Tags : Acute Myeloid Leukemia

Regulatory

Astellas’ Xospata (gilteritinib) Receives EC’s Approval as Monotherapy for Relapsed

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 […]Read More