Chemistry:Pivekimab sunirine
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| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | CD123 |
| Clinical data | |
| Trade names | Decnupaz |
| Other names | IMGN-632, pivekimab sunirine-pvzy |
| AHFS/Drugs.com | decnupaz |
| License data | |
| Routes of administration | Intravenous |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| UNII | |
Pivekimab sunirine, sold under the brand name Decnupaz, is an anti-cancer medication used for the treatment of blastic plasmacytoid dendritic cell neoplasm.[1] It is a CD123-directed antibody and alkylating agent conjugate.[1] It is given by intravenous injection.[1]
Pivekimab sunirine was approved for medical use in the United States in May 2026.[2]
Medical uses
Pivekimab sunirine is indicated for the treatment of adults with blastic plasmacytoid dendritic cell neoplasm.
Adverse effects
The US 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.[2]
History
Efficacy was evaluated in CADENZA (NCT03386513), a multi-center, open-label, single-arm clinical trial that included adult participants with treatment-naïve blastic plasmacytoid dendritic cell neoplasm (N=33) or relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (N=51), without evidence of active central nervous system disease.[2] Efficacy was based on the rate of complete remission or clinical complete remission.[2]
Society and culture
Legal status
Pivekimab sunirine was approved for medical use in the United States in May 2026.[3]
The US Food and Drug Administration granted the application for pivekimab sunirine priority review, breakthrough therapy, and orphan drug designations.[2]
Names
Pivekimab sunirine is the international nonproprietary name.[4]
Pivekimab sunirine is sold under the brand name Decnupaz.[2]
References
- ↑ 1.0 1.1 1.2 1.3 "Decnupaz FDA label". https://www.rxabbvie.com/pdf/decnupaz_pi.pdf.
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 "FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendriti". FDA. 27 May 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare.
This article incorporates text from this source, which is in the public domain.
- ↑ "U.S. FDA Approves Decnupaz (pivekimab sunirine-pvzy) for Treatment of Adult Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm, an Ultra-Rare and Aggressive Blood Cancer With Limited Treatment Options" (Press release). AbbVie. 27 May 2026. Retrieved 28 May 2026 – via PR Newswire.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87". WHO Drug Information 36 (1). 2022.
Further reading
- "Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm". Journal of Clinical Oncology 44 (10): 861–873. April 2026. doi:10.1200/JCO-25-02083. PMID 41671533.
- "Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): 2025 Update on Diagnosis, Pathophysiology, Risk Assessment, and Management". American Journal of Hematology 100 (8): 1408–1422. August 2025. doi:10.1002/ajh.27737. PMID 40525728.
External links
- Clinical trial number NCT03386513 for "Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN" at ClinicalTrials.gov
- "Pivekimab Sunirine ( Code - C184834 )". https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C184834.
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