TOKYO, December 3, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced the launch of the FLT3 (FMS-like tyrosine kinase 3) inhibitor XOSPATA® Tablet 40 mg (generic name: gilteritinib fumarate, “XOSPATA®”) in Japan for the indication of relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations.

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.It has also been seen that approximately 30 percent of patients with AML have mutations in a protein called FLT3, a receptor tyrosine kinase that is involved in the growth of cancer cells.

XOSPATA® is believed to suppress the growth of mutant tumor cells (ITD) by inhibiting mutations in two types of FLT3 mutations: internal tandem duplication and tyrosine kinase domain (TKD).

In October 2015, gilteritinib fumarate was granted SAKIGAKE2 designation for first relapsed or refractory AML with FLT3 mutations in Japan. In September 2018, it was approved for the indication of relapsed or refractory AML with FLT3 mutations based on the results of CR/CRh rate3 in the interim analysis of the multinational phase 3 ADMIRAL trial. It was also been approved for a similar indication in the United States on November 28, 2018 local time.

When administering XOSPATA®, a companion diagnostic (CDx) should be used to confirm that the patient is positive for the FLT3 mutation. This approach supports the promotion of precision medicine, which may provide optimal treatment for individual patients.

By providing XOSPATA® as a new treatment option, Astellas is contributing to the health of patients with AML and supporting healthcare professionals involved in the treatment of AML. 

Astellas reflected the impact from this launch in its financial forecasts of the current fiscal year ending March 31, 2019.