Treosulfan with fludarabine approval – The Babak Lab
The Babak Lab shared a post on LinkedIn:
“Clinical Mondays: Treosulfan with fludarabine approval.
On January 21, 2025, the FDA approved treosulfan (Grafapex, medac GmbH) in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients (1 year and older) with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Efficacy & Safety Highlights:
The approval was based on the MC-FludT.14/L Trial II (NCT00822393), a randomized, active-controlled study comparing treosulfan to busulfan, both in combination with fludarabine. Key findings include:
– Improved Overall Survival (OS): Treosulfan demonstrated a hazard ratio of 0.67 (95% CI: 0.51, 0.90) compared to busulfan, with consistent benefits observed in both AML and MDS subgroups.
– Safety Profile: The most common adverse reactions (≥20%) included musculoskeletal pain, stomatitis, pyrexia, nausea, edema, infection, and vomiting.
Why This Matters:
This approval provides a new, effective, and well-tolerated preparative regimen for patients undergoing alloHSCT, offering hope for improved outcomes in both adults and children with AML or MDS.
For more details, the full prescribing information will be available on Drugs@FDA.”
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