News | Radiopharmaceuticals and Tracers | May 11, 2016

EMA/CHMP Adopts Positive Opinion for ITM's EndolucinBeta

Radiopharmaceutical used in targeted radionuclide therapy for precision oncology

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:

Related Content

CORAR Supports Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018
News | Radiopharmaceuticals and Tracers | October 12, 2018
October 12, 2018 — The Council on Radionuclides and Radiopharmaceuticals Inc.
Huntsman Cancer Institute Installs First Preclinical nanoScan 3T PET/MRI in U.S.
News | PET-MRI | October 10, 2018
The Center for Quantitative Cancer Imaging at Huntsman Cancer Institute (HCI) at the University of Utah in Salt Lake...
Technology and Radionucleotide Development Will Fuel Mobile Gamma Camera Adoption
News | Nuclear Imaging | September 27, 2018
Advancements in healthcare technology, particularly in the surgery category, have led to an increasing adoption of...
Bruker Introduces New High-Performance Preclinical PET/CT Si78 System
Technology | PET-CT | September 26, 2018
September 26, 2018 — Bruker recently announced the introduction of the new preclinical...
Lightvision near-infrared fluorescence imaging system
News | Women's Health | September 11, 2018
Shimadzu Corp.
The Siemens Biograph Vision PET-CT system was released in mid-2018.

The Siemens Biograph Vision PET-CT system was released in mid-2018.

Feature | Nuclear Imaging | September 07, 2018 | By Dave Fornell
Nuclear imaging technology for both single photon emission computed tomography (SPECT) and positron emission tomography...
PET Imaging Agent Predicts Brain Tau Pathology, Alzheimer's Diagnosis
News | PET Imaging | September 05, 2018
Eli Lilly and Co. and Avid Radiopharmaceuticals Inc. announced a Phase 3 study of positron emission tomography (PET)...
Brain Study of 62,454 Scans Identifies Drives of Brain Aging
News | SPECT Imaging | August 27, 2018
In the largest known brain imaging study, scientists from five institutions evaluated 62,454 brain single photon...
Abnormal Protein Concentrations Found in Brains of Military Personnel With Suspected CTE

Researchers are using the tracer, which is injected into a patient, then seen with a PET scan, to see if it is possible to diagnose chronic traumatic encephalopathy in living patients. In this image, warmer colors indicate a higher concentration of the tracer, which binds to abnormal proteins in the brain. Credit UCLA Health.

News | PET Imaging | August 24, 2018
August 24, 2018 — In a small study of
PET Tracer Identifies Estrogen Receptor Expression Differences in Breast Cancer Patients
News | PET Imaging | August 09, 2018
In metastatic breast cancer, prognosis and treatment is largely influenced by estrogen receptor (ER) expression of the...