NORTH CHICAGO, Ill., May 27, 2026
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved DECNUPAZ™ (pivekimab sunirine-pvzy) for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and highly aggressive blood cancer with limited treatment options. The approval marks a major milestone for AbbVie’s oncology portfolio, as DECNUPAZ becomes the company’s first antibody-drug conjugate (ADC) approved for a blood cancer indication.
DECNUPAZ Becomes First Outpatient ADC for BPDCN
DECNUPAZ is the first and only CD123-targeting ADC approved for BPDCN that can be initiated in an outpatient setting, potentially reducing treatment burden for patients battling the fast-progressing disease. BPDCN is a rare hematologic malignancy that commonly presents with skin lesions before rapidly spreading to the bone marrow, lymph nodes, and central nervous system. The disease primarily affects older adults, especially men between the ages of 60 and 70.
The FDA approval was supported by results from the Phase 1/2 CADENZA clinical trial, which evaluated the safety and efficacy of DECNUPAZ in patients with newly diagnosed as well as relapsed or refractory BPDCN. According to trial data, newly diagnosed patients treated with DECNUPAZ achieved a composite complete response rate of 69.7%, while the median duration of response reached 9.7 months. Importantly, nearly 40% of frontline patients were able to proceed to stem cell transplantation following treatment.
Among patients with relapsed or refractory disease, DECNUPAZ delivered a 15.7% composite complete response rate with a median duration of response of 9.2 months. Several patients in this group were also able to receive stem cell transplants after therapy, highlighting the drug’s potential role as a bridge-to-transplant treatment option.
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AbbVie Expands Oncology Leadership With ADC Innovation
AbbVie executives described the approval as a critical advancement for patients with difficult-to-treat cancers. The therapy targets CD123, a protein overexpressed in BPDCN cells, allowing the ADC to selectively deliver a potent DNA-damaging payload directly into cancer cells. The payload belongs to the indolinobenzodiazepine pseudodimer class, which induces cancer cell death through DNA alkylation and apoptosis.
“For patients living with rare cancers, progress in research can be life-changing,” said Roopal Thakkar, executive vice president, research and development, and chief scientific officer at 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.”
Clinical experts also emphasized the importance of the approval in addressing a major unmet medical need. Naveen Pemmaraju, M.D., professor of leukemia at The University of Texas MD Anderson Cancer Center, stated that BPDCN patients historically faced very limited therapeutic options, especially after relapse. He noted that the outpatient administration capability of DECNUPAZ could provide meaningful flexibility and accessibility for eligible patients.
Safety Profile and Commercial Significance
While the approval represents a breakthrough for BPDCN treatment, the therapy also carries significant safety considerations. DECNUPAZ includes a boxed warning for hepatotoxicity and hepatic veno-occlusive disease, which can be severe or fatal. Additional warnings include infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity.
The most common adverse reactions reported during clinical studies included edema, fatigue, musculoskeletal pain, hemorrhage, nausea, diarrhea, and infusion-related reactions. Laboratory abnormalities frequently observed included decreased white blood cell counts, platelet reductions, anemia, and elevated blood sugar levels.
The approval significantly strengthens AbbVie’s growing oncology business and further expands the competitive landscape in the rapidly evolving ADC market, one of the most active segments in biopharma. Analysts expect the approval to enhance AbbVie’s hematologic cancer portfolio while increasing industry focus on targeted therapies for ultra-rare malignancies.
With more than 35 investigational oncology programs currently in development, AbbVie continues to expand its pipeline across blood cancers and solid tumors using technologies including ADCs, immuno-oncology therapies, multispecific antibodies, and CAR-T platforms.
Source: AbbVie press release
