Health
U.S. FDA Approves DECNUPAZTM (pivekimab sunirine-pvzy) for Treatment of Adult Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm, an Ultra-Rare and Aggressive Blood Cancer With Limited Treatment Options
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved DECNUPAZTM (pivekimab sunirine-pvzy) for the treatment of adult patients with BPDCN, an ultra-rare and aggressive hematologic malignancy with limited treatment options. The approval is supported by data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of DECNUPAZ for BPDCN.
About this update from Abbvie Inc.
[{"type":"text","content":"- DECNUPAZ is the first and only antibody-drug conjugate (ADC) approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN) that is initiated in an outpatient setting- DECNUPAZ marks AbbVie's first ADC approved for blood cancer","length":237,"tagName":"p","attribs":{}},{"type":"text","content":"NORTH CHICAGO, Ill., May 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved DECNUPAZTM (pivekimab sunirine-pvzy) for the treatment of adult patients with BPDCN, an ultra-rare and aggressive hematologic malignancy with limited treatment options. The approval is supported by data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of DECNUPAZ for BPDCN.","length":462,"tagName":"p"},{"type":"text","content":""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, 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."","length":403,"tagName":"p"},{"type":"text","content":"Patients with BPDCN often present with skin lesions, and the disease can rapidly spread to the bone marrow, lymph nodes, and central nervous system. The disease typically affects adult men aged 60-70 years. Despite initial treatment with intensive chemotherapy, which may include stem cell transplantation, many patients experience relapse, underscoring the need for new treatment options.1","length":390,"tagName":"p"},{"type":"text","content":""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, 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."","length":491,"tagName":"p"},{"type":"text","content":"In the Phase 1/2 CADENZA trial, newly diagnosed patients with BPDCN who were treated with DECNU...