The FDA has approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a first-in-class CD123-directed antibody and alkylating agent conjugate, for the treatment of adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The approval, which followed breakthrough designation, orphan drug designation, and priority review, was based on efficacy demonstrated in the open-label, single-arm CADENZA trial of patients with BPDCN — an ultra-rare and aggressive hematologic malignancy.