On December 5, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that new data evaluating XOSPATA (gilteritinib) across FMS-like tyrosine kinase 3 mutation-positive (FLT3m+) acute myeloid leukemia (AML), including in relapsed or refractory (R/R), newly diagnosed and post-transplant maintenance settings, will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place from 6-9 December 2025 in Orlando, Fla.
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Through ongoing research with gilteritinib, Astellas is advancing the science of FLT3m+ AML and generating new evidence across the disease stages, to help improve long-term outcomes for people diagnosed with FLT3m+ AML.
Highlights from Astellas at ASH (Free ASH Whitepaper) 2025 will include:
A pooled post-hoc analysis of the Phase 3 ADMIRAL and COMMODORE trials evaluating gilteritinib in R/R FLT3m+ AML, exploring treatment sequencing and resumption post-transplant to improve outcomes.
In collaboration with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), data from a post-hoc analysis of the Phase 3 MORPHO study examining how time from diagnosis to transplant, use of FLT3 inhibitors before transplant and use of gilteritinib post-transplant influenced outcomes in FLT3m+ AML.
Results from the ongoing Phase 1/2 VICEROY study (NCT05520567) investigating triplet combination therapy approach including gilteritinib in newly diagnosed FLT3m+ AML patients ineligible for intensive chemotherapy, focused on safety, efficacy and dosing optimization.
Moitreyee Chatterjee-Kishore, PhD, MBA, Head of Oncology Development, Astellas
"Building on gilteritinib’s foundation in treating relapsed or refractory FLT3-mutated AML – one of the most challenging forms of leukemia characterized by high rates of treatment failure and relapse – Astellas is dedicated to advancing research that provides valuable insights to inform clinical practice. This new data exemplifies our ‘bench to bedside’ approach, translating scientific innovation into VALUE for patients who urgently need new treatment options."
Astellas Presentations at ASH (Free ASH Whitepaper) 2025
Presentation Title
Presenter
Presentation Details
Outcomes of patients with
relapsed/refractory FLT3mut+
Acute Myeloid Leukemia who
resumed gilteritinib therapy after
HSCT: Post hoc analysis from the
ADMIRAL and COMMODORE
trials
J. Wang
Type: Oral
Presentation ID: 45
Date: December 6, 10:45 – 11:00 EST
Venetoclax (VEN) and azacitidine
(AZA) with gilteritinib (GILT) in
patients with newly diagnosed (ND)
FLT3mut+ Acute Myeloid
Leukemia (AML) ineligible for
intensive induction chemotherapy
(chemo): Interim results from the
phase 1/2 VICEROY study
J. Altman
Type: Oral
Presentation ID: 654
Date: December 7, 17:45 – 18:00 EST
Time from AML diagnosis to HCT
and pre-HCT FLT3 inhibition
impact pre-transplant MRD and
benefit from post-HCT gilteritinib
(In collaboration with BMT CTN)
M. Levis
Type: Oral
Presentation ID: 1058
Date: December 8, 16:45 – 17:00 EST
A 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 study
Y. Ishikawa
Type: Oral
Presentation ID: 998
Date: December 8, 16:45 – 17:00 EST
Transfusion burden among older
US patients with relapsed FLT3-
mutated Acute Myeloid Leukemia
treated with gilteritinib: A Medicare
claims-based cohort study
T. LeBlanc
Type: Poster
Presentation ID: 1664
Date: December 6, 17:30 – 19:30 EST
Maintenance treatment with
gilteritinib suppresses post-
transplant relapse in
relapsed/refractory FLT3-mutated
acute myeloid leukemia: A
Japanese nationwide registry study
Y. Arai
Type: Poster
Presentation ID: 4289
Date: December 7, 18:00 – 20:00 EST
Investigator Sponsored Research Presentations at ASH (Free ASH Whitepaper) 2025
Presentation Title
Presenter
Presentation Details
Long-term follow-up of azacitidine,
venetoclax, and gilteritinib in
patients with newly diagnosed
FLT3-mutated Acute Myeloid
Leukemia
RS. Azevedo
Type: Oral
Presentation ID: 45
Date: December 6, 10:00 – 10:15 EST
A phase II study of azacitidine,
venetoclax, and gilteritinib for
newly diagnosed adverse risk
FLT3-wild type acute myeloid
leukemia
S. Arora
Type: Poster
Presentation ID: 5226
Date: December 8, 18:00 – 20:00 EST
Gilteritinib is a FLT3 inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high disease burden and poor prognosis, and FLT3-tyrosine kinase domain (TKD) mutations.1 Gilteritinib is available as XOSPATA across the world, including in the U.S., Japan, China and multiple European countries for the treatment of adult patients who have relapsed or refractory FLT3m+ AML.
The ongoing, randomized, multicenter, open-label, Phase 3 PASHA study (NCT04027309) is evaluating gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one year of maintenance in patients with newly diagnosed FLT3-mutated AML eligible for intensive chemotherapy.
About Gilteritinib
Gilteritinib is an FMS-like tyrosine kinase 3 (FLT3) inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high disease burden and poor prognosis, and FLT3-TKD mutations.1 It was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global development, commercialization and manufacturing rights to gilteritinib.2
Gilteritinib was evaluated in ADMIRAL (NCT02421939), a Phase 3, open-label, multicenter, randomized clinical trial comparing gilteritinib with prespecified salvage chemotherapy in adult patients with relapsed or refractory FLT3-mutated AML.
About Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) is an aggressive cancer that affects the bone marrow and blood, and its incidence increases with age.3,4 Of patients newly diagnosed with AML and tested for FLT3 mutations, approximately one-third have an alteration to the FLT3 gene. FLT3-ITD mutations have been associated with worsened disease-free survival and overall survival, and a higher risk of getting the disease more than once. FLT3 mutation status can change over the course of AML treatment, even after relapse.
(Press release, Astellas, DEC 5, 2025, View Source [SID1234661177])