FDA approves Netspot to detect rare neuroendocrine tumors

The FDA approved the diagnostic imaging agent Netspot to detect rare neuroendocrine tumors.

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 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.

The studies reported no serious adverse reactions.

“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.”