Policy & Regulation
Syndax Pharmaceuticals' revumenib receives US FDA's Breakthrough Therapy Designation
6 December 2022 -

Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a US-based clinical-stage biopharmaceutical company, announced on Monday that it has received Breakthrough Therapy Designation (BTD) from the United States Food and Drug Administration (FDA) for its revumenib to treat adult and paediatric patients with relapsed or refractory (R/R) acute leukaemia harbouring a KMT2A rearrangement (KMT2Ar).

The product is the firm's highly selective, oral menin inhibitor. The company has received the BTD based on the Phase one data from the AUGMENT-101 trial.

Michael A Metzger, Syndax chief executive officer, said, 'The Breakthrough Therapy Designation underscores revumenib's potential as a first- and best-in-class therapy to meaningfully change the treatment paradigm for patients with R/R KMT2Ar acute leukaemia, whether it presents clinically as acute myeloid leukaemia (AML) or acute lymphocytic leukaemia (ALL), in adults or children. Revumenib has the potential, if approved, to be the first drug to address the significant unmet need in KMT2Ar leukaemia believed to occur in up to 10% of all acute leukaemias, including in approximately 80% of infant acute leukaemias. Syndax is committed to bringing revumenib to these patients as quickly as possible and we look forward to working collaboratively with the FDA to expedite a potential approval of revumenib.'