U.S. FDA Approves DECNUPAZ™ (pivekimab sunirine-pvzy) for Treatment of Adult Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm, an Ultra-Rare and Aggressive Blood Cancer With Limited Treatment Options

- DECNUPAZ is the first and only antibody-drug conjugate (ADC) approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN) that is initiated in an outpatient setting
- DECNUPAZ marks AbbVie's first ADC approved for blood cancer

NORTH CHICAGO, Ill., May 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved DECNUPAZ^TM (pivekimab sunirine-pvzy) for the treatment of adult patients with BPDCN, an ultra-rare and aggressive hematologic malignancy with limited treatment options. The approval is supported by data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of DECNUPAZ for BPDCN.

"For patients living with rare cancers, progress in research can be life‑changing," said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie. "This approval delivers a new option for treating BPDCN and demonstrates our determination to drive meaningful advancements for patients affected by difficult-to-treat cancers."

Patients with BPDCN often present with skin lesions, and the disease can rapidly spread to the bone marrow, lymph nodes, and central nervous system. The disease typically affects adult men aged 60-70 years. Despite initial treatment with intensive chemotherapy, which may include stem cell transplantation, many patients experience relapse, underscoring the need for new treatment options.¹

"BPDCN is an aggressive disease with historically limited therapeutic options, particularly for patients whose disease has relapsed or become refractory," said Naveen Pemmaraju, M.D., professor of leukemia, The University of Texas MD Anderson Cancer Center. "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."

In the Phase 1/2 CADENZA trial, newly diagnosed patients with BPDCN who were treated with DECNUPAZ demonstrated clinically meaningful and durable responses. In newly diagnosed patients with BPDCN (n=33), researchers observed a composite complete response rate of 69.7% with a median duration of response of 9.7 months, with 13 patients (39.4%) who were able to receive post-study treatment stem cell transplant. Patients with relapsed or refractory disease (n=51) had a composite complete response rate of 15.7% with median duration of response rate of 9.2 months, with six patients (11.8%) who were able to receive post-study treatment stem cell transplant.²

Most common adverse reactions (≥20%) were edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. DECNUPAZ has a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease, and warnings and precautions for infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity.

About the CADENZA Trial
CADENZA is a Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and anti-leukemia activity of pivekimab sunirine-pvzy in patients with CD123-positive hematologic malignancies, including BPDCN. The study was also designed to determine the maximum tolerated dose, recommended Phase 2 dose and dosing schedule for pivekimab sunirine-pvzy monotherapy.³ Results published in the Journal of Clinical Oncology included a total of 84 patients who were part of the trial. Of these, 33 patients with no CNS involvement received DECNUPAZ as a frontline treatment and 51 had relapsed or refractory disease without evidence of active CNS disease. Eleven patients in the frontline treatment group had prior or concurrent cancer diagnoses in addition to BPDCN, making their treatment more complex and challenging.²

About DECNUPAZ (pivekimab sunirine-pvzy)
DECNUPAZ (pivekimab sunirine-pvzy) is a CD123-targeting ADC for the treatment of adult patients diagnosed with the hematological malignancy BPDCN. ADCs are designed to deliver potent cell death-inducing agents called 'payloads' directly to the cells expressing a specific protein. CD123 (IL-3Rα) is a protein overexpressed in BPDCN, making it an ideal target for therapy. The payload is a member of the indolinobenzodiazepine pseudodimer class that alkylates DNA and causes single-strand DNA breaks without crosslinking, leading to apoptosis and cell death.⁴

In October 2020, the FDA granted pivekimab sunirine-pvzy Breakthrough Therapy Designation for relapsed/refractory BPDCN.

DECNUPAZ U.S. Uses and Important Safety Information, Including Boxed Warning⁴

Use
What is DECNUPAZ?
DECNUPAZ is a prescription medicine used to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

It is not known if DECNUPAZ is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about DECNUPAZ?
DECNUPAZ can cause serious side effects, including:

• Liver problems (hepatotoxicity), including veno-occlusive disease (blockage of the small veins in the liver), which can be severe, life-threatening, or may lead to death. Your healthcare provider will do blood tests before each dose of DECNUPAZ and during treatment with DECNUPAZ to check for liver problems. Tell your healthcare provider right away if you develop signs or symptoms of liver problems, including:

Your healthcare provider will check you for liver problems during your treatment with DECNUPAZ and may provide treatment for your side effects. Your healthcare provider may also delay or stop treatment with DECNUPAZ if you have severe liver problems.

