New Treatment for a Rare Blood Cancer (BPDCN) in Adults

Decnupaz (pivekimab sunirine-pvzy; Patient Information / Snapshot pronunciation DEK-nuh-paz) is a CD123-directed antibody and alkylating agent conjugate given by intravenous infusion. On the USPI it is supplied as a lyophilized cake that requires reconstitution followed by two dilutions before administration. It is labelled for adult BPDCN, not as a pediatric BPDCN label on this USPI.

Distinct path — not this carton (fact-only): Other CD123-directed products exist in BPDCN care (for example tagraxofusp / Elzonris on separate labelling). Those are different molecules and different labels. Today’s Decnupaz commercial door is the AbbVie US BPDCN label described here. Do not treat another CD123 product’s schedule or warnings as this carton.

The FDA approved BLA 761460 on 27 May 2026 (Novel Drug Approvals for 2026 table row 17). Approval letter signed R. Angelo de Claro, MD, Director, Office of Oncologic Diseases (electronic signature ROMEO A DE CLARO, 05/27/2026 12:53:37 PM). Applicant / manufactured by: AbbVie Inc., North Chicago, IL 60064. The application was not referred to an FDA advisory committee. Reference ID 5805240. USPI revised 5/2026. Pediatric studies under PREA were waived for less than 6 months of age (impossible or highly impracticable — BPDCN extremely rare in that age group) on the letter narrative retrieved for this draft.

Where this is taking place

Commercial labelled door today: United States — FDA approval for adults with BPDCN. This is a hematology / leukemia clinic conversation with infusion-center logistics, liver-test monitoring, VOD vigilance (especially around transplant), and labelled premedication — not a casual retail pickup and not a DIY import.

Outside the United States: As of this draft, no confirmed Health Canada Notice of Compliance, European Commission marketing authorisation, MHRA licence, TGA ARTG listing, Swissmedic authorisation, or PMDA/MHLW licence for Decnupaz / pivekimab sunirine. Do not import on your own.

CADENZA — NCT03386513 (USPI Study) — Phase 1/2, multicenter, open-label, single-arm. Lead sponsor on ClinicalTrials.gov: AbbVie. CT.gov status: ACTIVE, NOT RECRUITING. Actual enrolment 179 on the record retrieved for this draft. Study Director on the record: ABBVIE INC. (AbbVie). Countries with listed sites include the United States, France, Germany, Italy, Spain, and the United Kingdom. Expanded access: CT.gov record retrieved for this draft lists hasExpandedAccess: false — no expanded access listed on that record. Not a new-enrolment path for newly labelled commercial use — the pivotal efficacy populations that support the label are already described on the USPI; follow-up continues.

The practical door in the US is a hematology clinician who can confirm BPDCN, arrange Decnupaz 0.045 mg/kg every 3 weeks with labelled premeds, monitor liver tests before each dose, watch for VOD / edema / infusion reactions, and plan transplant referral when appropriate — not treating NCT03386513 as open recruitment.

Approval matrix

Access by country

• United States: Ask a hematology / leukemia clinic about FDA-labelled Decnupaz. Labelled 27 May 2026 for adults with BPDCN. Recommended dose: 0.045 mg/kg IV over approximately 15–30 minutes once every 3 weeks until progression or unacceptable toxicity. Premedicate with dexamethasone 8 mg (or equivalent) twice daily the day before, and with IV dexamethasone 8 mg, IV diphenhydramine 25–50 mg, and oral acetaminophen 325–650 mg 30–60 minutes before infusion. Strength: 2 mg single-dose vial (NDC 0074-0282-02). Prior authorisation and specialty-pharmacy / infusion-center logistics still apply. No list price or copay dollars in this article. Suspected adverse reactions: AbbVie Inc. 1-800-633-9110 or FDA MedWatch 1-800-FDA-1088. Product information contact on label materials: DECNUPAZ.com / 1-800-633-9110. This is US commercial labelled supply, not a DIY import.

• Canada: Decnupaz authorisation not confirmed. Do not assume SAP, named-patient, or cross-border mail-order is available or appropriate. Ask the Canadian hematology clinic what legal paths exist in Canada when a Decnupaz Canadian label does not yet exist.

• European Union / United Kingdom / other countries with trial sites: Regulator authorisation not confirmed in this draft. Trial participation is not a commercial Decnupaz label.

