MAY 27 2026
AbbVie — pivekimab sunirine $ABBV
for relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN)
About
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare blood cancer in which immune cells called plasmacytoid dendritic cells grow out of control, often showing up in the skin and bone marrow and crowding out healthy blood cells. Pivekimab sunirine is an antibody-drug conjugate: a lab-made antibody that seeks out CD123, a protein on these cancer cells, and delivers a chemotherapy payload directly to them. Because BPDCN cells carry CD123, this targeted delivery may kill the cancerous cells while limiting damage to healthy tissue.
Pivotal trial
This phase I trial finds the best dose of PVEK when given together with fludarabine, cytarabine, granulocyte colony-stimulating factor (G-CSF), and idarubicin, (FLAG-Ida) regimen and studies the effectiveness of this combination therapy in treating patients with newly diagnosed adverse risk acute myeloid leukemia (AML) and other high-grade myeloid neoplasms. PVEK is a monoclonal antibody linked to a chemotherapy drug
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on pivekimab sunirine
- AbbVie Targets Pediatric AML With New Pivekimab Sunirine Trial, Signaling Deeper Oncology Push - TipRanks
- FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm - The Cancer Letter
- BPDCN: Pivekimab sunirine-pvzy gains FDA approval with high frontline CR/CRc but safety caveats - Vera Health
- FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm - The Cancer Letter
- FDA Approves Pivekimab Sunirine for BPDCN - Targeted Oncology