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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