CHMP positive for Theralugand (lutetium (177Lu) chloride) a radiopharmaceutical
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Theralugand, a radiopharmaceutical precursor.
Theralugand is not intended for direct use in patients and must be used only for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride. The applicant for this medicinal product is Eckert & Ziegler Radiopharma GmbH.
Theralugand will be available as a solution containing 40 GBq/ml radiopharmaceutical precursor. The active substance of Theralugand is lutetium (177Lu) chloride, a radioactive isotope of lutetium that emits beta-minus and gamma radiation (ATC code: V10X). The effect of Theralugand depends on the nature of the carrier medicine radiolabelled with the product.
The clinical utility of lutetium (177Lu) when attached to relevant carrier medicines was demonstrated based on an extensive review of the literature, for example in the treatment of patients with neuroendocrine tumours or prostate cancer. Unfavourable effects relating to radiation exposure can occur with Theralugand, as is the case with all radionuclides in clinical use. These effects, which include carcinogenicity and mutagenicity, will depend both on the radiation characteristics of lutetium (177Lu) in Theralugand and on the carrier medicine radiolabelled with lutetium (177Lu) (Theralugand).
In addition to radiation exposure for the patient, there is also a risk of radiation exposure for individuals in close proximity to the patient. A judgement on whether these risks are acceptable in any particular case can only be made in subsequent applications for carrier medicines intending to use Theralugand as a radiolabel.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.