FDA Approves Pivekimab Sunirine in Rare Hematologic Malignancy

The FDA has approved pivekimab sunirine-pvzy (Decnupaz) as a treatment for adult patients with blastic plasmacytoid dendritic cell neoplasms (BPDCNs), according to a news release from the agency.¹

The agency based its approval on data from the single-arm phase 1/2 CADENZA trial (NCT03386513), which evaluated the agent in patients with BPDCN in the treatment-naive (n = 33) or relapsed/refractory setting (n = 51). Data in the treatment-naive cohort revealed a rate of complete remission (CR)/clinical complete remission (CRc) of 69.7% (95% CI, 51.3%-84.4%) after a median follow-up of 21.5 months, with a median duration of CR/CRc of 9.7 months (95% CI, 2.9-not estimable [NE]). Across the relapsed/refractory group, the CR/CRc rate was 15.7% (95% CI, 7.0%-28.6%) after a median follow-up of 24.1 months; the median duration of CR/CRc was 9.2 months (range, 2.7 to 27.6+).

The prescribing information for pivekimab sunirine includes a Boxed Warning for hepatotoxicity, such as hepatic veno-occlusive disease, as well as warnings for infusion-related reactions, sulfite allergic reactions, edema, and embryo-fetal toxicity.

The agency approved pivekimab sunirine at a dose of 0.045 mg/kg intravenously for approximately 15 to 30 minutes once every 3 weeks until progressive disease or unacceptable toxicity.

The FDA previously received a biologics license application for pivekimab sunirine in this BPDCN population in September 2025.²

References

1. FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy. News release. FDA. May 27, 2026. Accessed May 27, 2026. https://tinyurl.com/25ec2x49
2. AbbVie submits biologics license application (BLA) to U.S. FDA for pivekimab sunirine (PVEK) - an investigational antibody-drug conjugate (ADC) to treat rare cancer with limited treatment options. News release. AbbVie. September 30, 2025. Accessed May 27, 2026. https://tinyurl.com/ykzujenf