Astellas To Present New Data on XOSPATA™ (gilteritinib) Across the FLT3m+ AML Disease Continuum at ASH 2025 Annual Meeting

Core Insights - Astellas Pharma is presenting new data on gilteritinib for FLT3m+ acute myeloid leukemia (AML) at the American Society of Hematology (ASH) Annual Meeting, focusing on various treatment settings including relapsed or refractory cases and post-transplant maintenance [1][2] Group 1: Research and Development - Ongoing research with gilteritinib aims to improve long-term outcomes for patients with FLT3m+ AML, particularly in challenging cases characterized by high treatment failure rates [2] - The Phase 3 ADMIRAL and COMMODORE trials provide pooled post-hoc analysis on gilteritinib's effectiveness in relapsed or refractory FLT3m+ AML, emphasizing treatment sequencing and resumption post-transplant [4] - The Phase 1/2 VICEROY study is investigating a triplet combination therapy approach with gilteritinib for newly diagnosed FLT3m+ AML patients who are ineligible for intensive chemotherapy, focusing on safety and efficacy [4] Group 2: Presentations at ASH 2025 - Key presentations include outcomes of patients who resumed gilteritinib therapy after hematopoietic stem cell transplant (HSCT) and interim results from the VICEROY study [3][5] - A presentation will discuss the impact of pre-HCT FLT3 inhibition on minimal residual disease (MRD) and the benefits of post-HCT gilteritinib [5] - Additional studies will cover the long-term follow-up of azacitidine, venetoclax, and gilteritinib in newly diagnosed FLT3-mutated AML patients [6] Group 3: Product Information - Gilteritinib, marketed as XOSPATA, is an FLT3 inhibitor effective against FLT3-ITD and FLT3-TKD mutations, which are associated with poor prognosis in AML [8][10] - XOSPATA is available globally, including in the U.S., Japan, China, and several European countries, for adult patients with relapsed or refractory FLT3m+ AML [8][13]