May 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Decnupaz (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.n 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.
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.
