Decnupaz (pivekimab sunirine-pvzy) approved in Adults with BPDCN

The FDA approved pivekimab sunirine-pvzy (Decnupaz; AbbVie), for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). It is the first and only antibody-drug conjugate (ADC) approved for blastic plasmacytoid dendritic cell neoplasm that is initiated in an outpatient setting. BPDCN is an ultra-rare and aggressive hematologic malignancy with limited treatment options.

Efficacy was evaluated in the phase 1/2 CADENZA trial, a multicenter, open-label, single-arm clinical trial that enrolled treatment-naive and relapsed or refractory BPDCN populations without active central nervous system disease. Among 33 treatment-naive patients, 23 achieved complete remission or clinical complete remission, for a CR/CRc rate of 69.7% with a median duration of 9.7 months. Among 51 patients with relapsed or refractory disease, 8 achieved CR/CRc, for a response rate of 15.7% and median duration of 9.2 months. 

The prescribing information for Decnupaz includes a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease, as well as warnings for infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity. The recommended dose is 0.045mg/kg intravenously over approximately 15-30 minutes once every 3 weeks until disease progression or unacceptable toxicity. Patients should be premedicated with a corticosteroid on the day prior to infusion and premedicated with a corticosteroid, antihistamine, and an antipyretic at least 30 to 60 minutes prior to infusion.