Advanced Accelerator Applications Announces Positive EMA Opinion on Application for SomaKit TOC


AAA today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Marketing Authorization Application for SomaKit TOC 40 µg, a kit for radiopharmaceutical preparation of gallium (Ga 68) edotreotide solution for injection, for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NET) for localizing primary tumors and their metastases.

The European Commission (EC) decision regarding granting of marketing authorization in all EU countries is expected in the coming months. Once marketing authorization is granted, SomaKit TOC will benefit from 10-year orphan market exclusivity in the European territory.