U.S. FDA approves DECNUPAZ for adult patients with BPDCN, a rare aggressive Blood cancer

CAR-T Digest - August 2020

Weekly Digest - May 2026

27 May 2026: U.S. FDA approves DECNUPAZ for adult patients with BPDCN, a rare aggressive Blood cancer

AbbVie has secured U.S. FDA approval for DECNUPAZ in blastic plasmacytoid dendritic cell neoplasm (BPDCN), strengthening its hematologic oncology portfolio in an ultra-rare, high-mortality malignancy where treatment options remain extremely limited and outcomes are often poor
The approval was supported by results from the Phase 1/2 CADENZA trial, where newly diagnosed BPDCN patients achieved a 69.7% composite complete response rate and patients with relapsed or refractory disease achieved a 15.7% composite complete response rate with durable responses, while several patients also proceeded to stem cell transplant following treatment
DECNUPAZ becomes the first ADC approved for BPDCN and the only therapy in the indication that can be initiated in an outpatient setting, potentially reducing treatment burden, minimizing hospitalization requirements, and improving patient access compared with existing treatment approaches
By targeting CD123 and delivering an indolinobenzodiazepine pseudodimer payload, DECNUPAZ expands the application of ADC technology beyond solid tumors and into niche hematologic malignancies, further validating targeted payload delivery strategies in difficult-to-treat blood cancers
Strategically, the approval marks AbbVie’s first ADC approval in hematologic oncology, establishing a foothold in the CD123-directed treatment landscape and reinforcing the company’s broader ambition to expand its ADC franchise beyond solid tumors into high-unmet-need hematologic indications