The FDA has approved Netspot (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Netspot received approval following a Priority Review from the FDA.
Netspot is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the U.S. It is the first approved drug using Ga 68 as a positron emitter. Gallium Ga 68 dotatate received Orphan Drug Designation from both the FDA and European Medicines Agency (EMA) in March 2014.
Following approval, Netspot will be made available to the U.S. market as soon as possible. The product will be available in the U.S. in two forms: as a kit for reconstitution using a Ga 68 generator, and as Netspot Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas.
The estimated incidence of NETs for the combined populations of the U.S. and the European Union is approximately 47,300 patients/year. Even though NETs have historically been considered as rare tumors (orphan disease), their incidence has grown more than 500 percent over the last 3 decades.