• If your regulator has not authorised it: do not import on your own. Ask the local hematology clinician about documented special-access / named-patient rules, referral to a centre in a labelled country, or waiting — without treating a US vial as a foreign carton.

Who is eligible (from the US label)

This is an adult BPDCN conversation on the USPI — not a paediatric BPDCN label on sources confirmed for this draft.

United States (USPI / Medication Guide, revised / issued May 2026):

• Indication: Treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
• Recommended dosage: 0.045 mg/kg intravenously over approximately 15–30 minutes once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Calculate dose on actual body weight.
• Premedications: Day before — corticosteroid (dexamethasone 8 mg twice daily, oral or IV). Day of — corticosteroid (dexamethasone 8 mg IV), antihistamine (diphenhydramine 25–50 mg IV), antipyretic (acetaminophen 325–650 mg oral) 30–60 minutes prior to infusion.
• Preparation: Reconstitution followed by two dilutions — infusion-center pharmacy workflow.
• Contraindications: None listed in USPI §4.
• Pregnancy / contraception: Can cause fetal harm. Females of reproductive potential: effective contraception during treatment and for 7 months after the last dose. Males with female partners of reproductive potential: effective contraception during treatment and for 4 months after the last dose.
• Lactation: Advise not to breastfeed during treatment and for 1 month after the last dose.
• Hepatic / renal impairment: Avoid use in moderate to severe hepatic impairment and in moderate to severe renal impairment (USPI highlights).
• Pediatrics: Safety and effectiveness not established for this indication on the USPI (PREA waiver narrative on letter for <6 months).
• Trial context (CADENZA efficacy cohorts): no active CNS disease in the labelled efficacy populations described on the USPI.

Not labelled on sources confirmed for this draft:

• Children / adolescents for this indication.
• EU, UK, Canadian, Japanese, Australian, or Swiss Decnupaz marketing authorisations (not confirmed here).
• Treating CADENZA follow-up as open commercial enrolment.
• Substituting another CD123 product’s dose or warnings for this Decnupaz carton.

What the pivotal study showed (CADENZA / USPI)

Use the USPI for a US prescription conversation. Journals and conference abstracts are supportive reading.

CADENZA — NCT03386513:

• Multicenter, open-label, single-arm; labelled efficacy cohorts: 33 adults with treatment-naïve BPDCN without CNS involvement; 51 adults with relapsed/refractory BPDCN without active CNS disease; dose 0.045 mg/kg IV q3 weeks.
• Safety population on USPI: 116 adults with newly diagnosed or relapsed/refractory myeloid malignancies (including 84 with BPDCN) at the approved dose.
• Major efficacy outcome: CR/CRc (CRc = complete remission with residual skin abnormality not indicative of active disease).

USPI Table 7 (treatment-naïve BPDCN, N=33):

USPI Table 9 (relapsed/refractory BPDCN, N=51):

Trial-status honesty: CADENZA supports the US label. CT.gov remains ACTIVE, NOT RECRUITING because follow-up continues — that is not a door for new commercial starters outside labelled US distribution. No expanded access is listed on the CT.gov record retrieved for this draft.

How it is taken (US label — keep this exact)

Safety (what the label puts first)

Boxed warning — Hepatotoxicity including hepatic VOD: Decnupaz can cause severe or fatal hepatic VOD. In CADENZA, VOD occurred in 6% (7/116) overall; among 19 BPDCN patients who proceeded to HSCT, VOD occurred in 5/19 (26%), including two fatal cases (median onset 11 days after subsequent HSCT, range 7–25). Monitor ALT, AST, and total bilirubin before each dose. Permanently discontinue for VOD.

Infusion-related reactions: Premedicate as labelled. Interrupt, slow, or permanently discontinue based on severity.

Edema: All-grade edema 52%; Grade 3/4 edema 16%. Delay / reduce / discontinue per label; weigh weekly when indicated.

Sulfite allergic reactions: Contains sodium metabisulfite.

Embryo-fetal toxicity: Contraception windows as above (7 months after last dose for females; 4 months for males with partners of reproductive potential).

Most common adverse reactions (≥20%): edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea.

Selected Table 3 rates (N=116): edema 52% (Grade 3/4 16%); fatigue 34%; musculoskeletal pain 34%; hemorrhage 28%; infusion-related reactions 26%; nausea 24%; diarrhea 21%.

Serious ARs: 55%. Fatal ARs 4.3%. Permanent discontinuation 10% (VOD and pneumonitis among ≥1%). Dosage interruptions 37%; dose reductions 6%.

