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

DigiHealth

Astellas Collaborates with Concerto HealthAI on Real-World Evidence (RWE) Initiative

Shots: Astellas partners with Concerto HealthAI to uitilize Concerto’s RWD in order to track the response in patients with FLT3 mutation-positive r/r AML   The companies will utilize ASCO’s CancerLinQ Discovery database of de-identified cancer patient records to improve understanding of responses in patients, AML treatment patterns, disease progression and opportunities for improved QoL The […]Read More