Syndax granted Priority Review for NDA for revumenib by FDA

Syndax Pharmaceuticals announced that the FDA has granted Priority Review for its New Drug Application, or NDA, for revumenib, the Company’s first-in-class menin inhibitor, for the treatment of adult and pediatric relapsed or refractory, or R/R, KMT2A-rearranged, or KMT2Ar, acute leukemia. The NDA filing is being reviewed under the FDA’s Real-Time Oncology Review Program, or RTOR, and has been assigned a Prescription Drug User Fee Act, or PDUFA, target action date of September 26, 2024. RTOR allows for a more efficient review and close engagement between the sponsor and the FDA throughout the submission process, which historically has led to earlier approvals. The NDA submission is supported by positive data from the pivotal AUGMENT-101 trial of revumenib in adult and pediatric patients with KMT2Ar acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL). As previously reported, the trial met its primary endpoint at the protocol-defined interim analysis with a complete remission, or CR, or a CR with partial hematological recovery, or CRh, rate of 23% among the 57 efficacy evaluable patients in the pooled KMT2Ar acute leukemia population. 70% of patients who achieved a CR/CRh and were assessed for minimal residual disease, or MRD, were MRD negative.