New Therapy Approved for Relapsed Leukemia
FDA approves Revuforj® for acute leukemia with KMT2A translocation, offering a new hope for patients.
The FDA has approved Revuforj® (revumenib) as the first menin inhibitor for relapsed or refractory acute leukemia with KMT2A translocation, applicable to patients aged one year and older. This breakthrough therapy demonstrated a 21% complete remission rate in the Phase 1/2 AUGMENT-101 trial, with median remission duration of 6.4 months and manageable safety outcomes. The approval provides a critical option for this aggressive leukemia subtype, marked by high relapse rates and poor survival outcomes.
Syndax plans a November U.S. launch for adult and pediatric doses, with expanded pediatric formulations expected in 2025.
My international experience as a researcher in Taiwan for three years has equipped me with a global perspective, enabling me to create content that resonates with an international audience.
Más de Pharma News
Todos los artículos →
Curia New York recibe una carta de advertencia de la FDA por miles de inyecciones cromatográficas no documentadas
Ab Science revisa los cronogramas de los ensayos tras tres inspecciones GCP
Discussion