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StackHealth / FDA clears pivekimab sunirine (Decnupaz) as first BPDCN ADC

FDA Approves Decnupaz (pivekimab sunirine-pvzy), the First ADC for Adults With BPDCN

oncodaily - On May 27, 2026, the U.S. FDA granted approval to pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for the treatment of adults with blastic plasmacytoid […]

AI Summary: The FDA approved pivekimab sunirine (Decnupaz/pvzy), the first antibody‑drug conjugate for blastic plasmacytoid dendritic cell neoplasm (BPDCN), marking a regulatory win for an ultra‑rare blood cancer. The decision underscores ADCs’ growing role in niche hematologic malignancies and anchors AbbVie’s expanding ADC strategy.

#pharmaceuticals #biotech #drugdevelopment #fda #oncology #cancerresearch #clinicaltrials

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