TOKYO - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., 'Astellas') today announced the presentation of new data in acute myeloid leukemia (AML) at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 5-8, 2020.
Nine Astellas-sponsored abstracts focused on patients with AML with a positive FLT3 mutation (FLT3mut+) are being presented, comprising five oral presentations, three posters and one online-only presentation. Oral presentations include new data on the use of gilteritinib, either as monotherapy or in combination, across the FLT3mut+ AML patient spectrum - from those newly diagnosed, to relapsed or refractory patients who have been pre-treated with other tyrosine kinase inhibitors (TKIs) - as well as a secondary analysis of the Phase 3 ADMIRAL trial.
'The research being presented at ASH will shed light on critical unmet needs and continuing progress against AML, which remains a hard-to-treat cancer in spite of continuing medical advances,' said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. 'Several presentations will describe the effects of gilteritinib in a wide range of AML patients with a positive FLT3 mutation. We also look forward to discussing our Phase 3 LACEWING trial in progress, as well as findings from the STREAMLINE study related to real-world FLT3 testing rates in AML patients, both upon diagnosis and after relapse.'
Gilteritinib is approved as XOSPATA in the U.S. and selected other countries for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib. Gilteritinib is available as XOSPATA in the U.S., Japan and selected European countries, among others, for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.1 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 burden and poor prognosis, and FLT3-TKD mutations.2
About XOSPATA (gilteritinib) in the United States
XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.3
Astellas Pharma Inc., is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.
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