AbbVie’s DECNUPAZ Approved by FDA for BPDCN Treatment

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. 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 60-70years. Despite initial treatment with intensive chemotherapy, which may include stem cell transplantation, many patients experience relapse, underscoring the need for new treatment options. 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, researchers observed a composite complete response rate of 69.7% with a median duration of response of 9.7 months, with 13 patients who were able to receive post-study treatment stem cell transplant. Patients with relapsed or refractory disease had a composite complete response rate of 15.7% with median duration of response rate of 9.2 months, with six patients who were able to receive post-study treatment stem cell transplant."