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# FDA Approves Medexus Leukemia NDA
- URL: https://www.fdaweb.com/fda-approves-medexus-leukemia-nda/
- Published: 2025-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:51:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158540

FDA has approved a Medexus NDA for Grafapex (treosulfan), an injectable alkylating agent for use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients with acute myeloid leukemia (AML) or myelodysplastic syndrome.

Approval was based on data from Phase 3 MC-FludT.14/L Trial II (NCT00822393) that compared treosulfan plus fludarabine vs busulfan plus fludarabine as a preparative regimen for alloHCT, according to the company. Data showed that the treosulfan arm had a 33% reduction in the risk of death in the overall population vs those in the control arm, it says, adding that an overall survival benefit was seen in patients with AML.