AbbVie submits Biologics License Application (BLA) to U.S. FDA for Pivekimab sunirine (PVEK) an investigational ADC to treat rare cancer with limited treatment options

CAR-T Digest - August 2020

Weekly Digest - October 2025

30 September 2025: AbbVie submits Biologics License Application (BLA) to U.S. FDA for Pivekimab sunirine (PVEK) an investigational ADC to treat rare cancer with limited treatment options

AbbVie has submitted a BLA to the U.S. FDA for Pivekimab sunirine (PVEK), an investigational ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive blood cancer
The submission is supported by data from the Phase 1/2 CADENZA trial, evaluating safety and efficacy of PVEK in BPDCN and other CD123+ hematologic malignancies
PVEK targets CD123, a protein overexpressed in BPDCN, delivering a potent cytotoxic payload directly to cancer cells
The FDA previously granted Breakthrough Therapy designation (October 2020) for PVEK in relapsed/refractory BPDCN, highlighting its potential as a novel treatment option