pivekimab sunirine — Drug Monograph
Brand names: DECNUPAZ
Drug class: Antibody-Drug Conjugate
Mechanism of Action
Anti-CD123 (IL-3 receptor alpha chain) humanized monoclonal antibody conjugated to SG3249, a highly potent pyrrolobenzodiazepine (PBD) dimer payload, via a protease-cleavable linker. CD123 is markedly overexpressed on blastic plasmacytoid dendritic cell neoplasm (BPDCN) tumor cells and normal plasmacytoid dendritic cells. After internalization, SG3249 cross-links DNA in the minor groove causing irreversible double-strand DNA breaks and apoptosis in CD123-positive cells.
FDA Indications
- Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults (FDA accelerated approval May 2026)
Common Side Effects
- Peripheral edema
- Pleural effusion
- Neutropenia
- Thrombocytopenia
- Anemia
- Fatigue
- Nausea
- Elevated liver enzymes (GGT)
Clinical Pearl
BPDCN is an exceptionally rare and aggressive hematologic malignancy (<1,000 cases/year in the US) with poor prognosis and historically no standard of care beyond tagraxofusp (SL-401, a CD123-directed cytotoxin fusion protein approved in 2018). Pivekimab-sunirine offers a true ADC-based approach targeting the same CD123 antigen. The PBD dimer payload class (shared with loncastuximab-tesirine) mandates vigilance for effusions and the same corticosteroid prophylaxis strategy. BPDCN commonly…
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