Syndax: FDA grants Breakthrough Therapy Designation for revumenib

Syndax Pharmaceuticals announced that the U.S. FDA has granted Breakthrough Therapy Designation for revumenib for the treatment of adult and pediatric patients with relapsed or refractory acute leukemia harboring a KMT2A rearrangement. Revumenib is the company’s highly selective, oral menin inhibitor. The company remains on track to submit an NDA for revumenib by the end of 2023 with the potential for an expedited approval with a broad indication.