WASHINGTON (dpa-AFX) - AbbVie, Inc. (ABBV) announced Tuesday the submission of a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of investigational Pivekimab sunirine (PVEK) for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN).
The submission is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN, which is a rare and aggressive blood cancer that has features of both leukemia and lymphoma.
Patients typically present with skin lesions and the disease often spreads to the bone marrow, central nervous system and the lymph nodes. First-line treatments are typically intensive chemotherapy and often followed by stem cell transplant.
PVEK is a CD123-targeting Antibody-Drug Conjugate (ADC) in clinical development for hematological malignancies, including BPDCN and acute myeloid leukemia (AML). CD123 (IL-3R?) is a protein overexpressed in BPDCN, making it an ideal target for therapy.
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