AbbVie (ABBV) announced that the U.S. Food and Drug Administration (FDA) has approved DECNUPAZ for the treatment of adult patients with Blastic plasmacytoid dendritic cell neoplasm or BPDCN, an ultra-rare hematologic malignancy.
BPDCN is a rare and aggressive blood cancer that typically affects adult men aged 60-70 years, and the patients often present with skin lesions. The disease can rapidly spread to the bone marrow, lymph nodes, and central nervous system.
DECNUPAZ (pivekimab sunirine-pvzy) is a CD123-targeting antibody-drug conjugate or ADC for the treatment of adult patients diagnosed with the haematological malignancy BPDCN.
Notably, DECNUPAZ marks AbbVie's first ADC approved for the treatment of blood cancer. The approval was backed by data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of DECNUPAZ for BPDCN.
CADENZA is a Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and anti-leukaemia activity of pivekimab sunirine-pvzy in patients with CD123-positive hematologic malignancies, including BPDCN.
In the CADENZA trial, newly diagnosed BPDCN patients treated with DECNUPAZ demonstrated clinically meaningful and durable responses, including a composite complete response rate of 69.7% and a median response duration of 9.7 months, with 13 patients (39.4%) receiving post-study treatment, including stem cell transplantation.
Meanwhile, DECNUPAZ has a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease, and warnings and precautions for infusion-related reactions, oedema, sulfite allergic reactions, and embryo-fetal toxicity.
ABBV has traded between $181.73 and $244.81 over the last year. The stock closed Wednesday's trade at $215.40, up 1.07%.
In the overnight market, ABBV is down 0.06% at $215.28.
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