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

Shots:

• 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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