Drug interactions (high level): Closely monitor with strong and moderate CYP3A inhibitors (may increase unconjugated FGN849 exposure).

Report suspected adverse reactions to AbbVie 1-800-633-9110 or FDA MedWatch 1-800-FDA-1088.

How to talk to a doctor

Bring the brand, the INN, the BLA / NCT numbers, and the US Prescribing Information if you are in a US clinic. Outside the US, bring honesty that a local Decnupaz label may not exist yet.

1. “I am an adult with BPDCN. The FDA approved Decnupaz (pivekimab sunirine-pvzy) on 27 May 2026. Is that labelled for me in this country?”
2. “The labelled dose is 0.045 mg/kg IV every 3 weeks with day-before and day-of premeds. How will the infusion center prepare reconstitution and the two dilutions?”
3. “CADENZA (NCT03386513) showed CR/CRc 69.7% in treatment-naïve disease and 15.7% in relapsed/refractory disease. What does that mean for my care plan and transplant timing?”
4. “Please cover the boxed VOD / liver warning — how often will ALT, AST, and bilirubin be checked, and what symptoms mean I should call right away?”
5. “Please cover edema, infusion reactions, infection risk, and sulfite allergy questions.”
6. “I am not asking you to substitute another CD123 product’s label for this Decnupaz carton.”
7. “Please plan pregnancy testing and contraception (7 months after last dose if I can become pregnant; 4 months if I have a partner who can). Advise on breastfeeding rules (1 month after last dose).”
8. “Please review my other medicines for CYP3A interactions.”
9. “Is prior authorisation started? Who coordinates the 2 mg vials (NDC 0074-0282-02) and infusion scheduling?”
10. “Ex-US Decnupaz authorisations are not confirmed on the sources we are using. I will not import a foreign vial.”

Research and regulatory team (from sources only — no invented contacts)

Names and roles as they appear on primary sources — not a clinic directory.

• AbbVie Inc., North Chicago, IL 60064 — BLA 761460 applicant; USPI manufacturer; AE line 1-800-633-9110.
• AbbVie — ClinicalTrials.gov lead sponsor for NCT03386513.
• ABBVIE INC. — Study Director role named on the CT.gov record for CADENZA (trial leadership, not a national referral desk).
• R. Angelo de Claro, MD — Director, Office of Oncologic Diseases — signed the 27 May 2026 approval letter.
• Site-level hospital phone numbers are not listed here — ask your own hematology clinician.

Canada zoom: Decnupaz not confirmed

There is no retrieved Health Canada Notice of Compliance or DIN for Decnupaz / pivekimab sunirine on the sources used for this draft. US FDA approval does not create a Canadian Product Monograph. Do not treat cross-border mail-order of a US vial as the care plan. Ask a Canadian hematology clinician what legal options exist while waiting for any future Canadian Decnupaz decision.

Bottom line

Decnupaz (pivekimab sunirine-pvzy) is an FDA-approved CD123-directed antibody–drug conjugate — labelled 27 May 2026 (BLA 761460) for adults with BPDCN. Dose: 0.045 mg/kg IV every 3 weeks with labelled premedication. CADENZA (NCT03386513) showed CR/CRc 69.7% in treatment-naïve disease and 15.7% in relapsed/refractory disease. Watch VOD / hepatotoxicity (boxed), infusion reactions, edema, sulfite reactions, and pregnancy. US labelled. Other major regulators not confirmed. The door is a hematology clinic writing the US label — pivotal follow-up is not a new commercial enrolment path. Authorized is not funded.

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Primary sources

1. FDA Novel Drug Approvals for 2026 — Decnupaz / pivekimab sunirine-pvzy, approval date 5/27/2026, row 17 — https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
2. FDA oncology approval notice — FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare
3. FDA Drug Trials Snapshot: DECNUPAZ — https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-decnupaz
4. AbbVie Prescribing Information PDF — Decnupaz (pivekimab sunirine-pvzy), revised 5/2026 — https://www.rxabbvie.com/pdf/decnupaz_pi.pdf
5. FDA BLA approval letter, BLA 761460, signed R. Angelo de Claro, MD, 27 May 2026 — https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761460Orig1s000ltr.pdf
6. ClinicalTrials.gov NCT03386513 — CADENZA — https://clinicaltrials.gov/study/NCT03386513