Syndax announces PDUFA action date extension for revumenib NDA

Syndax announced that the FDA has extended the Prescription Drug User Fee Act – PDUFA – action date for the New Drug Application – NDA – for revumenib for the treatment of adults and pediatric patients with relapsed or refractory KMT2Ar acute leukemia. The FDA notified Syndax on July 26 that they required additional time to conduct a full review of supplemental information provided to the FDA in response to their requests. The submission of additional information to the FDA was determined to constitute a Major Amendment to the NDA and resulted in a standard three-month extension to the original PDUFA action date of September 26, 2024. No additional trials or manufacturing information have been requested by the FDA. The NDA for revumenib was granted Priority Review and is being reviewed under the FDA’s Real-Time Oncology Review program. The FDA previously granted Breakthrough Therapy, Fast Track and Orphan Drug designations for revumenib.