The Response
No One Saw
Coming

In Patients With Relapsed or Refractory FLT3m+ AML,* XOSPATA Demonstrated1:

21.0% CR/CRh
(95% CI: 14.5, 28.8; n=29/138)
mDOR=4.6 months
(range: 0.1 to 15.8 months)

31.1% Patients who converted to transfusion independence during any 56-day post-baseline period, among patients who were transfusion dependent at baseline (n=33/106)
Select Safety Information

Posterior Reversible Encephalopathy Syndrome (PRES) There have been rare reports of PRES with symptoms including seizure and altered mental status with XOSPATA. Symptoms have resolved after discontinuation of XOSPATA. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XOSPATA in patients who develop PRES.

*FLT3 mutation status: FLT3-ITD, FLT3-TKD.1

CR defined as normal marrow differential with <5% blasts, ANC ≥1.0 x 109/L and platelets ≥100 x 109/L, no evidence of extramedullary leukemia, and must have been RBC and platelet transfusion independent.1

CRh defined as marrow blasts <5%, partial hematologic recovery, ANC ≥0.5 x 109/L and platelets ≥50 x 109/L, no evidence of extramedullary leukemia, and could not have been classified as CR.1

AML=acute myeloid leukemia; ANC=absolute neutrophil count; CI=confidence interval; CR=complete remission; CRh=complete remission with partial hematologic recovery; FLT3=FMS-like tyrosine kinase 3; ITD=internal tandem duplication; m+=mutation-positive; mDOR=median duration of CR/CRh; RBC=red blood cell; TKD=tyrosine kinase domain.

Reference:

  1. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc.