1 June 2016 - The U.S. FDA today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography imaging.

This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).

NETs are rare noncancerous (benign) or cancerous (malignant) tumors that develop in the hormone-producing cells of the body’s neuroendocrine system. These cells are found throughout the body in organs, such as the stomach, intestines, pancreas, lungs and other locations. NETs have receptors for somatostatin, a hormone that regulates the endocrine system. Ga 68 dotatate, a positron emitting analogue of somatostatin, works by binding to such receptors.

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.

Netspot is marketed by Advanced Accelerator Applications USA, Inc.

For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504524.htm