Shots: The approval was based on P-III ADMIRAL assessing gilteritinib (120mg, qd) vs CT in 319 patients with relapsed or refractory AML. The study showed patients had significantly longer overall […]readmore
Tags : FLT3 Mutation
Shots: Gilteritinib is a FMS-like tyrosine kinase 3 (FLT3) and has inhibitory activity against FLT3-ITD which is a type of FLT3mut+ found in AML patients. Additionally, FLT3-ITD is a driver […]readmore
Shots: The approval is based on P-III ADMIRAL study assessing Xospata (120mg) vs salvage CT in 371 patients in a ratio (2:1) with r/r AML and FLT3 mutation in bone […]readmore
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 […]readmore
Shots: On 28 Nov, 2018 Xospata (gilteritinib) received FDA approval as a PO monothx, indicated for r/r FLT3 mutation-positive (FLT3mut+) AML Xospata is accompanied by Xospata Support Solutions offering access […]readmore