Revuforj is approved for relapsed or refractory acute leukemia with KMT2A translocation in patients aged 1 year and older. The AUGMENT-101 trial showed a 21.2% complete remission rate with a median ...

“We are pleased that the FDA has granted Priority Review to our sNDA in R/R mNPM1 AML, a filing which builds on the initial approval of Revuforj for R/R acute leukemia with a KMT2A translocation ...