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 and aggressive blood cancer that originates from abnormal immune cells called plasmacytoid dendritic cells. Pivekimab sunirine is an antibody-drug conjugate that targets CD123, a protein often found on cancerous cells, delivering a chemotherapy payload directly to them. By homing in on CD123-positive cells, this approach may reduce damage to healthy tissues while potentially improving outcomes for patients with relapsed or refractory BPDCN.
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
- FDA Approves Pivekimab Sunirine for BPDCN - Oncology News Central
- FDA Approves Pivekimab Sunirine for BPDCN - Targeted Oncology
- FDA Approves Decnupaz (pivekimab sunirine-pvzy), the First ADC for Adults With BPDCN - Oncodaily
- FDA Approved Pivekimab Sunirine‑Pvzy for Adult Patients – BPDCN International Registry - Oncodaily
- Raffaele Colombo: FDA Approves Pivekimab Sunirine Based on CADENZA Trial - Oncodaily