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Tuesday 22 January 2019
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ITG receives drug approval for EndolucinBeta®

ITM Isotopen Technologien München AG, a specialised radiopharmaceutical company, has announced that the European Medicines Agency (EMA) has granted marketing authorisation for EndolucinBeta® of ITM's subsidiary ITG Isotope Technologies Garching GmbH. This decision follows a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) in May of this year.

EndolucinBeta® respectively no-carrier-added (n.c.a.) Lutetium (177Lu) chloride is used in targeted radionuclide therapy, for example, in the field of precision oncology. It is a radiopharmaceutical precursor, used for radiolabelling of disease-specific carrier molecules, like antibodies or peptides. 177Lu has successfully been used for the treatment of inoperable or metastasised neuroendocrine tumors (NET) by radiolabelling with somatostatin analogues1 for example with the peptide DOTATOC (Edotreotide).2 Somatostatin receptors are predominantly overexpressed by NETs. The radiopharmaceutical, upon binding to the somatostatin receptor is in vivo internalised and retained by tumour 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 tumour is minimally affected.

Currently EndolucinBeta® is successfully used in investigational medicinal products for radiolabelling of peptides or antibodies. A recently published retrospective Phase II study with DOTATOC radiolabelled with EndolucinBeta® showed promising efficacy and safety data. These results suggest and demonstrate a significant benefit, a substantially improved progression-free survival (PFS), for which n.c.a. 177Lu-DOTATOC received an orphan designation (EMA/OD/196/13)3 as a treatment of gastro-entero-pancreatic neuroendocrine tumours (GEP-NET).4

Steffen Schuster, Chief Executive Officer of the ITM Group, commented: “We are very pleased that EndolucinBeta® has now received marketing authorisation. In the past promising results have already been achieved by combining EndolucinBeta® with disease-specific targeting molecules for radionuclide therapy especially with DOTATOC. In the future these encouraging results of n.c.a. 177Lu-DOTATOC need to be confirmed in a multi-centre Phase III study.”

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