Gilteritinib (XOSPATA) is the ONLY Category 1 recommendation for patients with relapsed or refractory AML with a FLT3 mutation in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)1


In Relapsed or Refractory FLT3m+ AML,* XOSPATA Is the Only FDA-Approved Targeted Monotherapy to Deliver Superior Overall Survival vs Salvage Chemotherapy2,3

reduced risk of death
with XOSPATA (n=247)2

vs salvage chemotherapy (n=124); HR=0.64 (95% CI: 0.49, 0.83); P=0.00042

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)2

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*FLT3 mutation status: FLT3-ITD, FLT3-TKD, and FLT3-ITD-TKD.2

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.2

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; NCCN=National Comprehensive Cancer Network; OS=overall survival; TKD=tyrosine kinase domain.

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.1.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed 12-03-2021. To view the most recent and complete version of the guideline, go online to NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 3. 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.