US-based clinical stage biopharmaceutical company Syndax Pharmaceuticals (Nasdaq: SNDX) announced on Monday that the Prescription Drug User Fee Act (PDUFA) action date for revumenib's New Drug Application (NDA) has been extended by the US Food and Drug Administration (FDA).

Revumenib is intended for the treatment of adults and paediatric patients with relapsed or refractory (R/R) KMT2Ar acute leukaemia.

The FDA notified Syndax on 26 July 2024 that the company required additional time to conduct a full review of supplemental information provided to the FDA in response to its 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 26 September 2024. No additional trials or manufacturing information have been requested by the FDA.

Michael A Metzger, Syndax chief executive officer, said, 'Revumenib, upon approval, will be the first drug indicated to treat patients with KMT2A-rearranged acute leukaemia, a population with significant unmet need. We are confident that the data from the AUGMENT-101 trial, as well as the additional information provided to the FDA, support approval and continue to demonstrate the meaningful benefit revumenib brings to patients with this devastating disease. We look forward to continuing our engagement with the FDA as they complete their review of the NDA by 26 December 2024.'