A new Biologics License Application (BLA) has been submitted to the US Food and Drug Administration (FDA) for approval of the investigational therapy pivekimab sunirine 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 the therapy in BPDCN.
Pivekimab sunirine, developed by AbbVie, is a CD123-targeting antibody-drug conjugate in clinical development for hematological malignancies, including BPDCN and acute myeloid leukemia (AML).
Pivekimab sunirine is currently being evaluated as monotherapy for patients with BPDCN and in combination with azacitidine and venetoclax for patients with untreated and relapsed or refractory AML. In October 2020, it was granted Breakthrough Therapy designation by the FDA in relapsed or refractory BPDCN.
CADENZA is a phase 1/2 multicenter, open-label study designed to determine the maximum tolerated dose, recommended phase 2 dose, and recommended dosing schedule for pivekimab sunirine monotherapy and to assess the safety, tolerability, PK, immunogenicity, and antileukemia activity of the therapy when administered to subjects with CD123-positive hematologic malignancies, including BPDCN and AML, according to an AbbVie press release.
