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

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

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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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