ITM Isotopen Technologien München AG, a specialized radiopharmaceutical company, announced that the European Medicines Agency (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 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).
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Source: ITM Isotopen Technologien Muenchen AG