Syndax to submit NDA to FDA for revumenib

Syndax Pharmaceuticals announced that the company will submit a New Drug Application for revumenib in relapsed or refractory KMT2Ar acute leukemia, including acute myeloid leukemia and acute lymphoid leukemia, under the U.S. FDA Real-Time Oncology Review program. Revumenib is the company’s highly selective oral menin inhibitor. During 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 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.