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Syndax to Initiate NDA Submission of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Under FDA's Real-Time Oncology Review Program
– Solidifies first-to-market potential for revumenib – – High unmet need in relapsed or refractory KMT2Ar patients in the U.S. provides a strong foundation
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– Solidifies first-to-market potential for revumenib –\n– High unmet need in relapsed or refractory KMT2Ar patients in the U.S. provides a strong foundation for revumenib commercial launch –\nWALTHAM, Mass., Oct. 24, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the Company will submit a New Drug Application (NDA) for revumenib in relapsed or refractory (R/R) KMT2Ar acute leukemia, including acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL), under the U.S. Food and Drug Administration (FDA) Real-Time Oncology Review (RTOR) program. Revumenib is the Company's highly selective oral menin inhibitor.\n\nDuring the Company's pre-NDA meeting, the FDA indicated that it would review the revumenib NDA submission for adult and pediatric KMT2Ar acute leukemia under the Oncology Center of Excellence RTOR Program. Inclusion in the RTOR program follows the previously announced FDA Breakthrough Therapy Designation (BTD) for the same indication and recent positive topline data from the AUGMENT-101 pivotal trial in R/R KMT2Ar acute leukemia. Syndax plans to initiate the NDA submission imminently and expects to complete the submission by year-end 2023.\n\"On the heels of announcing positive pivotal data earlier this month, we are delighted the FDA has agreed to review the application under the RTOR program, underscoring the urgent unmet need and the substantial improvement over available therapies that revumenib may offer to this underserved patient population,\" said Michael A. Metzger, Chief Executive Officer of Syndax. \"Working with the FDA, we designed an innovative strategy to bring revumenib to the broadest population of KMT2Ar patients – adults and pediatrics, AML and ALL – as rapidly as possible. Syndax is in an excellent position to launch revumenib and axatilimab, two first- and best-in-class agents, in 2024 and deliver on multiple key milestones.\"\n\"Relapsed or refractory KMT2Ar acute leukemia patients have a particularly poor prognosis, and no drugs are approved for this difficult to treat disease,\" said Eytan M. Stein, M.D., Chief, Program for Drug Development in Leukemia, Department of Medicine at Memorial Sloan Kettering Cancer Center and Principal Investigator in the AUGMENT-101 tria...