EMA Recommends Granting a Marketing Authorisation for Lutetium (177lu) Chloride

On 21 July 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product lutetium (177lu) chloride (Illuzyce), a radiopharmaceutical precursor. Illuzyce 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 Billev Pharma ApS.

Illuzyce will be available as a solution containing 51.8 GBq/ml radiopharmaceutical precursor. The active substance of Illuzyce is lutetium (177Lu) chloride, a radioactive isotope of lutetium that emits beta- and gamma-radiation (ATC code: V10X). The effect of Illuzyce depends on the nature of the carrier medicine radiolabelled with the product.

The clinical utility of 177lutetium 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 Illuzyce, 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) chloride in Illuzyce and on the carrier medicine to which the product is labelled.

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 Illuzyce as a radiolabel.

The full indication is:

  • Illuzyce is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride.
  • Illuzyce should be used by specialists experienced with in vitro radiolabelling.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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