XOSPATA Is the First FDA-Approved Targeted Therapy for Relapsed or Refractory FLT3m+ AML That Inhibits ITD and TKD Mutations1

  • XOSPATA is a small molecule that inhibits multiple receptor tyrosine kinases, including FLT31
  • XOSPATA demonstrated the ability to inhibit FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 mutations, including1:
    • FLT3-ITD
    • FLT3-TKD (FLT3-D835Y)
    • FLT3-ITD and FLT3-TKD (FLT3-ITD-D835Y)
  • Additionally, XOSPATA induced apoptosis in leukemic cells expressing FLT3-ITD1

Mechanism of Action for XOSPATA2,3

Mechanism of Action for XOSPATA Mechanism of Action for XOSPATA
The clinical significance of the preclinical studies is unknown.
Select Safety Information

Posterior Reversible Encephalopathy Syndrome (PRES) 1% of 319 patients treated with XOSPATA in the clinical trials experienced posterior reversible encephalopathy syndrome (PRES) with symptoms including seizure and altered mental status. Symptoms have resolved after discontinuation of XOSPATA. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). Discontinue XOSPATA in patients who develop PRES.

AML=acute myeloid leukemia; FDA=Food and Drug Administration; FLT3=FMS-like tyrosine kinase 3; ITD=internal tandem duplication; m+=mutation-positive; TKD=tyrosine kinase domain.