Drug Update · Oncology

FDA Approves pivekimab sunirine for BPDCN: CR/CRc 69.7% in Treatment‑Naïve CADENZA

September 06, 2026

FDA approval date

05/27/2026

Indication

Treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Primary efficacy (treatment‑naïve CADENZA)

CR/CRc 69.7% (23/33; 95% CI: 51.3, 84.4)

Recommended dose (approved)

0.045 mg/kg IV once every 3 weeks

Clinical Perspective

This approval provides oncologists, hematologists, and advanced practice providers with an FDA‑approved CD123-directed antibody‑drug conjugate for adult patients with BPDCN ^[4]^[1]. The CADENZA data support CR/CRc activity in treatment‑naïve disease and more limited CR/CRc activity in relapsed/refractory BPDCN; clinicians should weigh the CR/CRc rates, duration of response data, and the safety profile — notably hepatotoxicity/VOD risk and infusion‑related reactions — when selecting patients and planning monitoring ^[7]^[1]^[4]. What remains to be defined is the optimal sequencing of Decnupaz relative to hematopoietic stem cell transplantation and how best to mitigate VOD risk in patients proceeding to transplant?

Dr. Meera Pillai, MBBS, MD (General Medicine), DM (Medical Oncology) · Oncology

Pivekimab sunirine-pvzy (Decnupaz, AbbVie) was approved by the U.S. Food and Drug Administration on May 27, 2026 for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) ^[4]^[1]. The approval was based on results from the single-arm CADENZA trial in which treatment‑naïve patients with BPDCN achieved a complete remission or clinical complete remission (CR/CRc) rate of 69.7% (23/33; 95% CI: 51.3, 84.4) with a median follow-up of 21.5 months ^[4]^[7].

Clinical Context

Pivekimab sunirine-pvzy (DECNUPAZ) is a CD123-directed antibody and alkylating-agent conjugate developed by AbbVie/ImmunoGen and is indicated for adult patients with BPDCN ^[1]^[4]^[7]. The agent targets CD123 (the alpha subunit of the interleukin-3 receptor) and delivers a cytotoxic payload (FGN849) that causes DNA alkylation and cell death after intracellular processing ^[7]. The approval followed review of data from CADENZA, a multicenter, open-label, single-arm study in patients with frontline or relapsed/refractory BPDCN and other CD123-positive hematologic malignancies ^[4]^[5]^[7]. Decnupaz was granted priority review, breakthrough therapy designation, and orphan drug designation during development ^[4]^[2].

Key Findings

In the CADENZA trial (treatment‑naïve BPDCN cohort, N=33), pivekimab sunirine-pvzy (Decnupaz) achieved a CR/CRc rate of 69.7% (23/33; 95% CI: 51.3, 84.4) with median follow-up 21.5 months; the median duration of CR/CRc was 9.7 months (95% CI: 2.9, not estimable) ^[7]^[4].
In the relapsed or refractory BPDCN cohort (N=51) of CADENZA, Decnupaz achieved a CR/CRc rate of 15.7% (8/51; 95% CI: 7.0, 28.6) with a median duration of CR/CRc of 9.2 months (range: 2.7, 27.6+) and median follow-up 24.1 months ^[4]^[7].
Efficacy in the primary analysis population (frontline de novo BPDCN) was reported as a composite CCR (CR + clinical CR) rate of 75% (15/20; 95% CI: 51 to 91) in the JCO primary analysis population; median overall survival in that cohort was 16.6 months (95% CI: 7.2, not reached) in the published report ^[6]^[7].
The FDA review cited CADENZA (NCT03386513) as the pivotal dataset supporting approval; full prescribing information and Drugs@FDA materials list the trial results and safety findings used in the decision ^[4]^[7].

