FDA Approves Decnupaz (Pivekimab Sunirine) for Rare Blood Cancer BPDCN — 15th Oncology Approval of 2026

On May 27, 2026, the FDA approved pivekimab sunirine-pvzy (Decnupaz), a CD123-directed antibody-alkylating agent conjugate, for adults and pediatric patients aged 2 years and older with blastic plasmacytoid dendritic cell neoplasm (BPDCN). BPDCN is a rare, highly aggressive hematologic malignancy arising from plasmacytoid dendritic cell precursors, historically carrying a median survival under 2 years without stem cell transplantation. Decnupaz targets CD123 (IL-3 receptor alpha), which is nearly universally overexpressed on BPDCN cells, and delivers a cytotoxic alkylating payload directly to malignant cells. The approval is based on a pivotal Phase 1/2 trial demonstrating complete response rates in treatment-naive patients with median duration of response exceeding 14 months in complete responders. This marks the 15th FDA oncology approval in 2026 and follows the first BPDCN-targeted drug approval — tagraxofusp (Elzonris) in 2018 — offering oncologists an alternative CD123-targeted mechanism. BPDCN affects approximately 500–1,000 patients per year in the United States and historically had limited treatment options beyond aggressive chemotherapy and allogeneic stem cell transplant. The accelerated approval pathway was used based on overall response rate, with confirmatory overall survival data pending.