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# AbbVie’s NDA for Dendritic Cell Neoplasms Approved
- URL: https://www.fdaweb.com/abbvies-nda-for-dendritic-cell-neoplasms-approved/
- Published: 2026-05-27T12:00:00.000Z
- Updated: 2026-09-14T13:39:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161211

FDA has approved an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy), a CD123-directed antibody and alkylating agent conjugate for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The [agency says](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare?utm%5Fmedium=email&utm%5Fsource=govdelivery) the approval was based in data from the CADENZA (NCT03386513) study, a multicenter, open-label, single-arm clinical trial that included adult patients with treatment-naïve BPDCN (N=33) or relapsed or refractory BPDCN (N=51), without evidence of active central nervous system disease. Efficacy was based on the rate of complete remission or clinical complete remission (CR/CRc).

“In patients with treatment-naïve BPDCN (N = 33), 23 patients (69.7%; 95% CI: 51.3, 84.4) achieved a CR/CRc with a median follow-up of 21.5 months,” it says. “The median duration of CR/CRc was 9.7 months (95% CI: 2.9, not estimable). In patients with relapsed or refractory BPDCN (N = 51), 8 patients (15.7%; 95% CI: 7.0, 28.6) achieved a CR/CRc with a median follow-up of 24.1 months. The median duration of CR/CRc was 9.2 months (Range: 2.7, 27.6+).”

The prescribing information includes a Boxed Warning for hepatotoxicity, including hepatic veno-occlusive disease, and warnings and precautions for infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity, according to the agency.