May 11, 2016 — ITM (Isotopen Technologien München AG), a specialized radiopharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) , has adopted a positive opinion on the Marketing Authorization Application (MAA) for EndolucinBeta. The radiopharmaceutical is a product of ITM´s subsidiary ITG Isotope Technologies Garching GmbH. CHMP is part of the European Medicines Agency (EMA).
EndolucinBeta, respectively 177Lutetium chloride, is used in targeted radionuclide therapy in the field of precision oncology. It is a radiopharmaceutical precursor, used for the radiolabeling of carrier molecules, such as peptides, monoclonal antibodies, vitamins or other substrates. The active substance of EndolucinBeta is no-carrier-added (n.c.a.) Lutetium (177Lu) chloride, a radioactive isotope of Lutetium that emits predominantly beta radiation. 177Lutetium has a half-life of 6.7 days.
The clinical utility of EndolucinBeta when attached to relevant carrier molecules has already been demonstrated in receptor-targeted radionuclide therapies. Biomolecules radiolabeled with n.c.a. 177Lutetium bind to specific receptors on the tumor’s surface. Subsequently they deposit cytotoxic doses of ionizing radiation precisely at the tumorsite by means of transmitting low-energy beta particles. 177Lutetium reaches cells within a maximum of a 1.7 mm radius, which means that toxicity is highly localized and healthy tissue in the surroundings of the targeted tumor is minimally affected.
ITM has developed a unique methodology to produce n.c.a. 177Lutetium, which provides the highest specific activity, highest purity and the best preconditions for radiolabeling biomolecules. Furthermore, n.c.a. 177Lutetium features the highest achievable radionuclide purity (no metastable longlived 177m-Lutetium impurity). This ensures effective and economical waste management and environmental sustainability as compared to alternative forms and production routes of the 177Lutetium radioisotope.
EndolucinBeta will be available with an activity concentration of 40 GBq/ml at ART (activity reference time) as a solution with a total content of 3 - 150 GBq Lutetium (177Lu).
For more information: www.ema.europa.eu/ema