Pivekimab sunirine-pvzy cleared for blastic plasmacytoid dendritic cell neoplasm
- Sponsor
- AbbVie, Inc. $ABBV
- Drug
- Decnupaz · pivekimab sunirine-pvzy
- Indication
- blastic plasmacytoid dendritic cell neoplasm
FDA approved pivekimab sunirine-pvzy for adults with blastic plasmacytoid dendritic cell neoplasm based on CADENZA trial results.
What this means
Pivekimab sunirine-pvzy (brand name Decnupaz) is an antibody-drug combination that targets CD123, a protein found on certain blood cancer cells, to deliver chemotherapy directly to tumors. The FDA approved it for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive blood cancer, based on trial data showing nearly 70% of untreated patients achieved remission. The approval provides a targeted treatment option for this difficult-to-treat cancer, though warnings include potential liver damage and infusion reactions.
From the source
On May 27, 2026, the Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Full prescribing information for Decnupaz will be posted on Drugs@FDA.
Efficacy and Safety
Efficacy was evaluated in CADENZA (NCT03386513), 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. 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.
Recommended Dosage
The recommended pivekimab sunirine-pvzy dose is 0.045 mg/kg intravenously over approximately 15-30 minutes once every three weeks (21-day cycle) until disease progression or unacceptable toxicity. The dose should be calculated based on the patient’s actual body weight.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted priority review. Pivekimab sunirine-pvzy received breakthrough designation and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.
Follow the Oncology Center of Excellence on X: @FDAOncology.
Reproduced from FDA Drugs (Whats New) · view original · public domain or open-licensed government work