FDA Clears Decnupaz (pivekimab sunirine) for Adults With BPDCN | iPharmaCenter
- Badari Andukuri
- May 28
- 2 min read
Decnupaz (pivekimab sunirine) has received U.S. FDA approval for use in adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a very rare and aggressive blood cancer with few effective therapies available. This medicine is an antibody-drug conjugate (ADC) and is notable because treatment can be started in the outpatient setting rather than requiring admission to the hospital. It also represents AbbVie’s first ADC approved in the hematology/oncology space.
BPDCN often first shows up as skin lesions and can quickly involve the bone marrow, lymph nodes, and the central nervous system. The disease mainly affects older adults, particularly men in their 60s and 70s. Even with intensive chemotherapy and, in some cases, stem cell transplantation, many patients relapse, highlighting the strong need for newer, more effective options such as Decnupaz.
Decnupaz was evaluated in the global Phase 1/2 CADENZA study, which investigated its safety and effectiveness in people with BPDCN. In newly diagnosed adults with BPDCN who received Decnupaz (33 patients), the composite complete response rate was about 69.7 percent, with responses lasting a median of roughly 9.7 months. Around 39 percent of these newly diagnosed patients were able to proceed to a stem cell transplant after treatment on the study. Among 51 patients whose disease had come back or was resistant to prior therapy, the composite complete response rate was about 15.7 percent, with responses lasting around 9.2 months on average, and nearly 11.8 percent moved on to stem cell transplantation.
The CADENZA trial was a Phase 1/2, multicenter, open-label study enrolling patients with CD123-positive blood cancers, including BPDCN, to better understand how pivekimab sunirine behaves in the body and how well it works. Investigators assessed safety, tolerability, pharmacokinetics, immunogenicity, and anti-leukemia activity, and used these data to identify an appropriate dose and schedule for monotherapy treatment.
A published analysis described 84 patients: 33 adults received Decnupaz as first-line therapy without central nervous system disease, while 51 had relapsed or refractory BPDCN without active CNS involvement; a subset of frontline patients also had other cancers, making their management more complex.
What is the mechanism of action of Decnupaz (pivekimab sunirine)?
Decnupaz (pivekimab sunirine) is an ADC directed against CD123, a protein commonly overexpressed on BPDCN cells, making it a rational therapeutic target. ADCs work by linking a targeted antibody to a highly potent cytotoxic payload, allowing the drug to bring this payload directly to cancer cells that express the target. In Decnupaz, the payload belongs to the indolinobenzodiazepine pseudodimer class, which binds to DNA, causes single-strand breaks without crosslinking, and triggers apoptosis, ultimately leading to death of the malignant cells.
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