Posted by Michael Wonder on 06 Feb 2025
FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and paediatric patients with AML or MDS
21 January 2025 - Today, the FDA approved treosulfan (Grafapex, medac), an alkylating agent, with fludarabine as a preparative regimen for allogeneic haematopoietic stem cell transplantation in adult and paediatric patients 1 year of age and older with acute myeloid leukaemia or myelodysplastic syndrome.
Efficacy was evaluated in MC-FludT.14/L Trial II, a randomised, active-controlled trial comparing treosulfan to busulfan with fludarabine as a preparative regimen for allogeneic transplantation.
