EMA Prematurely Announced Opinion on SomaKit TOC® Kit Application


AAA announced today that the European Medicines Agency (EMA) prematurely notified the public and the company of its opinion on the Marketing Authorization Application for SomaKit TOC®, 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 EMA posted the following statement on its website: “The adoption of the CHMP opinion for SomaKit TOC was included in the CHMP highlights in error. This opinion has now been removed from the highlights as this procedure is still ongoing. Once the procedure is finalised, EMA will communicate its outcome.”

SomaKit TOC® is composed of both a medicinal product and a device component. Finalization of the opinion on the kit is subject to the device component being certified by the relevant notified body. This requirement should have no impact on the benefit-risk assessment of the product. Once it has been fulfilled, the EMA will issue its final opinion on SomaKit TOC®.

We are actively collaborating with the EMA staff to move forward as quickly as possible,” said Stefano Buono, Chief Executive Officer of AAA.