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-3Ra) is a protein overexpressed in BPDCN, making it an ideal target for therapy.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.