FDA Approves Pivekimab Sunirine for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasms
Clinical Summary:
- Based on results from the phase 2 CADENZA trial, the FDA has approved pivekimab sunirine for adult patients with with blastic plasmacytoid dendritic cell neoplasms.
- In this multicenter, single-arm study, pivekimab sunirine demonstrated high complete remission rates with durable responses in both the treatment-naïve and relapsed/refractory settings.
- This approval provides a new targeted treatment option for patients with blastic plasmacytoid dendritic cell neoplasms, a rare and aggressive hematologic malignancy with historically limited therapeutic options.
On May 27, 2026, the US Food and Drug Administration (FDA) approved pivekimab sunirine (Decnupaz, AbbVie) for adult patients with blastic plasmacytoid dendritic cell neoplasms. This approval was based on results from the phase 3 CADENZA trial.
In this open-label, single-arm trial, 84 patients with either treatment-naïve (n = 33) or relapsed/refractory (n = 51) blastic plasmacytoid dendritic cell neoplasms without evidence of active central nervous system disease were enrolled to receive pivekimab sunirine. The primary end point was complete remission or clinical complete remission rate.
At analysis, complete remission or clinical complete remission was achieved in 69.7% of treatment-naïve patients and 15.7% of relapsed/refractory patients. The median duration of complete remission or clinical complete remission was 9.7 months and 9.2 months, respectively.
The recommended dose of pivekimab sunirine is 0.045 mg/kg administered intravenously once every 3 weeks for approximately 15 to 30 minutes in 21-day cycles until disease progression or unacceptable toxicity. Dosing should be calculated based on body weight.
The prescribing information includes a Boxed Warning for hepatotoxicities including hepatic veno-occlusive disease. Warnings and precautions for infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity are also included.
Source:
US Food and Drug Administration. FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy. Accessed on May 27, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare
