FDA Approves DECNUPAZ with 69.7% Response Rate in Rare BPDCN
ABBV•FDA approves DECNUPAZ (pivekimab sunirine-pvzy), AbbVie’s first antibody-drug conjugate for blastic plasmacytoid dendritic cell neoplasm in adults aged 60-70. The Phase 1/2 CADENZA trial recorded a 69.7% complete response rate in 33 frontline patients and 15.7% in 51 relapsed/refractory patients, with median durations near 9.5 months.
1. Approval Details
The U.S. Food and Drug Administration granted approval to DECNUPAZ (pivekimab sunirine-pvzy) for treating adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), marking AbbVie’s first antibody-drug conjugate approved for a hematologic malignancy and the first outpatient-initiated ADC for this ultra-rare disease.
2. Clinical Trial Results
In the Phase 1/2 CADENZA trial, newly diagnosed BPDCN patients (n=33) achieved a 69.7% composite complete response rate with a median duration of response of 9.7 months, while relapsed or refractory patients (n=51) recorded a 15.7% rate with a 9.2-month median response duration.
3. Therapy Profile and Safety
DECNUPAZ targets the CD123 antigen on BPDCN cells to deliver a DNA-alkylating payload that induces apoptosis. Common adverse reactions include edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea and diarrhea, and the therapy carries a boxed warning for hepatotoxicity, including veno-occlusive disease.
4. Market and Financial Implications
AbbVie’s approval of DECNUPAZ opens a new revenue stream in an area with no outpatient ADC options and reflects its strategy to expand its oncology portfolio. However, the ultra-rare nature of BPDCN may limit peak sales and the overall patient population size.
