The U.S. FDA Approves Pivekimab Sunirine-pvzy for BPDCN

On May 27, 2026, the U.S. Food and Drug Administration (FDA) approved pivekimab sunirine-pvzy (Decnupaz, AbbVie) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). BPDCN is a rare and aggressive blood cancer.

The approval was based on results from the CADENZA clinical trial, which studied the treatment in people with newly diagnosed as well as relapsed or refractory BPDCN. Researchers found that some patients experienced complete remission after treatment with pivekimab sunirine-pvzy.

BPDCN is a rare blood cancer that can affect the skin, bone marrow, blood, and lymph nodes. Because the disease is uncommon and can progress quickly, new treatment options are important for people living with BPDCN.

"Pivekimab sunirine-pvzy is the first and only CD123 targeting ADC that can be initiated in an outpatient setting, offering a meaningful benefit for BPDCN patients in need of new treatment alternatives," said Dr. Naveen Pemmaraju, M.D., professor of leukemia, The University of Texas MD Anderson Cancer Center.

How does pivekimab sunirine-pvzy treat BPDCN?

Pivekimab sunirine-pvzy is an antibody drug conjugate (ADC). It is a combination of a CD123-directed antibody and an alkylating agent. The treatment targets CD123. This protein is commonly found on BPDCN cells, helping deliver treatment directly to the cancer.

The treatment is given as an IV infusion every few weeks.

The study that led to pivekimab sunirine-pvzy approval

The CADENZA clinical trial was a phase 1/2 trial. It included adults with either newly diagnosed or relapsed or refractory BPDCN with CD123 positivity.

Among patients with newly diagnosed BPDCN, nearly 70% achieved a complete remission or clinical complete remission. In patients with relapsed or refractory disease, about 16% achieved complete remission or clinical complete remission.

The FDA granted the treatment priority review, breakthrough therapy designation, and orphan drug designation to help speed treatment development for this rare cancer.

What are the common side effects of pivekimab sunirine-pvzy?

The prescribing information for pivekimab sunirine-pvzy includes a boxed warning for severe liver problems called hepatotoxicity. 

Other warnings and precautions include:

• Infusion-related reactions
• Edema (swelling)
• Sulfite allergic reactions
• Harm to a fetus (unborn baby)

During clinical studies, 13% patients stopped treatment due to side effects. The most common side effects were edema, fatigue, infusion-related reaction, nausea, and hypokalemia (low potassium). 

Next steps for people living with BPDCN

If you or a loved one has BPDCN, ask your healthcare team about whether pivekimab sunirine-pvzy may be a good treatment option for you. You can also ask whether clinical trials or care from a BPDCN specialist may help support your treatment plan.

Questions to ask your care team about pivekimab sunirine-pvzy

Consider asking your care team the following questions about pivekimab sunirine-pvzy:

• Is this treatment an option for my type of BPDCN?
• What side effects should I watch for during treatment?
• How often will I need infusions and monitoring?
• What testing will I need before or during treatment?
• Are there clinical trials available for BPDCN?

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Sources: 

• FDA approves pivekimab sunirine-pvzy for BPDCN
• AbbVie Press Release