in the US and SomaKit TOC in Europe and therapeutic Lutathera (. The studies reported no serious adverse reactions. Advanced Accelerator Applications USA, Inc, Advanced Accelerator Applications (Italy) S.r.l. The drug identification number (DIN) is 02490005. Netspot is a drug product by ADVANCED ACCELERATOR APPLICATIONS USA, INC., authorized by Health Canada.
The FDA based its approval on positive safety and efficacy results from three studies - the first compared Ga 68 dotatate images of neuroendocrine tumors to images obtained with an approved drug, which were then confirmed with CT or MRI the second study evaluated Ga 68 dotatate images using histopathology or clinical follow-up and the third study evaluated patients with neuroendocrine tumor recurrence using Ga 68 dotatate images. Netspot is a drug product manufactured by ADVANCED ACCELERATOR APPLICATIONS USA, INC., according to the data provided by Health Canada. Netspot (Advanced Accelerator Applications USA) - a sterile, single-dose kit for the preparation of gallium Ga 68 dotatate intravenous injection, a radioactive diagnostic agent for PET imaging - is indicated to help locate tumors in adult and pediatric patients with somatostatin receptor positive neuroendocrine tumors. The FDA approved the diagnostic imaging agent Netspot to detect rare neuroendocrine tumors.
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