FDA Okays Imaging Agent (Netspot ) for Neuroendocrine Tumors

Susan Jeffrey

Disclosures

June 01, 2016

The US Food and Drug Administration (FDA) has approved the first kit for the preparation of gallium Ga 68 dotatate injection (Netspot, Advanced Accelerator Applications USA, Inc), a radioactive diagnostic agent for use in positron emission tomography (PET) imaging.

The agent is for imaging of rare somatostatin receptor-positive neuroendocrine tumors (NETs) in both adult and pediatric patients. NETS can be either benign or malignant tumors that develop in the hormone-producing cells of the neuroendocrine system found throughout the body in organs including the stomach, intestines, pancreas, and lungs, a statement from the FDA notes.

NETs have receptors for the hormone somatostatin, the statement notes. Ga 68 dotatate, a positron-emitting analogue of somatostatin, works by binding to these receptors.

"Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical," said Libero Marzella, MD, PhD, director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research, in the FDA statement. "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."

The product 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 NETs, the statement said. "This uptake can also be seen in a variety of other tumor types or other pathologic conditions, or might occur as a normal variant," the FDA writes. "The uptake of Ga 68 dotatate may need to be confirmed by histopathology or other assessments."

Approval is based on three studies of the product. The first compared GA 68 dotatate images of NETs to those obtained with an approved agent and then confirmed with computed tomography and magnetic resonance imaging. The second looked at the images using histopathology or clinical follow-up as reference standards.

Finally, the third study evaluated patients with NET recurrence using GA 68 dotatate images, the FDA statement said. "The results of all three studies confirmed the usefulness of Ga 68 dotatate images in finding the location of the neuroendocrine tumors.

"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," the agency adds. No serious adverse reactions have been identified, the FDA notes.

The FDA granted Priority Review and orphan drug designations for Netspot. Priority review status is granted to applications for drugs that, if approved, would be a significant improvement in safety or effectiveness in the treatment of a serious condition. Orphan drug designation provides incentives such as tax credits, user fee waivers, and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.

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