In Relapsed or Refractory FLT3m+ AML,* XOSPATA Is the Only FDA-Approved Targeted Monotherapy to Deliver Superior Overall Survival vs Salvage Chemotherapy1,2

reduced risk of death
with XOSPATA (n=247)1

vs salvage chemotherapy (n=124); HR=0.64 (95% CI: 0.49, 0.83); P=0.00041

9.3 months median OS with XOSPATA (95% CI: 7.7, 10.7) vs 5.6 months with salvage chemotherapy (95% CI: 4.7, 7.3)1

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

The OS endpoint was measured from the date of randomization until death by any cause in the final analysis, which included 371 patients randomized 2:1 to receive XOSPATA or a prespecified salvage chemotherapy regimen.1

AML=acute myeloid leukemia; CI=confidence interval; FDA=Food and Drug Administration; FLT3=FMS-like tyrosine kinase 3; HR=hazard ratio; ITD=internal tandem duplication; m+=mutation-positive; OS=overall survival; TKD=tyrosine kinase domain.

References: 1. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 2. Ballesta-López O, Solana-Altabella A, Megías-Vericat JE, Martínez-Cuadrón D, Montesinos P. Gilteritinib use in the treatment of relapsed or refractory acute myeloid leukemia with a FLT3 mutation. Future Oncol (Epub) 09-25-2020.