- Results were published online and in the October 31 print edition of the Journal -

TOKYO, October 31, 2019 - The New England Journal of Medicine published detailed results from the Phase 3 ADMIRAL trial, which found that Astellas Pharma Inc.’s (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) XOSPATA® (gilteritinib) demonstrated significantly longer Overall Survival (OS) than salvage chemotherapy in adult patients with relapsed (disease that has returned) or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation. Common adverse events from the study of grade 3 or higher in the gilteritinib group were febrile neutropenia (45.9%), anemia (40.7%), and thrombocytopenia (22.8%).1 The results appear in the October 31 print edition of the Journal and are currently available online.1

“These data show that in a very high-risk leukemia population, single agent FLT3-targeted therapy leads to superior clinical outcomes compared to salvage chemotherapy,” said Alexander Perl, MD, associate professor of Hematology-Oncology in the Abramson Cancer Center at the University of Pennsylvania, and the trial’s principal investigator. “This is an important result for patients who previously had quite limited treatment options.”

“The detailed findings from our Phase 3 ADMIRAL trial further validate that XOSPATA is a significant addition to the treatments available for people with FLT3 mutation positive relapsed or refractory AML,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas. “We are especially pleased to see the results published in the New England Journal of Medicine, which is widely regarded as one of the most prestigious scientific medical journals.” 

The U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) in May of 2019 to update the U.S. product labeling for XOSPATA to include final analysis OS data from the ADMIRAL trial.2

XOSPATA was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize XOSPATA.

XOSPATA was approved by the Japan Ministry of Health, Labor and Welfare (MHLW) for relapsed or refractory AML with FLT3 mutations and launched as XOSPATA® 40 mg Tablets in 2018.3  In October 2019, the European Commission (EC) approved XOSPATA as a monotherapy for the treatment of adult patients with relapsed or refractory AML with a FLT3 mutation.4 XOSPATA has been designated an orphan medicinal product and also received accelerated assessment from the European Medicines Agency (EMA) earlier this year, which reduced the timeframe for approval.5,6,7 Astellas is currently investigating gilteritinib in various FLT3 mutation-positive AML patient populations through several clinical trials. Visit http://www.clinicaltrials.gov to learn more about ongoing gilteritinib clinical trials.


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