Decnupaz is a CD123-directed antibody-drug conjugate (ADC) approved for adults with BPDCN, making it the first ADC for the disease that can be initiated in an outpatient setting.
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare and aggressive blood cancer that can be difficult to recognize early and is often associated with relapse after treatment.
On May 27, 2026, the FDA approved AbbVie’s Decnupaz (pivekimab sunirine-pvzy) for adults with BPDCN, adding a new targeted treatment option for a disease with limited therapies.
Decnupaz is a CD123-directed antibody-drug conjugate (ADC). Decnupaz is the first ADC approved for BPDCN that can be initiated in an outpatient setting, and AbbVie’s first ADC approved for a blood cancer.
BPDCN is more common in men and often affects older adults. Historically, treatment has included intensive chemotherapy regimens adapted from other blood cancers, CD123-directed therapy and, for eligible patients, stem cell transplant.
The disease has been difficult to treat, with published studies reporting a median survival of about one to two years after diagnosis.
BPDCN often first appears in the skin. Patients may develop brown or purple bruise-like spots, plaques or nodules, which can make the disease difficult to distinguish from other skin conditions.
Although BPDCN can sometimes be detected only in the skin, it can spread quickly to the bone marrow, lymph nodes, blood and central nervous system.
Diagnosis usually requires biopsy and specialized laboratory testing because symptoms are not specific.
Decnupaz targets CD123, also known as IL-3Rα, a protein overexpressed in BPDCN. The ADC is designed to bind to CD123-positive cancer cells and deliver an alkylating payload that damages DNA, leading to cancer cell death.
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Decnupaz’s FDA approval was supported by CADENZA, a Phase I/II, multicenter, open-label, single-arm trial. The study evaluated Decnupaz in adults with previously untreated BPDCN and in adults with relapsed or refractory BPDCN. Patients included in the efficacy analysis had no evidence of active central nervous system disease.
The FDA’s efficacy assessment was based on complete remission or clinical complete remission, which are measures used to assess deep responses to therapy in BPDCN.
Among 33 previously untreated BPDCN patients, 23 patients (69.7%) achieved complete remission or clinical complete remission after a median follow-up of 21.5 months. The median duration of response was 9.7 months.
Responses were lower in patients whose disease had returned or had not responded to earlier treatment. In this relapsed or refractory group, eight of 51 patients (15.7%) achieved complete remission or clinical complete remission after a median follow-up of 24.1 months. The median duration of response was 9.2 months.
Some patients also went on to receive a stem cell transplant after Decnupaz treatment, including 13 patients (39.4%) in the previously untreated group and six patients (11.8%) in the relapsed or refractory group.
Decnupaz carries a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease, a serious condition involving blocked blood flow in the liver.
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Decnupaz joins Elzonris (tagraxofusp-erzs), the earlier CD123-targeted treatment approved for adults and children two years and older with BPDCN.
Both treatments target CD123, but they work in different ways. Decnupaz uses a CD123-targeting antibody to find BPDCN cells and deliver a DNA-damaging drug payload. Elzonris is a fusion protein that uses recombinant human interleukin-3 to bind CD123-positive cells and deliver a truncated diphtheria toxin.
In the rare or difficult-to-treat blood cancer space, the FDA recently granted accelerated approval to BeOne Medicines’ Beqalzi (sonrotoclax) for adults with mantle cell lymphoma whose cancer has come back or stopped responding after at least two earlier treatments, including a BTK inhibitor.
FAQs
What does “outpatient setting” mean for Decnupaz?
It means Decnupaz can be started without requiring a planned hospital admission, although patients still receive the drug by IV and need medical monitoring.
What does “median duration of response” mean?
It refers to the midpoint for how long patients’ responses to treatment lasted.
Why is CD123 important in BPDCN?
CD123 is a protein found at high levels on BPDCN cells. Decnupaz uses this target to help deliver a DNA-damaging drug payload to cancer cells.
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