EU CHMP recommends approval of EndolucinBeta (no-carrier-added nca lutetium-177) for radiation therapy- ITG Isotope Technologies Garching

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product EndolucinBeta (no-carrier-added nca lutetium-177), from ITG Isotope Technologies Garching. This is a radiopharmaceutical precursor. EndolucinBeta is not intended for direct use in patients and must be used only for radiolabelling carrier molecules specifically developed to be used with EndolucinBeta.

Since EndolucinBeta is only intended for administration after conjugation to carrier molecules, no clinical data with the use of EndolucinBeta alone have been submitted. However, the clinical utility of EndolucinBeta when attached to relevant carrier molecules has been demonstrated, for example, in the molecular imaging and treatment of neuroendocrine tumours. Unfavourable effects relating to radiation exposure of the patient and other individuals in close proximity can occur with EndolucinBeta, as is the case with all radionuclides in clinical use. These effects, which include carcinogenicity and mutagenicity, will depend on the radiation characteristics of lutetium (177Lu) chloride in EndolucinBeta and on the carrier molecule to which EndolucinBeta is labelled. A judgement on whether the risk is acceptable in any particular case can only be made in subsequent applications for carrier molecules intending to use EndolucinBeta as a radiolabel.