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EMA CHMP recommends approval of SomaKit TOC (Netspot) in Positron Emission Tomography imaging in adult patients with gastro-enteropancreatic neuroendocrine tumours - Advanced Accelerator Applications

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Last updated:19th Sep 2016

Published:19th Sep 2016

Source: Pharmawand

The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product SomaKit TOC (Netspot), from Advanced Accelerator Applications, intended for use in Positron Emission Tomography (PET) imaging in adult patients with gastro-enteropancreatic neuroendocrine tumours (GEP-NET). SomaKit TOC was designated as an orphan medicinal product on 19 March 2015.

Comment: After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastro-enteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.

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