dm+d

Unassigned

New Medicines

IlluzyceRadiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride

Information

Illuzyce
Radiopharmaceutical
Billev Pharma
Billev Pharma

Development and Regulatory status

None
Recommended for approval (Positive opinion)
None
Jul 22Recommended for EU approval by CHMP. 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 will be available as a solution containing 51.8 GBq/ml radiopharmaceutical precursor [2].

Category

A radioactive isotope of lutetium that emits beta- and gamma-radiation, used in the treatment of patients with neuroendocrine tumours or prostate cancer
Incidence of neuroendocrine tumours diagnosed during life is increasing, with the majority being gastrointestinal carcinoid tumours. Recent studies have estimated an annual incidence of approximately 3 per 100,000 per year [1].
Radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride
Intravenous infusion