First Approval Globally For Gilteritinib, In Japan For AML

28 Sep 2018

First nod globally for Astellas's FLT3 inhibitor set to further increase competition in AML space, but commercial opportunity in launch market Japan looks set to be limited.

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background. — FIRST APPROVAL FOR ASTELLAS'S AML DRUG, IN JAPAN • Source: Shutterstock

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,...