Morningstar

Syndax Wins FDA Approval for Leukemia Treatment

Provided by Dow Jones

By Kelly Cloonan 




  Syndax has received approval from the Food and Drug Administration for a treatment for a type of acute leukemia. 



  The biopharmaceutical company said Friday the approval is for its Revuforj therapy to treat relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation in patients who have no satisfactory alternative treatment options. 



  The approval is based on data from a Phase 2 trial that showed a 23% rate of complete remission. 



  Acute myeloid leukemia is a blood and bone marrow cancer marked by rapid disease progression, the company said. Mutations in the NPM1 gene occur in about 30% of adults with the disease and can help develop an aggressive blood cancer associated with high rates of relapse. 



  Revuforj also received FDA approval last year to treat acute leukemia with a KMT2A translocation. 





  Write to Kelly Cloonan at kelly.cloonan@wsj.com 





  (END) Dow Jones Newswires



  October 24, 2025 15:40 ET (19:40 GMT)


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