The U.S. Food and Drug Administration (FDA) has granted INCB40093 Orphan Drug Designation (ODD) for the treatment of Hodgkin lymphoma (HL).  INCB4009 is a potent small molecule PI3Kδ inhibitor being developed by Incyte Inc., a biopharmaceutical company headquartered in Wilmington, DE.  PI3Kδ plays an essential role in promoting B-cell survival and excessive activation of PI3Kδ is associated with HL. HL is an uncommon lymphoma with a bimodal incidence curve.  Although HL has remained a largely curable disease, approximately 20% of patients will not be cured with currently available therapy and will require subsequent treatments.


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