FDA approves AbbVie's Decnupaz for ultra-rare BPDCN blood cancer
New CapabilitiesSecond-ever therapy for the disease and the first that doctors can start outside a hospital
May 27th, 2026: FDA approves Decnupaz for BPDCNNew here? Follow stories to track developments over time. Create a free account to get updates when stories you care about change.
Overview
Updated May 28The 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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People Involved
Organizations Involved
Large-cap pharma spun out of Abbott Laboratories in 2013, built on Humira and now investing heavily in oncology.
The federal agency that licenses prescription drugs sold in the United States.
Italian drugmaker that owns Elzonris, the first approved BPDCN therapy, after acquiring Stemline Therapeutics for $677 million in 2020.
Timeline
December 2018 May 2026
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FDA approves Decnupaz for BPDCN
Latest ApprovalPivekimab sunirine-pvzy becomes the second drug ever approved for BPDCN and the first that can begin in an outpatient clinic.
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Menarini announces Elzonris combination data at ASCO 2026
ConferenceMenarini 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.
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CADENZA frontline data published
PublicationMD Anderson's Naveen Pemmaraju reports high complete-response rates in newly diagnosed BPDCN patients treated with pivekimab.
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AbbVie files pivekimab BLA for BPDCN
RegulatoryAbbVie submits its Biologics License Application based on CADENZA Phase 1/2 results.
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AbbVie closes ImmunoGen acquisition
DealAbbVie takes ownership of the pivekimab program along with ImmunoGen's antibody-drug conjugate platform.
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AbbVie agrees to buy ImmunoGen for $10.1 billion
DealThe deal is driven by Elahere, an ovarian-cancer ADC. Pivekimab comes along as a Phase 2 asset with breakthrough designation in BPDCN.
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FDA approves Elzonris, first BPDCN treatment
ApprovalStemline 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.
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.
The 2010 withdrawal cast doubt on the ADC class for blood cancers and slowed industry investment in the format.
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.
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.
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.
BPDCN patients had a first targeted option, but treatment required inpatient monitoring because capillary leak syndrome hit 53% of patients on trial.
Elzonris was the only approved BPDCN therapy for more than seven years and made CD123 the validated target for the disease.
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.
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.
The deal pushed AbbVie into the top tier of oncology revenue and gave it ImmunoGen's linker-payload platform for future ADCs.
Decnupaz is the second drug from the ImmunoGen deal to reach the market and the first AbbVie shepherded through approval after the close.
The approval is the first new launch AbbVie has produced from the ImmunoGen pipeline, beyond the Elahere franchise that justified the price.
