Astellas’ Xospata (gilteritinib) Receives FDA ‘s Approval for 1L R/R Acute Myeloid Leukemia (AML) in Adults

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

Click here to read full press release/ article | Ref: Astellas | Image: Merger