Syndax Gets FDA Breakthrough Designation for Revumenib in KMT2Ar Leukemia

By Colin Kellaher

Syndax Pharmaceuticals Inc. on Monday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to its revumenib drug candidate for the treatment of certain leukemia patients.

The Waltham, Mass., clinical-stage biopharmaceutical company said the designation covers revumenib for adults and children with relapsed or refractory acute leukemia harboring a KMT2A rearrangement, or KMT2Ar.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Syndax said revumenib has the potential to be the first FDA-approved drug to address KMT2Ar leukemia, which is believed to occur in up to 10% of all acute leukemias, including in roughly 80% of infant acute leukemias.

Syndax said it is on track to file for FDA approval of revumenib by the end of next year, with the potential for an expedited approval with a broad indication.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

December 05, 2022 07:57 ET (12:57 GMT)

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