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A conditioning chemotherapy given before donor stem-cell transplant in AML and MDS; it was long used in Europe and reached the US in 2025.
Treosulfan is a busulfan analogue that converts non-enzymatically to epoxides that alkylate DNA. It is myeloablative but carries lower hepatic and neurological toxicity than busulfan, which makes it suitable for conditioning older or comorbid patients before allogeneic stem-cell transplant. In the MC-FludT.14/L trial (Lancet Haematology 2020), treosulfan-fludarabine improved event-free and overall survival versus reduced-intensity busulfan-fludarabine in older or comorbid patients with AML or MDS. It was approved in the EU in 2019 for conditioning in adults and children and reached the US in 2025 as a preparative regimen for allogeneic transplant in AML and MDS with fludarabine. It has also been used in paediatric transplant and historically in ovarian cancer in Europe. The core idea is a gentler way to clear the marrow so a donor graft can take hold.
Prodrug converting non-enzymatically to epoxides that alkylate DNA; myeloablative with lower hepatic and neurotoxicity than busulfan.
1.Treosulfan slips into a pocket on its target.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Transplant conditioning given inpatient; paid within the Part A transplant stay.
Bundled into the transplant authorisation; centres seek approval as part of the allogeneic transplant episode.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Inpatient hospital care (Part A). Not medical or financial advice; verify with your plan.
Sources: NICE TA640. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
| Region | Year | Indication |
|---|---|---|
| EU | 2019 | Conditioning before allogeneic HSCT (with fludarabine) in adults and children |
| US | 2025 | Preparative regimen for allogeneic HSCT in AML/MDS with fludarabine |
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Query for this drug: (TITLE:"Treosulfan" OR ABSTRACT:"Treosulfan" OR TITLE:"Grafapex" OR ABSTRACT:"Grafapex") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Treosulfan, not a curated reading list.
Shares Allogeneic stem cell transplantation, Myelodysplastic syndromes / neoplasms (MDS), Acute myeloid leukaemia and the tag supportive.
Shares Allogeneic stem cell transplantation and the tag supportive.
Shares Allogeneic stem cell transplantation, Myelodysplastic syndromes / neoplasms (MDS), Acute myeloid leukaemia and the tag supportive.
Shares Myelodysplastic syndromes / neoplasms (MDS), Cytotoxic chemotherapy and the tag supportive.
Shares Acute myeloid leukaemia and the tag supportive.
Shares Cytotoxic chemotherapy and the tag supportive.
Shares Cytotoxic chemotherapy and the tag supportive.
Shares Myelodysplastic syndromes / neoplasms (MDS), Acute myeloid leukaemia, Cytotoxic chemotherapy.