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Illuccix
ARTGs
356332, 356333
356332, 356333
Device/Product name
Illuccix
Active Ingredient
Glu-urea-Lys(ahx)-hbed-CC
Date of decision
Published
Submission type
New chemical entity
ATC codes
Not yet assigned
Decision
Approved
What was the decision based on
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.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application, evaluated through Priority Review.
| Description | Date |
|---|---|
| Positive Designation (priority) | 4 December 2020 |
| Submission dossier accepted and first round evaluation commenced | 27 November 2020 |
| Evaluation completed | 15 October 2021 |
| Delegate's Overall benefit-risk assessment and request for Advisory Committee advice | 31 August 2021 |
| Sponsor's pre-Advisory Committee response | 10 September 2021 |
| Sponsor's pre-Advisory Committee response | 10 September 2021 |
| Advisory Committee meeting | 30 September and 1 October 2021 |
| Registration decision (Outcome) | 1 November 2021 |
| Completion of administrative activities and registration on ARTG | 10 November 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 120 |
*Target timeframe for priority applications is 150 working days from acceptance for evaluation to the decision.
Date of entry onto ARTG
Original publication date
Black triangle scheme
No
Dose forms
Powder and diluent for injection
Strength
25 µg
Other ingredients
Mannose, sodium acetate, hydrochloric acid and water for injection
Containers
Vial
Pack sizes
One kit (containing Glu-urea-Lys(ahx)-hbed-CC vial, buffer vial (configuration A) and sterile vacuumed vial)One kit (containing Glu-urea-Lys(ahx)-hbed-CC vial, buffer vial (configuration B) and sterile vacuumed vial)
Routes of administration
Intravenous bolus
Dosage
Ga-68 Glu-urea-Lys(ahx)-hbed-CC is a radioactive drug and should be handled with appropriate safety measures to minimise radiation exposure (see Section 4.4 Special warnings and precautions for use in the Product Information).
The recommended amount of activity to be administered intravenously is 185 MBq (5 mCi) with a range of 166.5 to 203.5 MBq (4.5 to 5.5 mCi) and a maximum dose of 25 µg of Glu urea-Lys(ahx)-hbed-CC.
For further information refer to the Product Information.
Pregnancy category
This therapeutic good is exempted from pregnancy categorisation (not indicated for use in females).The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
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.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
- This approval does not impose any requirement for the submission of periodic safety update reports (PSURs). The sponsor should note that it is a requirement that all existing requirements for the submission of PSURs as a consequence of the initial registration or subsequent changes must be completed.
- For all injectable products the Product Information must be included with the product as a package insert.