Pivekimab Sunirine: First Approval.

Pivekimab sunirine (pivekimab sunirine-pvzy; DECNUPAZ™) is first-in-class CD123-directed antibody-drug conjugate (ADC) developed by ImmunoGen for the treatment of haematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukaemia (AML). CD123 is an attractive therapeutic target because it is highly expressed on malignant cells and leukaemic stem cells, but has limited expression on normal haematopoietic stem cells. On 27 May 2026, pivekimab sunirine received its first approval in the USA for the treatment of adult patients with BPDCN. This article summarizes the milestones in the development of pivekimab sunirine leading to this first approval.