What should I tell my healthcare provider before receiving DECNUPAZ?
Tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• are allergic to sulfites
• have asthma
• have kidney problems
• are pregnant or plan to become pregnant. DECNUPAZ can harm your unborn baby.

Females who are able to become pregnant:

• • Your healthcare provider will check for pregnancy before you start treatment with DECNUPAZ.
  • Use effective birth control (contraception) during treatment with DECNUPAZ and for 7 months after your last dose.
  • Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with DECNUPAZ.

Males who have female partners who are able to become pregnant:

• • Use an effective birth control during treatment with DECNUPAZ and for 4 months after your last dose of DECNUPAZ.
• are breastfeeding or plan to breastfeed. It is not known if DECNUPAZ passes into your breast milk. Do not breastfeed during treatment with DECNUPAZ and for 1 month after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect DECNUPAZ and increase your risk of side effects.

What are the possible side effects of DECNUPAZ?

DECNUPAZ can cause serious side effects, including:

• Liver problems (hepatotoxicity), including veno-occlusive disease (blockage of the small veins in the liver), which can be severe, life-threatening, or may lead to death. Your healthcare provider will do blood tests before each dose of DECNUPAZ and during treatment with DECNUPAZ to check for liver problems. Tell your healthcare provider right away if you develop signs or symptoms of liver problems, including yellowing of the skin or swelling of your stomach.
• Infusion-related reactions (IRR). DECNUPAZ can cause serious, life-threatening infusion related reactions. Your healthcare provider will give you medicines the day before and on the day of your infusion of DECNUPAZ to help reduce infusion-related reactions. Your healthcare provider will check you for symptoms of infusion related reactions during your infusion and for at least 4 hours or longer if needed, after your first infusion, and for at least 1 hour after each of your next infusions. Tell your healthcare provider right away if you develop signs or symptoms of infusion related reactions, including:

• Fluid retention (edema). DECNUPAZ can cause your body to hold too much fluid during treatment. Your healthcare provider may prescribe water pills (diuretic) if you develop edema. Tell your healthcare provider if you develop new or worsening edema, including:
  • swelling of your ankles or legs
  • shortness of breath or difficulty breathing
  • unusual weight gain
• Sulfite allergic reactions. DECNUPAZ contains sodium metabisulfite, a sulfite that may cause severe, life-threatening allergic reactions in some people. Sulfite allergic reactions are more common in people with asthma than in people without asthma. Get medical help right away if you develop hives; itching; rash; swelling of the eyes, tongue, or lips; chest pain; trouble breathing or swallowing.

The most common side effects include:

The most common severe abnormal laboratory test results with DECNUPAZ include:

Your healthcare provider may decrease your dose, delay your infusion, or permanently stop treatment with DECNUPAZ if you have side effects.

DECNUPAZ may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of DECNUPAZ. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including BOXED WARNING.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit

www.AbbVie.com/PatientAccessSupport to learn more.

About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.

Today, our expansive oncology portfolio is comprised of approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit us at http://www.abbvie.com/oncology.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

1. Shimony, S. et al. Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): 2025 Update on Diagnosis, Pathophysiology, Risk Assessment, and Management. American Journal of Hematology. Published June 17, 2025. Available at https://onlinelibrary.wiley.com/doi/10.1002/ajh.27737. Accessed April 15, 2026.
2. Pemmaraju, N. et al. Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). J Clin Oncol 44, 861-873(2026). Available at https://ascopubs.org/doi/10.1200/JCO-25-02083.  Accessed April 15, 2026.
3. Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN. Available at https://clinicaltrials.gov/study/NCT03386513. Accessed April 15, 2026.
4. DECNUPAZ. Summary of Product Characteristics. AbbVie.

SOURCE AbbVie