ITM Isotopen Technologien München AG has announced that the European Medicines Agency (EMA) has granted Marketing Authorization for EndolucinBeta® of their 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, 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.
Currently EndolucinBeta® is successfully used in investigational medicinal products for radiolabeling of peptides or antibodies. A recently published retrospective Phase II study with DOTATOC radiolabeled 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) as a treatment of gastro-entero-pancreatic neuroendocrine tumors (GEP-NET).
Steffen Schuster, Chief Executive Officer of the ITM Group, commented: “We are very pleased that EndolucinBeta® now received Marketing Authorization. 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-center Phase III study.”