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Illuccix
Published
Product name
Illuccix
Active ingredient
Glu-urea-Lys(ahx)-hbed-CC
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Illuccix (Glu-urea-Lys(ahx)-hbed-CC) was approved for the following therapeutic use:
Illuccix, after radiolabelling with Ga-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging combined with computerised tomography (CT) in patients with prostate cancer:
- who are at risk of metastasis and who are suitable for initial definitive therapy.
- who have suspected recurrence based on elevated serum prostate specific antigen (PSA) level.
How this medicine works
Ga-68 Glu-urea-Lys(ahx)-hbed-CC binds to the prostate specific membrane antigen (PSMA) on cells that express PSMA including malignant prostate cancer cells, which overexpress PSMA. Gallium-68 (Ga-68) is a beta plus (β+) emitting radionuclide with an emission yield that allows positron emission tomography (PET) imaging.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), non-clinical (pharmacology and toxicology) and clinical (pharmacology, safety and efficacy) submitted by the sponsor. The benefit-risk profile of Illuccix was considered favourable for the therapeutic use approved.