AbbVie has received U.S. FDA approval for Decnupaz (pivekimab sunirine‑pvzy), an antibody‑drug conjugate targeting CD123 for adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra‑rare and aggressive blood cancer.
This is the first antibody‑drug conjugate approved for BPDCN and AbbVie’s first ADC approval in a blood cancer indication.
Decnupaz originated from the ImmunoGen portfolio; AbbVie acquired ImmunoGen in 2024 for about $10.1 billion, and this approval is the first ADC from that deal to gain U.S. marketing authorization.
The approval is supported by data from the global phase 1/2 CADENZA trial, which showed a composite complete response rate near 70% in newly diagnosed BPDCN patients and differentiated the drug as the first ADC for BPDCN that can be initiated in an outpatient setting.
Clinically, Decnupaz offers a new treatment option for a patient population with very limited therapies and high unmet need, cementing AbbVie’s expanding presence in the ADC oncology space.
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