On May 27, AbbVie announced that Decnupaztm (Pivekimab sunirine-pvzy) has received FDA approval for the treatment of adult patients with blastic plasmacytoid dendritic cell tumors (BPDCN).
Pivekimab sunirine-pvzy is the world's first approved CD123 ADC . CD123 (IL-3Rα) is a protein overexpressed in BPDCN and is an ideal therapeutic target.
This approval is supported by data from the Phase I/II CADENZA study. This study was a multicenter, open-label clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and antileukemic activity of pivekimab sunirine-pvzy in patients with CD123-positive hematologic malignancies, including BPDCN.
The results showed that newly diagnosed BPDCN patients treated with pivekimab sunirine-pvzy exhibited clinically significant and durable responses. In newly diagnosed BPDCN patients (n=33), the overall complete response rate was 69.7%, with a median duration of response (DOR) of 9.7 months, and 13 patients (39.4%) were able to receive stem cell transplantation after the study. In relapsed or refractory BPDCN patients (n=51), the overall complete response rate was 15.7%, with a median DOR of 9.2 months, and 6 patients (11.8%) were able to receive stem cell transplantation after the study .
The most common adverse reactions (≥20%) were edema, fatigue, musculoskeletal pain, bleeding, infusion-related reactions, nausea, and diarrhea. Decnupaztm has a black box warning for hepatotoxicity (including hepatic venous occlusive disease) and warnings and precautions for infusion-related reactions, edema, sulfite allergy, and embryo-fetal toxicity.
BPDCN is an extremely rare and aggressive hematologic malignancy with limited treatment options. Patients with BPDCN often develop skin lesions, and the disease can rapidly spread to the bone marrow, lymph nodes, and central nervous system. It typically affects adult men aged 60-70. Despite initial intensive chemotherapy, which may include stem cell transplantation, many patients experience relapse and require new treatment options.

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