← All approvals · Cancer · 2025
Grafapex (treosulfan)
The FDA approved Grafapex (treosulfan) on January 21, 2025 For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome.
- Brand name
- Grafapex
- Generic name
- treosulfan
- FDA approval date
- January 21, 2025
- Approved use (FDA wording)
- For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome
- Company
- Medexus
- Application
- NDA214759
- Dosage form / route
- POWDER · INTRAVENOUS
- Boxed warning on label
- Yes (see the FDA label)
- Category on this site
- Cancer
Indications and usage, from the FDA label
GRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). ( 1.1 ). Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS). ( 1.2 ). 1.1 Acute Myeloid Leukemia GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age an…