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December 8, 2025BloodOpen Access

Real-world effectiveness of gilteritinib beyond second-line therapy in relapsed/refractory FLT3-mutated acute myeloid leukemia: A european multicenter study of 171 patients

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Authors

GMGema MirallesJBJuan BerguaFCFerran Vall‐Llovera Calmet

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Overview

Multicenter analysis reveals gilteritinib improves overall survival in relapsed/refractory acute myeloid leukemia, indicating its potential beyond second-line therapy.

Key Points

  • Gilteritinib treatment improved overall survival to a median of 7.1 months in patients with acute myeloid leukemia, suggesting efficacy in later-line settings.
  • Responses were noted, with complete remission rates at 28% and overall response rates at 47%, highlighting its potential in challenging cases.
  • Multicenter, retrospective cohort analysis included 171 patients receiving gilteritinib after multiple therapies, indicating a need for optimized sequencing.
  • Findings support ongoing gilteritinib use beyond second-line therapy, particularly as a bridge to allogeneic hematopoietic stem cell transplant.

Cite This Study

Miralles et al. (2025) studied this question.

synapsesocial.com/papers/69362f764fa91c937236e3aahttps://doi.org/10.1182/blood-2025-1662
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Gilteritinib in FLT3‐mutated acute myeloid leukemia: A real‐world Italian experience2025 · 6 citations
  2. 2A Phase 2 study of sequential administration of gilteritinib after MEC chemotherapy in Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia in adults: Japan adult leukemia study group (JALSG) RR-FLT3-AML220 study2025
  3. 3Efficacy of the triplet therapy with venetoclax, azacitidine and gilteritinib for the treatment of FLT3-ITD mutated AML patients with refractory/relapsed disease or persistent minimal residual disease bridging to allogeneic hematopoietic stem cell transplantation2025 · 2 citations
  4. 4Gilteritinib maintenance therapy after allogeneic hematopoietic stem cell transplantation in FLT3-mutated AML: A systematic review and meta-analysis2025
  5. 5Maintenance treatment with gilteritinib suppresses post-transplant relapse in relapsed/refractory FLT3-mutated acute myeloid leukemia: A Japanese nationwide registry study2025