Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia

Core Points - The FDA has extended the PDUFA action date for revumenib to December 26, 2024, allowing additional time for review [1][3][8] - Revumenib is positioned to be the first drug approved for treating KMT2A-rearranged acute leukemia, addressing a significant unmet medical need [1][10] - The drug has received multiple designations from the FDA, including Breakthrough Therapy, Fast Track, and Orphan Drug designations [9][10] Company Overview - Syndax Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative cancer therapies [8][10] - The company's pipeline includes revumenib, a selective inhibitor targeting the menin-KMT2A binding interaction, and axatilimab, a monoclonal antibody [5][10] Regulatory Process - Revumenib's NDA is under the FDA's Real-Time Oncology Review (RTOR) program, which facilitates a more efficient review process for oncology drugs [9][5] - The FDA's request for additional information constituted a Major Amendment to the NDA, resulting in a standard three-month extension [3][8]