Posted by Michael Wonder on 25 Jun 2025
Syndax announces FDA priority review of sNDA for Revuforj (revumenib) in relapsed or refractory mNPM1 acute myeloid leukaemia
24 June 2025 - Syndax Pharmaceuticals today announced that the US FDA has granted priority review for its supplemental new drug application for Revuforj (revumenib) for the treatment of relapsed or refractory mutant NPM1 acute myeloid leukaemia.
The supplemental new drug application is being reviewed under the FDA's Real-Time Oncology Review program and has been assigned a PDUFA target action date of 25 October 2025.
