AbbVie won FDA approval for its CD123-targeting antibody-drug conjugate Decnupaz (pivekimab sunirine) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), following the company’s 2023 purchase of ImmunoGen. The approval, based on data from the global Cadenza study, adds another ADC into a fast-growing ultra-rare hematology segment where durable responses are the central bar. In parallel, AbbVie’s ADC strategy continued to draw attention after another FDA clearance tied to an ImmunoGen-era pipeline. The BPDCN approval expands the company’s label footprint in a disease with limited treatment options and underscores the continued regulatory traction of CD123-directed conjugates.
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