# DECNUPAZ (pivekimab sunirine-pvzy) PDUFA Event: Blastic plasmacytoid dendritic cell neoplasm

Canonical URL: https://biopharmsignal.com/pdufa-calendar/ABBV/pivekimab-sunirine-bpdcn

Ticker: ABBV

Company: AbbVie Inc

Event date: 2026-07-30

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-05-27

Application type: BLA

FDA approved DECNUPAZ for adults with BPDCN. FDA approved DECNUPAZ for adults with blastic plasmacytoid dendritic cell neoplasm. The approval established the...

## Event Timeline

### May 27, 2026 — FDA approved DECNUPAZ for adults with BPDCN

FDA approved DECNUPAZ for adults with blastic plasmacytoid dendritic cell neoplasm. The approval established the first antibody-drug conjugate for BPDCN that can be initiated in an outpatient setting and occurred before the reported July 30 decision date.

[FDA — DECNUPAZ BLA approval letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761460Orig1s000ltr.pdf)

### February 11, 2026 — CADENZA results were published

Results from the Phase 1/2 CADENZA study of pivekimab sunirine in BPDCN were published online in the Journal of Clinical Oncology.

[ClinicalTrials.gov — CADENZA study record and publication](https://clinicaltrials.gov/study/NCT03386513)

### September 30, 2025 — AbbVie submitted the BLA

AbbVie submitted the pivekimab sunirine BLA for BPDCN based on data from the global Phase 1/2 CADENZA trial.

[AbbVie — Pivekimab sunirine BLA submission](https://news.abbvie.com/2025-09-30-AbbVie-Submits-Biologics-License-Application-BLA-to-U-S-FDA-for-Pivekimab-sunirine-PVEK-an-Investigational-Antibody-Drug-Conjugate-ADC-to-Treat-Rare-Cancer-with-Limited-Treatment-Options)

### November 17, 2020 — FDA granted Orphan Drug designation

FDA granted Orphan Drug designation to pivekimab sunirine for the treatment of BPDCN.

[FDA — Pivekimab sunirine orphan designation](https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=781620)

### October 2020 — FDA granted Breakthrough Therapy designation

FDA granted Breakthrough Therapy designation to pivekimab sunirine for relapsed or refractory BPDCN.

[AbbVie — Breakthrough Therapy designation history](https://news.abbvie.com/2023-12-10-ImmunoGen-Presents-Findings-from-Newly-Diagnosed-Acute-Myeloid-Leukemia-Cohorts-in-Phase-1b-2-Study-of-Pivekimab-Sunirine-in-Combination-with-Azacitidine-and-Venetoclax-at-ASH)

### December 29, 2017 — CADENZA was registered

The Phase 1/2 study was first posted on ClinicalTrials.gov to evaluate pivekimab sunirine in untreated and relapsed or refractory BPDCN and other CD123-positive hematologic malignancies.

[ClinicalTrials.gov — CADENZA study record](https://clinicaltrials.gov/study/NCT03386513)

## Regulatory Designations

- Breakthrough Therapy FDA: [AbbVie — Breakthrough Therapy status for pivekimab sunirine in BPDCN](https://news.abbvie.com/2025-09-30-AbbVie-Submits-Biologics-License-Application-BLA-to-U-S-FDA-for-Pivekimab-sunirine-PVEK-an-Investigational-Antibody-Drug-Conjugate-ADC-to-Treat-Rare-Cancer-with-Limited-Treatment-Options)

- Orphan Drug FDA: [FDA — Pivekimab sunirine orphan designation and approval](https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=781620)

## Related Pages

- ABBV PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/ABBV.md

- ABBV company profile: https://biopharmsignal.com/company/ABBV.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md