BRIEF—Astellas launches AML drug Xospata in Japan

Japanese major Astellas Pharma has launched its FLT3 (FMS-like tyrosine kinase 3) inhibitor Xospata (gilteritinib fumarate) 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, around 5,500 patients are diagnosed with AML each year1.It has also been seen that approximately 30% 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 SAKIGAKE 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 rate in the interim analysis of the multinational Phase III ADMIRAL trial. It was also been approved for a similar indication in the USA on November 28, 2018 local time.