4 August 2016 - ITM Isotopen Technologien München AG today announced that the EMA has granted marketing authorization for EndolucinBeta of ITM´s subsidiary ITG Isotope Technologies Garching GmbH. This decision follows a positive recommendation from the European CHMP in May of this year.

EndolucinBeta respectively no-carrier-added (n.c.a.) Lutetium (177Lu) chloride is used in targeted radionuclide therapy, e.g. in the field of precision oncology. It is a radiopharmaceutical precursor, used for radiolabeling of disease-specific carrier molecules, like antibodies or peptides. 177Lu has successfully been used for the treatment of inoperable or metastasized neuroendocrine tumors (NET) by radiolabeling with Somatostatin analogues for example with the peptide Dotatoc (edotreotide).

Somatostatin receptors are predominantly overexpressed by NETs. The radiopharmaceutical, upon binding to the Somatostatin receptor is in vivo internalized and retained by tumor cells. Upon decay, 177Lu emits cytotoxic medium-energy beta particles with a maximum range of 1.7 mm in soft tissue, which means that healthy tissue in the surroundings of the targeted tumor is minimally affected.

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