Astellas To Present New Data on XOSPATA (gilteritinib) Across the FLT3m+ AML Disease Continuum at ASH 2025 Annual Meeting
December 5, 2025 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – ASH 2025, Astellas, acute myeloid leukaemia, clinical trials, relapsed or refractory multiple myeloma
- Presentations include pooled post-hoc analysis of the Phase 3 ADMIRAL and COMMODORE data on post-transplant gilteritinib resumption in relapsed or refractory FLT3m+ AML
- Findings from the Phase 3 MORPHO trial in the post-transplant maintenance setting and Phase 1/2 VICEROY trial in newly diagnosed disease highlight how treatment timing, sequencing and combination approaches may influence outcomes.
5 December 2025 — Tokyo, Japan — Astellas Pharma Inc today announced 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) Annual Meeting taking place from 6-9 December 2025 in Orlando, Fla. 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 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 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 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 Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women’s health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
