Sumitomo Pharma announces that DSP-5336 has received FDA Fast Track Designation for the treatment of relapsed or refractory acute myeloid leukemia (AML) with a KMT2A rearrangement, also known as, mixed lineage leukemia rearrangement (MLLr) or nucleophosmin mutation (NPM1m). Menin serves as a tumor suppressor in endocrine glands. Novel menin inhibitors are novel targeted agents in clinical studies targeting genetically defined subsets of acute leukemia.
DSP-5336 is an investigational menin-MLL interaction inhibitor. DSP-5336 has been granted Orphan Drug Designation in acute myeloid leukemia, and Fast Track Designation in relapsed or refractory acute myeloid leukemia with MLLr or NPM1m.
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