AbbVie submits BLA to FDA for Pivekimab sunirine to treat rare blood cancer

AbbVie (ABBV) announced submission of a new Biologics License Application, or BLA, to the FDA for approval of investigational Pivekimab sunirine, or PVEK, for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm, or 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. BPDCN 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. In October 2020, the FDA granted PVEK Breakthrough Therapy designation in relapsed/refractory BPDCN.