The FDA on May 27, 2026 approved AbbVie’s DECNUPAZ (pivekimab sunirine-pvzy), which the agency’s approval summary describes as a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive blood cancer with few options. The openFDA registry lists application BLA761460 as approved under priority review, classified as a Type 1 new molecular entity with orphan designation.

DECNUPAZ is not the first CD123-targeted agent for the disease: tagraxofusp-erzs (Elzonris) was approved for BPDCN in 2018 and described by the FDA as the first CD123-targeted therapy. AbbVie’s narrower claim is that DECNUPAZ is “the first and only” CD123-targeting antibody-drug conjugate (the company’s own term for the mechanism) that can be initiated in an outpatient setting — a logistics distinction, not a clinical-benefit one.

The approval covers both newly diagnosed and relapsed or refractory BPDCN, and rests on the single-arm CADENZA study (NCT03386513), an AbbVie-sponsored Phase 1/2 open-label trial. Per ClinicalTrials.gov, the pre-specified primary endpoint was composite complete response rate (CR plus clinical CR) — a response-rate surrogate. Duration of response, the share of patients bridged to stem-cell transplant, and overall survival were secondary endpoints. There was no comparator arm.

What the data showed

Among 33 newly diagnosed patients, the composite complete response rate was 69.7% (95% CI 51.3-84.4), with a median duration of response of 9.7 months (95% CI 2.9 months to not estimable — the data are immature, and the upper bound has not been reached); 39.4% (13/33) went on to a post-treatment stem-cell transplant. Among 51 relapsed or refractory patients, the composite complete response rate was 15.7% (95% CI 7.0-28.6), with a median duration of response of 9.2 months; 11.8% (6/51) proceeded to transplant. The single best number, 69.7%, applies only to the newly diagnosed subgroup and should not be read as the drug’s overall efficacy.

Composite complete response is a response-rate surrogate. With no control arm, the trial has not demonstrated an overall-survival benefit, and the durability estimate remains immature.

The label carries a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease (also known as sinusoidal obstruction syndrome); per the FDA-approved prescribing information, DECNUPAZ “can cause hepatotoxicity, including severe or fatal hepatic VOD.” The trial protocol excluded patients with a prior history of veno-occlusive disease and with Grade 4 capillary leak syndrome, underscoring the toxicity profile of CD123-targeted agents.

DECNUPAZ is given intravenously on a 21-day cycle (0.045 mg/kg once every three weeks). AbbVie says it can be initiated in an outpatient setting.