FDA grants Priority Review to Supplemental NDA for Revuforj® (revumenib) in R/R mNPM1 AML; PDUFA action date Oct 2025
“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 in 2024,” said Michael A. Metzger, Chief Executive Officer. “Syndax is uniquely positioned to continue leading this exciting new therapeutic class with a first- and best-in-class menin inhibitor supported by compelling pivotal data across the broadest population of patients and a strong foundation already established among clinicians, payers, and other key stakeholders.”
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