TOKYO, September 21, 2018 -Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that XOSPATA® Tablets 40 mg (generic name: gilteritinib), a FLT3 (FMS-like tyrosine kinase 3) inhibitor received manufacturing and marketing approval for the treatment of FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML) in Japan.
AML is a cancer that impacts the blood and bone marrow, and its incidence increases with age. In Japan, approximately 5,500 patients are diagnosed with AML each year1. XOSPATA® has demonstrated inhibitory activity against both internal tandem duplication (ITD) and tyrosine kinase domain (TKD), FLT3 mutations that are seen in approximately one-third of patients with AML.
This approval is based on the CR/CRh2 rate results from the interim analysis of the multinational Phase 3 ADMIRAL study. In October 2015, gilteritinib was designated as one of the first products in Japan to be included in the SAKIGAKE3 designation system. A similar application for approval was filed in the United States in March, 2018 and is currently under review.
With this approval, Astellas hopes to further contribute to the health of patients suffering from AML and to support healthcare professionals involved in the treatment of AML by providing new treatment options.
Astellas reflected the impact from this approval in its financial forecasts of the current fiscal year ending March 31, 2019.