AbbVie announced on May 27 that the U.S. Food and Drug Administration has approved DECNUPAZ (pivekimab sunirine-pvzy) for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm, an ultra-rare and aggressive hematologic malignancy with limited treatment options. The approval is based on data from the Phase 1/2 CADENZA trial, which evaluated the safety and efficacy of DECNUPAZ for this indication.
“For patients living with rare cancers, progress in research can be life‑changing,” said Roopal Thakkar, executive vice president, research and development, chief scientific officer at AbbVie. “This approval delivers a new option for treating BPDCN and demonstrates our determination to drive meaningful advancements for patients affected by difficult-to-treat cancers.”
Blastic plasmacytoid dendritic cell neoplasm often presents with skin lesions and can quickly spread to bone marrow, lymph nodes, and the central nervous system. The disease typically affects adult men aged 60 to 70 years. Despite initial treatments such as intensive chemotherapy or stem cell transplantation, many patients experience relapse.
“BPDCN is an aggressive disease with historically limited therapeutic options, particularly for patients whose disease has relapsed or become refractory,” said Naveen Pemmaraju, M.D., professor of leukemia at The University of Texas MD Anderson Cancer Center. “Pivekimab sunirine-pvzy is the first and only CD123 targeting ADC that can be initiated in an outpatient setting, offering a meaningful benefit for BPDCN patients in need of new treatment alternatives.”
In the CADENZA trial involving newly diagnosed BPDCN patients treated with DECNUPAZ (n=33), a composite complete response rate of 69.7% was observed with a median duration of response of 9.7 months; 39.4% were able to receive post-study stem cell transplant. Among relapsed or refractory cases (n=51), there was a composite complete response rate of 15.7% and median duration of response was 9.2 months; 11.8% received post-study stem cell transplant.
DECNUPAZ carries a boxed warning for hepatotoxicity including hepatic veno-occlusive disease as well as warnings regarding infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity.
AbbVie operates in more than 175 countries through over 55,000 employees developing therapies across immunology, oncology and neuroscience areas while serving approximately 60 million people each year across more than 75 conditions, according to the official website.
