FDA Approves Decnupaz (pivekimab sunirine-pvzy) for Adult Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm – AbbVie
AbbVie announced that the FDA has approved Decnupaz (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.
“For patients living with rare cancers, progress in research can be life‑changing. 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.” – Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie.
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.
“BPDCN is an aggressive disease with historically limited therapeutic options, particularly for patients whose disease has relapsed or become refractory. 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.” – Naveen Pemmaraju, M.D., professor of leukemia, The University of Texas MD Anderson Cancer Center.
In the Phase 1/2 CADENZA trial, newly diagnosed patients with BPDCN who were treated with Decnupaz demonstrated clinically meaningful and durable responses. In newly diagnosed patients with BPDCN (n=33), researchers observed a composite complete response rate of 69.7% with a median duration of response of 9.7 months, with 13 patients (39.4%) who were able to receive post-study treatment stem cell transplant. Patients with relapsed or refractory disease (n=51) had a composite complete response rate of 15.7% with median duration of response rate of 9.2 months, with six patients (11.8%) who were able to receive post-study treatment stem cell transplant.
Most common adverse reactions (≥20%) were edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. Decnupaz has a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease, and warnings and precautions for infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity.