Safety & Tolerability

Boxed Warning: Hepatotoxicity, including hepatic veno‑occlusive disease (VOD)/sinusoidal obstruction syndrome; VOD has been reported, including severe or fatal cases. Monitor liver tests and discontinue Decnupaz for patients who experience VOD ^[1]^[3]^[7].
VOD occurrence in CADENZA and pooled safety: VOD occurred in 6% (7/116) of adult patients during treatment or following subsequent HSCT; among 116 patients treated at 0.045 mg/kg, VOD occurred in 2/116 (2%) during treatment and in 5/19 (26%) of patients who proceeded to HSCT, including two fatal cases ^[1]^[7].
Clinicians should consult current prescribing information for full dosing guidance.
Infusion‑related reactions (IRR) were reported in 26% (30/116) of patients (Grade 1: 4.3% [5/116]; Grade 2: 16% [19/116]; Grade 3: 5% [6/116]); IRRs occurred in Cycle 1 in 25% (29/116) of patients and led to discontinuation in one patient. Premedication regimen and monitoring are recommended ^[1]^[7].
Other adverse reactions explicitly reported as common (≥20%) include edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea ^[1]^[7].
Laboratory abnormalities reported as common Grade 3 or 4 (≥10%) include decreased neutrophils, decreased platelets, decreased lymphocyte count, decreased white blood cells, decreased hemoglobin, and increased glucose ^[1]^[7].
Additional warnings/precautions in the label: sulfite allergic reactions due to sodium metabisulfite content, embryo‑fetal toxicity, edema and fluid retention, and dose adjustments or discontinuation guidance for hepatic and renal impairment ^[1]^[7].

Study Design

The FDA approval was supported by CADENZA (NCT03386513), a multicenter, open‑label, single‑arm clinical trial that enrolled adult patients with CD123‑positive hematologic malignancies, including treatment‑naïve BPDCN (N=33 in the treatment‑naïve BPDCN cohort) and relapsed/refractory BPDCN (N=51) ^[4]^[5]^[7]. Efficacy was evaluated by the rate of complete remission or clinical complete remission (CR/CRc) and duration of response; safety was assessed in a pooled population of 116 patients treated at the approved dose ^[5]^[7]. The FDA approved the BLA (BLA 761460) effective May 27, 2026 and required multiple postmarketing studies and trials to further characterize serious risks including post‑HSCT outcomes and infusion‑related reactions ^[3]^[2].

FAQ

Q1 What is pivekimab sunirine (Decnupaz) approved for?

Pivekimab sunirine-pvzy (Decnupaz) is approved for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The FDA approval was granted on May 27, 2026 based on efficacy and safety evidence from the CADENZA trial program in adults with frontline and relapsed/refractory BPDCN.

Q2 How does pivekimab sunirine work?

Pivekimab sunirine is a CD123-directed antibody-drug conjugate. The humanized anti-CD123 antibody binds CD123-expressing cells and, after internalization and intracellular processing, releases the payload FGN849 which leads to DNA alkylation, single-strand DNA breaks, apoptosis, and cell death.

Q3 What is the recommended dose of Decnupaz?

The recommended dose of Decnupaz is 0.045 mg/kg administered intravenously over approximately 15 to 30 minutes once every three weeks (21-day cycle) until disease progression or unacceptable toxicity. Premedication with corticosteroid the day before and corticosteroid, antihistamine, and antipyretic 30 to 60 minutes prior to infusion is recommended.

Q4 What are the most common side effects?

The most common adverse reactions (≥20%) reported with Decnupaz include edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. The label includes a boxed warning for hepatotoxicity including hepatic veno‑occlusive disease (VOD) and lists infusion‑related reactions, sulfite allergic reactions, edema, and embryo‑fetal toxicity among warnings and precautions.

Clinicians should consult current prescribing information for complete dosing guidance.

FDA Approves pivekimab sunirine for BPDCN: CR/CRc 69.7% in Treatment‑Naïve CADENZA

Direct Clinical Takeaway & Evidence Summary

FDA Approves pivekimab sunirine for BPDCN: CR/CRc 69.7% in Treatment‑Naïve CADENZA

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

Cite & Reference This Monograph

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