Shots:

• The approval is based on results of P-III ADMIRAL trial assessing Xospata (120 mg-qd ) vs salvage CT in ≥371 patients in ratio (2:1) with FLT3 mutations who are refractory to or have relapsed after 1L AML therapy
• P-III ADMIRAL trial results: CR/CRh 21%- median duration of CR/CRh 4.6 mos.- rate of conversion from transfusion dependence to transfusion independence was 31.1%; patients achieving CR/CRh: median response rate 3.6 mos.- CR/CRh with FLT3-ITD or FLT3- ITD/TKD 29%- only FLT3-TKD 0%
• Xospata is a FLT3 inhibitor- indicated for r/r AML in adults and jointly developed by Astellas and Kotobuki Pharmaceutical

Ref: Astellas | Image: Astellas