FDA approves diagnostic kit for rare tumor detection

With headquarter in France, Advanced Accelerator Applications S.A. (“AAA” or “the Company”) announced that the US Food and Drug Administration (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 US. NETSPOT 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 the approval, NETSPOT will be made available to the US market as soon as possible. AAA intends to commercialize the product in the US 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 adiopharmacy in selected metropolitan areas.

NETSPOT is currently approved for use with the GalliaPharm Ga 68 generator from Eckert & Ziegler.

“The FDA approval of NETSPOT is a key milestone in our mission of improving the lives of NET patients,” said Stefano Buono, Chief Executive Officer of AAA. “NETSPOT has the potential to significantly improve the accuracy of NET diagnosis, while reducing radiation exposure for patients. We believe that the use of NETSPOT should also offer increased comfort for patients by potentially shortening a procedure that is currently performed over 24 hours or more to just a few hours.”

The estimated incidence of NETs for the combined populations of the United States and the European Union is approximately 47,300 patients/year.1 Even though NETs have historically been considered as rare tumors (orphan disease) their incidence has grown over 500% over the last 3 decades.

A press release can be found from Advanced Accelerator Applications website by clicking here.