The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Syndax Pharmaceuticals for the treatment of relapsed/refractory acute leukemia with either MLLr or NPM1 mutations called SNDX-5613. Previously, SNDX-5613 was granted Orphan Drug Designation to treat patients diagnosed with acute myeloid leukemia (AML). Dr. Briggs W. Morrison, CEO of Syndax, stated, “Genetically-defined acute leukemias represent an underserved area marked by particularly poor prognosis and limited therapeutic options. As we move toward initiating our pivotal study, receipt of FTD from the FDA underscores SNDX-5613’s potential to meaningfully improve outcomes for patients with MLLr and NPM1 mutant acute leukemias.”
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