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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

Yesterday: FDA approves Decnupaz for BPDCN

Overview

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

Decnupaz is also AbbVie's first antibody-drug conjugate approved for a blood cancer, a payoff 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, with responses lasting 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, broadening 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 the CADENZA trial, 69.7% reached complete or clinical complete remission.
9.7 months
Median response duration
How long complete remissions held at a median 21.5 months of follow-up.
~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

NP
Naveen Pemmaraju
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 regulator
Approving agency for Decnupaz

The federal agency that licenses prescription drugs sold in the United States.

Timeline

December 2018 May 2026

6 events Latest: Yesterday
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. CADENZA frontline data published

    Publication

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

  3. AbbVie files pivekimab BLA for BPDCN

    Regulatory

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

  4. AbbVie closes ImmunoGen acquisition

    Deal

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

  5. 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.

  6. 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.

Historical Context

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

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.

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.

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

(7)
+1
PR Newswire (AbbVie) The ASCO Post CancerNetwork U.S. Food and Drug Administration AbbVie Newsroom MD Anderson Cancer Center ApexOnco