As AbbVie continues to capitalize on its ImmunoGen deal, the growth of commercial antibody-drug conjugate (ADC) Elahere, another of the acquired company’s clinical assets has crossed the FDA finish line.
The FDA on Wednesday announced the approval of AbbVie’s CD123-direct ADC pivekimab sunirine-pvzy, which will hit the market under the Decnupaz moniker, as a treatment for adults with the rare blood cancer blastic plasmacytoid dendritic cell neoplasm (BPDCN).
The condition is a rare and aggressive cancer of the bone marrow and blood that can also affect organs like the lymph nodes, spleen and skin. Most patients with BPDCN present with purple-colored skin lesions and the malignancy is often diagnosed in more men than women, with most patients aged 60 years and older.
The disease can be marked by characteristics similar to certain types of leukemia or lymphoma and may evolve from prior myelodysplastic syndrome or chronic myelomonocytic leukemia, according to the Dana-Farber Cancer Institute.
The FDA cleared Decnupaz based on data from the single-arm Cadenza trial, which assessed the drug conjugate in patients with either treatment-naïve or relapsed or refractory BPDCN without evidence of active central nervous system disease. The trial assessed efficacy based on the rate of complete remission or clinical complete remission (CR/CRc), according to the FDA.
In the study, 23 treatment-naïve patients—or around 70%—achieved a CR/CRc at a median follow-up of 21.5 months, with a median duration of CR/CRc clocking in at 9.7 months. In the relapsed or refractory cohort, 8 patients hit that target at a median follow-up of 24.1 months, and their median duration of CR/CRc was 9.2 months.
In its approval announcement, the FDA noted that Decnupaz carries a boxed warning for hepatotoxicity, or liver damage, including hepatic veno-occlusive disease. The drug’s prescribing information also includes warnings and precautions for infusion-related reactions, edema, sulfite allergic reactions and embryo-fetal toxicity, per the regulator.
AbbVie got its hands on Decnupaz back in 2023 when it agreed to lay out $10 billion for ImmunoGen and its then-recently approved ADC Elahare, which managed to grow sales (PDF) more than 40% to $690 million in 2025, according to AbbVie’s latest full-year earnings report.
Elahere won its initial FDA nod in platinum-resistant ovarian cancer in Nov. of 2022, shortly before AbbVie publicly swooped in on ImmunoGen.
For its part, Decnupaz’s path to approval was delayed slightly after ImmunoGen earlier that same year elected to tweak the pivotal program for the drug, which was then still known as pivekimab sunirine.
At the time, following conversations with the FDA, the company decided to focus its midstage Cadenza trial on BPCDN patients without prior or concomitant hematologic malignancy (PCHM), which pushed back an expected topline data readout by two years. The company made the decision after reviewing data from an initial 10 patients enrolled, regardless of whether they had PCHM.