Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia
The FDA extended the PDUFA action date for Syndax Pharmaceuticals' NDA for revumenib, a treatment for relapsed or refractory KMT2Ar acute leukemia, to December 26, 2024, due to a major amendment submission. Revumenib aims to address significant unmet needs in KMT2A-rearranged acute leukemia patients.
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Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia
The FDA extended the PDUFA action date for Syndax Pharmaceuticals' NDA for revumenib, a treatment for relapsed or refractory KMT2Ar acute leukemia, to December 26, 2024, due to a major amendment submission. Revumenib aims to address significant unmet needs in KMT2A-rearranged acute leukemia patients.