FDA Approves Preparative Regimen for allo-HSCT in Patients With AML or MDS

The FDA has approved treosulfan (Grafapex, medac GmbH), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Efficacy was evaluated in MC-FludT.14/L Trial II (ClinicalTrials.gov. Identifier: NCT00822393), a randomized active-controlled trial comparing treosulfan versus busulfan with fludarabine as