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FDA approves AbbVie's Decnupaz for ultra-rare BPDCN blood cancer

FDA approves AbbVie's Decnupaz for ultra-rare BPDCN blood cancer

New Capabilities

Second-ever therapy for the disease and the first that doctors can start outside a hospital

May 27th, 2026: FDA approves Decnupaz for BPDCN

Overview

Updated May 28

The FDA approved AbbVie's Decnupaz on May 27 for blastic plasmacytoid dendritic cell neoplasm, an aggressive blood cancer. It strikes an estimated few hundred Americans a year. It's the second drug ever approved for the disease and the first doctors can start in an outpatient clinic.

Decnupaz is AbbVie's first approved antibody-drug conjugate for a blood cancer, from its $10.1 billion purchase of ImmunoGen in 2024. In the CADENZA trial, 69.7% of newly diagnosed patients reached a complete or near-complete remission. Responses lasted a median of 9.7 months.

Why it matters

Newly diagnosed BPDCN patients can now begin treatment in a clinic instead of a hospital stay. This broadens access for a cancer often caught late.

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Key Indicators

69.7%
Complete response rate, frontline
Of 33 newly diagnosed patients in CADENZA, 69.7% reached complete or clinical complete remission.
9.7 months
Median response duration, frontline
How long complete remissions held at a median 21.5 months of follow-up.
15.7%
Complete response rate, relapsed/refractory
Of 51 relapsed or refractory patients in CADENZA, 15.7% reached complete or clinical complete remission, with a median response duration of 9.2 months.
~500
Estimated US cases per year
BPDCN incidence is below one per 100,000, with most patients male and over 60.
$10.1B
ImmunoGen purchase price
AbbVie's 2024 acquisition that brought pivekimab into its pipeline alongside Elahere.
2
Approved BPDCN therapies
Decnupaz joins Stemline's Elzonris, the first BPDCN drug, approved in December 2018.

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People Involved

Naveen Pemmaraju
Naveen Pemmaraju
Principal investigator, CADENZA trial
Chief of Myeloid Malignancies, MD Anderson Cancer Center

Organizations Involved

AbbVie (Allergan)
AbbVie (Allergan)
Pharmaceutical company
Decnupaz sponsor and manufacturer

Large-cap pharma spun out of Abbott Laboratories in 2013, built on Humira and now investing heavily in oncology.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulatory agency
Approving agency for Decnupaz

The federal agency that licenses prescription drugs sold in the United States.
Menarini Group
Menarini Group
Pharmaceutical company
Elzonris sponsor; presenting new tagraxofusp combination data at ASCO 2026

Italian drugmaker that owns Elzonris, the first approved BPDCN therapy, after acquiring Stemline Therapeutics for $677 million in 2020.

Timeline

December 2018 May 2026

7 events Latest: May 27th, 2026 · 4 months ago
Tap a bar to jump to that date

  1. FDA approves Decnupaz for BPDCN

    Latest Approval

    Pivekimab sunirine-pvzy becomes the second drug ever approved for BPDCN and the first that can begin in an outpatient clinic.

  2. Menarini announces Elzonris combination data at ASCO 2026

    Conference

    Menarini Group announced that new phase 2 tagraxofusp combination data in BPDCN will be presented by Naveen Pemmaraju at the ASCO 2026 Annual Meeting, starting May 29 in Chicago.

  3. CADENZA frontline data published

    Publication

    MD Anderson's Naveen Pemmaraju reports high complete-response rates in newly diagnosed BPDCN patients treated with pivekimab.

  4. AbbVie files pivekimab BLA for BPDCN

    Regulatory

    AbbVie submits its Biologics License Application based on CADENZA Phase 1/2 results.

  5. AbbVie closes ImmunoGen acquisition

    Deal

    AbbVie takes ownership of the pivekimab program along with ImmunoGen's antibody-drug conjugate platform.

  6. AbbVie agrees to buy ImmunoGen for $10.1 billion

    Deal

    The deal is driven by Elahere, an ovarian-cancer ADC. Pivekimab comes along as a Phase 2 asset with breakthrough designation in BPDCN.

  7. FDA approves Elzonris, first BPDCN treatment

    Approval

    Stemline Therapeutics' tagraxofusp-erzs becomes the first drug for BPDCN and the first CD123-targeted therapy approved in the United States.

Scenarios

1

Decnupaz becomes preferred frontline BPDCN regimen in NCCN guidelines

Likely Resolves by Nov 30, 2027

Discussed by: AbbVie investor materials, CancerNetwork coverage of CADENZA

The 69.7% complete response rate in newly diagnosed patients, combined with outpatient dosing, gives Decnupaz a real edge over Elzonris. NCCN panels typically refresh acute leukemia and BPDCN guidance every 6 to 12 months. If oncologists adopt Decnupaz quickly, the NCCN guideline would list it as the preferred frontline regimen within 18 months.

