The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ (Nasdaq: SNDX) Revuforj (revumenib).
Coming ahead of the original FDA’s decision date of December 25, Revuforj is the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.
This marks the second FDA drug approval this year for the company adding to Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD), which was developed with Incyte Corp (Nasdaq: INCY).
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