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Lutetium (177Lu) Chloride
Published
Product name
Lutetium (177Lu) Chloride
Active ingredient
Lutetium (177Lu) chloride
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
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.
How this medicine works
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.
Why the TGA approved or did not approve this medicine
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.
ARTG details
- 352151