Syndax Pharmaceuticals 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. 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 (BTD) for the same indication and recent positive topline data from the AUGMENT-101 pivotal trial in R/R KMT2Ar acute leukemia.

Specifically, it allows for close engagement between the sponsor and the FDA throughout the submission process and it enables the FDA to review individual sections of modules of a drug application rather than requiring the submission of complete modules or a complete application prior to initiating review. From the start of the program in 2018, 22 original applications (including sNDAs and NDAs) have been reviewed under the RTOR Program, resulting in 19 U.S. drug approvals while 3 are still being reviewed. Revumenib was granted Orphan Drug Designation by the FDA and European Commission for the treatment of patients with AML, and Fast Track designation by the FDA for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation.

Revumenib was granted BTD by the FDA for the treatmentof adult and pediatric patients withR/R acute leukemia harboring a K MT2A rearrangement. Syndax plans to initiate the NDA submission for KMT2Ar acute leukemiaunder the Oncology Center of excellence Review RTOR Program imminently and expects to complete the submission by year-end 2023. Following the receipt of Breakthrough Therapy designation from the FDA for revumenib for the treatment of R/R acute leukemia harboring an KMT2A rearrangements, regardless of age or tumor type, and based on discussions with the FDA, the Company decided to pool data from the AUGMENT - cohorts enrolling R/R KMT2 Ar AML and R/R KMT2AR ALL.