Astellas Pharma Inc.’s Xospata (gilteritinib) has received its first approval globally, in Japan for FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML), marking the first commercial entry of another option in the increasingly competitive AML space as a varied range of new therapies move to market.
The oral FLT3 (FMS-like tyrosine kinase 3) inhibitor was filed for approval in the indication in Japan only in March, around the same time that it was submitted for the same use in the US, where the FDA has granted orphan designation for