Tags : Xospata

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

Pharma

Astellas to Launch Xospata (gilteritinib) for R/R Acute Myeloid Leukemia

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 and reimbursement support to patients and also provides information regarding patient healthcare coverage options and financial assistance programs Xospata 40 mg (gilteritinib) is a FLT3 […]Read More