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Astellas' Xospata (gilteritinib) Receives EC's Approval as Monotherapy for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

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Astellas' Xospata (gilteritinib) Receives EC's Approval as Monotherapy for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

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  • The approval is based on P-III ADMIRAL study assessing Gilteritinib as monothx. vs salvage CT In patients with relapsed or refractory FLT3mut+ AML. The approval follows EMA’s accelerated assessment and ODD which reduced the timeframe for approval
  • The P-III ADMIRAL study resulted in longer OS i.e- mOS (9.3 vs 5.6mos.); rates of one-year survival (37% vs 17%)
  • Xospata is an AXL receptor tyrosine kinase inhibitor- has the potential to improve treatment for patients with AML having FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD) mutation

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