2

Real-world Decnupaz responses fall short of CADENZA trial data

Possible Resolves by May 27, 2028

Discussed by: Hematology academic centers, FDA postmarketing commitments

CADENZA enrolled trial-eligible patients at academic centers, a group that often outperforms typical community practice. BPDCN patients are usually older, with comorbidities and CNS involvement that trial protocols excluded. A real-world series of at least 50 frontline patients could land closer to the 53.8% rate seen for tagraxofusp.

3

AbbVie launches pivotal pivekimab program in another CD123-positive cancer

Possible Resolves by End of 2027

Discussed by: ApexOnco, AbbVie pipeline disclosures

CD123 is also expressed in acute myeloid leukemia, chronic myelomonocytic leukemia, and some myeloproliferative neoplasms. AbbVie has venetoclax in those settings and could pair it with pivekimab. A Phase 3 registration in AML or a CD123-positive MPN would mean BPDCN was the first proof point, not the only one.

4

FDA expands Decnupaz label to relapsed or refractory BPDCN

Likely Resolves by May 27, 2028

Discussed by: FDA review documents, AbbVie regulatory plans

CADENZA enrolled both frontline and relapsed/refractory patients, and the press release framed the initial approval around the newly diagnosed cohort. AbbVie is likely to file a supplemental BLA to cover patients whose disease has come back after Elzonris or chemotherapy. The supplemental review would set up Decnupaz as a full-spectrum BPDCN drug.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

May 2000 - September 2017

Mylotarg sets a cautionary precedent for blood-cancer ADCs (2000-2017)

In 2000, the FDA approved Pfizer's Mylotarg, a CD33-directed conjugate, as the first antibody-drug conjugate for any cancer and the first for acute myeloid leukemia. Pfizer withdrew Mylotarg in 2010 after a confirmatory trial showed no survival benefit and higher early death rates. The agency re-approved it in 2017 at a lower, fractionated dose.

Then

The 2010 withdrawal cast doubt on the ADC class for blood cancers and slowed industry investment in the format.

Now

The 2017 re-approval at a lower dose restored confidence in blood-cancer ADCs and showed that tolerability often depends as much on dosing as on the antibody-drug pair.

Why this matters now

Decnupaz is only the second ADC franchise actively used in a blood cancer, and the Mylotarg history shaped how AbbVie and the FDA structured its dose schedule and label.

December 2018

Elzonris approval opens BPDCN treatment (December 2018)

On December 21, 2018, the FDA approved Stemline Therapeutics' tagraxofusp-erzs as the first treatment for BPDCN and the first CD123-targeted therapy. The pivotal trial enrolled just 13 newly diagnosed patients; 7 of them (53.8%) reached complete or clinical complete response. Italian drugmaker Menarini bought Stemline for $677 million in 2020, mainly for the Elzonris franchise.

Then

BPDCN patients had a first targeted option, but treatment required inpatient monitoring because capillary leak syndrome hit 53% of patients on trial.

Now

Elzonris was the only approved BPDCN therapy for more than seven years and made CD123 the validated target for the disease.

Why this matters now

Decnupaz now competes against Elzonris on the same target Stemline pioneered, but with a different toxicity profile that lets doctors begin treatment outside the hospital.

November 2023 - February 2024

AbbVie buys ImmunoGen and inherits a BPDCN candidate (November 2023 - February 2024)

AbbVie announced a $10.1 billion all-cash deal for ImmunoGen on November 30, 2023, and closed it on February 12, 2024. The buy was driven by Elahere, an ovarian-cancer ADC that delivered $690 million of revenue in 2026. Pivekimab came along as a Phase 2 asset with FDA breakthrough designation in BPDCN.

Then

The deal pushed AbbVie into the top tier of oncology revenue and gave it ImmunoGen's linker-payload platform for future ADCs.

Now

Decnupaz is the second drug from the ImmunoGen deal to reach the market and the first AbbVie shepherded through approval after the close.

Why this matters now

The approval is the first new launch AbbVie has produced from the ImmunoGen pipeline, beyond the Elahere franchise that justified the price.

Sources

(11)
+5
PR Newswire (AbbVie) The ASCO Post CancerNetwork U.S. Food and Drug Administration AbbVie Newsroom MD Anderson Cancer Center ApexOnco GlobeNewswire Journal of Clinical Oncology OncLive Oncology Nursing News