FDA OKs Decnupaz for Adults With Blastic Plasmacytoid Dendritic Cell Neoplasm

The FDA has approved Decnupaz (pivekimab sunirine-pvzy) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare hematologic malignancy, based on findings from the CADENZA clinical trial.

The approval, announced on May 27, 2026, applies to adult patients with treatment-naïve BPDCN as well as those with relapsed or refractory disease. Decnupaz is a CD123-directed antibody and alkylating agent conjugate designed to target BPDCN cells. According to the FDA, the approval was supported by complete remission and clinical complete remission rates observed in patients enrolled in the multicenter trial.

BPDCN is a rare blood cancer, and the FDA noted that Decnupaz received both breakthrough therapy designation and orphan drug designation during development. The application was also granted priority review.

Main Data That Support the Findings

The FDA evaluated efficacy data from the CADENZA trial, a multicenter, open-label, single-arm study that enrolled adults with BPDCN who did not have active central nervous system disease.

The trial included 33 patients with treatment-naïve BPDCN and 51 patients with relapsed or refractory BPDCN. Researchers evaluated efficacy based on the rate of complete remission or clinical complete remission, also referred to as CR/CRc.

Among patients with treatment-naïve BPDCN, 23 of 33 patients achieved a CR/CRc, resulting in a response rate of 69.7%. The median follow-up for these patients was 21.5 months.

The median duration of CR/CRc in the treatment-naïve group was 9.7 months.

In the relapsed or refractory BPDCN group, 8 of 51 patients achieved a CR/CRc, resulting in a response rate of 15.7%. The median follow-up for these patients was 24.1 months.

The median duration of CR/CRc among patients with relapsed or refractory disease was 9.2 months, with a range of 2.7 to 27.6+ months.

The FDA stated that the approval was based on these remission findings from the CADENZA study.

Trial details

CADENZA was conducted as a multicenter, open-label, single-arm clinical trial. The study enrolled adult patients with either newly diagnosed treatment-naïve BPDCN or relapsed or refractory BPDCN.

Patients enrolled in the trial could not have evidence of active central nervous system disease.

According to the FDA, the recommended dose of Decnupaz is 0.045 mg/kg administered intravenously over approximately 15 to 30 minutes once every three weeks in a 21-day cycle. Treatment is continued until disease progression or unacceptable toxicity.

The FDA noted that the dose should be calculated using the patient’s actual body weight.

Safety

The prescribing information for Decnupaz includes a Boxed Warning for hepatotoxicity, including hepatic veno-occlusive disease.

Additional warnings and precautions include infusion-related reactions, edema, sulfite allergic reactions and embryo-fetal toxicity.

The FDA announcement did not provide detailed rates of side effects observed during the CADENZA trial. However, the agency highlighted the safety risks included in the prescribing information as part of the approval announcement.

References

1. “FDA approves Decnupaz for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy” News Release. FDA, May 27, 2026

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