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The FDA on May 27, 2026 approved Decnupaz (pivekimab sunirine-pvzy), AbbVie's CD123-directed antibody-drug conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm, a disease the agency calls an ultra-rare hematologic malignancy.
The antibody binds CD123, the alpha subunit of the interleukin-3 receptor, and releases a payload that alkylates DNA and breaks its strands. Tagraxofusp, approved in 2018, reaches the same target as a cytotoxin fused to interleukin-3 rather than as a conjugate.
CADENZA treated 33 patients who had never been treated and 51 with relapsed or refractory disease, all at 0.045 mg/kg every three weeks. Among the untreated, 69.7% reached complete remission or complete remission with residual skin abnormality, lasting a median of 9.7 months, and 39.4% went on to a transplant. In relapsed or refractory disease the rate was 15.7%.
A boxed warning covers hepatotoxicity, including fatal veno-occlusive disease, with liver tests required before every dose.
Pivekimab sunirine came from ImmunoGen, which AbbVie bought for $10.1 billion in a deal that closed in February 2024 and was pitched on a different conjugate. CADENZA was single-arm, and both response rates stand in the labeled population.
Sources: FDA prescribing information; Drugs@FDA, BLA 761460; FDA approval notice; AbbVie press release; AbbVie completes ImmunoGen acquisition, February 2024; FDA approval of tagraxofusp, 2018
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