Lutetium (177Lu) Chloride
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Designation; Orphan | 22 January 2020 |
| Orphan extension | 26 August 2020 |
| Submission dossier accepted and first round evaluation commenced | 20 January 2021 |
| First round evaluation completed | 16 July 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 1 September 2021 |
| Second round evaluation completed | 7 October 2021 |
| Delegate's overall benefit-risk assessment | 1 December 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 8 December 2021 |
| Completion of administrative activities and registration on ARTG | 11 January 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 189 |
*Statutory timeframe for standard applications is 255 working days
Lutetium chloride is only to be used by specialists experienced with peptide receptor radionuclide therapy (PRRT).
The quantity of lutetium (177Lu)-labelled PRRT that is subsequently administered will depend on the carrier molecule to be radiolabelled and its intended use.
The radiation dose received by various organs following intravenous administration of a lutetium (177Lu)- labelled PRRT is also dependent on the specific molecule being radiolabelled.
For further information refer to the Product Information.
Lutetium (177Lu) Chloride (lutetium (177Lu) chloride) was approved for the following therapeutic use:
Lutetium (177Lu) chloride is a radiopharmaceutical precursor, and it is not intended for direct use in patients. For the treatment of non resectable or metastatic neuroendocrine tumours (NETS) expressing somatostatin subtype 2 receptors when coupled with a suitable carrier molecule.
- Lutetium (177Lu) chloride is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Lutetium (177Lu) chloride must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Lutetium (177Lu) Australian (AU)-risk management plan (RMP) (version 0.2, dated 6 October 2021, data lock point 15 December 2020), included with submission PM-2020-06691-1-4 and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the European Union (EU) during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on good pharmacovigilance practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
- For all injectable products the PI must be included with the product as a package insert.