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Trecondi
Published
Product name
Trecondi
Active ingredient
Treosulfan
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Trecondi (treosulfan) was approved for the following therapeutic use:
Adults with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)
Trecondi (treosulfan) is indicated in combination with fludarabine as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult patients with AML or MDS at increased risk for standard conditioning therapies.
Paediatric patients aged 1 month and older with malignant and non-malignant haematological diseases
Trecondi (treosulfan) is indicated in combination with fludarabine, with or without thiotepa, as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in paediatric patients older than one month with malignant and non-malignant diseases.
How this medicine works
Treosulfan is a prodrug of a bifunctional alkylating agent with cytotoxic activity to haematopoietic precursor cells. The activity of treosulfan is due to the spontaneous conversion into a mono-epoxide intermediate and L-diepoxybutane (see section 5.2 of Product Information).
The epoxides formed alkylate nucleophilic centres of deoxyribonucleic acid (DNA) and are able to induce DNA cross-links which are considered responsible for the stem cell depleting and antineoplastic effects.
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 Trecondi was considered favourable for the therapeutic use approved.
Sponsor