AbbVie received U.S. FDA clearance for Decnupaz (pivekimab sunirine), a CD123-targeting antibody-drug conjugate for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The approval follows the company’s 2023 buyout of ImmunoGen, which contributed the asset to AbbVie’s oncology portfolio. Regulatory approval in ultra-rare cancers can reshape competitive positioning in targeted hematologic oncology, especially where limited treatment options exist. The clearance is backed by clinical data from the global Cadenza study. The decision extends momentum for AbbVie’s ADC strategy and adds another potential revenue stream beyond AbbVie’s core immunology and oncology businesses.