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 often involves the skin, bone marrow, and other organs. Pivekimab sunirine is an antibody-drug conjugate that delivers a chemotherapy agent directly to cancer cells by targeting the CD123 protein on their surface. This targeted delivery could potentially attack the cancer while sparing healthy tissues, offering a new approach for patients with this difficult-to-treat disease.
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
- BPDCN: Pivekimab sunirine-pvzy gains FDA approval with high frontline CR/CRc but safety caveats - Vera Health
- FDA Approves Pivekimab Sunirine for BPDCN - Targeted Oncology
- FDA Approves Pivekimab Sunirine for BPDCN - Oncology News Central
- FDA Approved Pivekimab Sunirine‑Pvzy for Adult Patients – BPDCN International Registry - Oncodaily
- FDA Approves Pivekimab Sunirine in Rare Hematologic Malignancy - CancerNetwork