Drug intelligence / Profile preview

cytarabine + daunorubicin + gilteritinib

Development stage
Unknown
Lead developer
Astellas Pharma
Modality
Small Molecules
Administration
Intravenous, Oral
01

Overview

Cytarabine + daunorubicin (or idarubicin) + gilteritinib is a combination chemotherapy regimen used for the treatment of newly diagnosed FLT3-mutated acute myeloid leukemia (AML). This regimen integrates the standard '7+3' induction chemotherapy backbone—consisting of the antimetabolite cytarabine and an anthracycline (either daunorubicin or idarubicin)—with gilteritinib (Xospata), a potent oral small-molecule tyrosine kinase inhibitor. Gilteritinib selectively targets both internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations of the FMS-like tyrosine kinase 3 (FLT3) receptor, as well as the AXL kinase, which is associated with resistance to FLT3 inhibitors. The combination aims to provide synergistic antileukemic activity by combining broad cytotoxic effects with targeted inhibition of key survival pathways in FLT3-mutated blasts. It is currently being evaluated in Phase III clinical trials as a standard-of-care comparator against novel triplet regimens.

Brand names
Xospata
Other names
cytarabine + idarubicin + gilteritinib7+3 chemotherapy plus gilteritinib3+7 chemotherapy plus gilteritinibstandard chemotherapy plus gilteritinib
02

Targets

AXL (AXL receptor tyrosine kinase)DNATOP2A (DNA topoisomerase II)FLT3 (Fms related receptor tyrosine kinase 3)

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