OnCo
drugsProductNot mapped hereapproved

Pivekimab sunirine

Pivekimab sunirine is an antibody-drug conjugate against CD123, approved in 2026 for blastic plasmacytoid dendritic cell neoplasm as the second targeted drug for this rare cancer.

CADENZA pivotal study in untreated BPDCN: high complete response rates with fewer capillary-leak events than tagraxofusp. FDA approval May 2026. Also studied in CD123+ AML with azacitidine-venetoclax.

Schematic of the modality · ADC (anti-CD123 antibody, IGN payload) · not a molecule; see the Antibody-drug conjugate (ADC) page
How it works, step by step · animated schematic, not to scale
Antibody-drug conjugate (ADC)
Modality
ADC (anti-CD123 antibody, IGN payload)
Mechanism
Anti-CD123 antibody conjugated via a cleavable linker to an indolinobenzodiazepine pseudodimer (IGN) that alkylates DNA without cross-linking.
Brand / code
Decnupaz · IMGN632
Not appraisedSearch NICE
Notes
No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
NHS England
Not routinely funded

Sources: NICE search: pivekimab sunirine. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2026Blastic plasmacytoid dendritic cell neoplasm

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
1 studies1 recruiting1 Phase 21 Phase 3
Search “Pivekimab sunirine” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Pivekimab sunirine
intervention: Pivekimab sunirine
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Pivekimab sunirine" OR ABSTRACT:"Pivekimab sunirine" OR TITLE:"Decnupaz" OR ABSTRACT:"Decnupaz" OR TITLE:"IMGN632" OR ABSTRACT:"IMGN632") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Pivekimab sunirine, not a curated reading list.

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