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Lutetium (177Lu) Chloride

Device/Product name
Lutetium (177Lu) Chloride
Active Ingredient
Lutetium (177Lu) chloride
Date of decision
Published
Submission type
New chemical entity
ATC codes
V10X
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Lutetium (177Lu) chloride 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.

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

Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Dose forms
Radiochemical solution
Strength
10 to 200 GBq/mL
Other ingredients
Dilute hydrochloric acid and water for injections
Containers
Vial
Pack sizes
One vial
Routes of administration
Lutetium chloride should not be administered directly to the patient. Lutetium is intended for in vitro radiolabelling of medicinal products which are subsequently administered by the approved route.
Dosage

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.

Pregnancy category
XDrugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.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

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.
What is this medicine and how does it work
Lutetium chloride emits β-particles of moderate maximum energy (0.498 MeV) with a maximum tissue penetration of approximately 2 mm (mean penetration range of 0.67 mm), which is sufficient to kill targeted tumour cells with a limited effect on neighbouring normal cells, thus minimising potential toxicity.
What post-market commitments will the sponsor undertake
  • 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.

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