The FDA has cleared the use of AbbVie’s antibody-drug conjugate for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm. The drug will carry the brand name Decnupaz.
Decnupaz is the first and so far only antibody-drug conjugate (ADC) approved for this indication, according to the company’s Wednesday news release. The approval also marks AbbVie’s first ADC entry in the blood cancer space.
The FDA’s decision was backed by data from the Phase 1/2 CADENZA study, which enrolled 33 treatment-naive patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and 51 patients with relapsed or refractory BPDCN. None of the patients had signs of central nervous system disease.