On May 27, 2026, the US Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Efficacy and Safety

Efficacy was evaluated in CADENZA (NCT03386513), a multicentre, open-label, single-arm clinical trial that included adult patients with treatment-naïve BPDCN (N=33) or relapsed or refractory BPDCN (N=51), without evidence of active central nervous system disease. Efficacy was based on the rate of complete remission or clinical complete remission (CR/CRc).

In patients with treatment-naïve BPDCN (N = 33), 23 patients (69.7%; 95% CI: 51.3, 84.4) achieved a CR/CRc with a median follow-up of 21.5 months. The median duration of CR/CRc was 9.7 months (95% CI: 2.9, not estimable). In patients with relapsed or refractory BPDCN (N = 51), 8 patients (15.7%; 95% CI: 7.0, 28.6) achieved a CR/CRc with a median follow-up of 24.1 months. The median duration of CR/CRc was 9.2 months (Range: 2.7, 27.6+).

The prescribing information includes a Boxed Warning for hepatotoxicity, including hepatic veno-occlusive disease, and warnings and precautions for infusion-related reactions, edema, sulfite allergic reactions, and embryo-foetal toxicity.

Recommended Dosage

The recommended pivekimab sunirine-pvzy dose is 0.045 mg/kg intravenously over approximately 15-30 minutes once every three weeks (21-day cycle) until disease progression or unacceptable toxicity. The dose should be calculated based on the patient’s actual body weight.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review. Pivekimab sunirine-pvzy received breakthrough designation and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Source: FDA