As AbbVie continues to leverage its deal with Immunogen to grow its commercially available antibody-drug conjugate (ADC) Elahia, another clinical asset of the acquired company has crossed the FDA finish line.
The FDA announced Wednesday that it has approved AbbVie’s CD123 direct ADC pivekimab sunilin-pvzy, which will be brought to market under the name Decnupaz, for the treatment of adults with the rare blood cancer blastic plasmacytoid dendritic cell neoplasm (BPDCN).
This condition is a rare, aggressive cancer of the bone marrow and blood that can also affect organs such as the lymph nodes, spleen, and skin. Most patients with BPDCN present with purplish skin lesions, this malignancy is more common in men than women, and most patients are over 60 years of age.
The disease is characterized by features similar to certain types of leukemia and lymphoma and can develop from previous myelodysplastic syndromes or chronic myelomonocytic leukemia, according to the Dana-Farber Cancer Institute.
The FDA granted approval for Decnupaz based on data from the single-arm Cadenza trial, which evaluated the drug combination in patients with untreated, relapsed, or refractory BPDCN without evidence of active central nervous system disease. According to the FDA, the trial evaluated efficacy based on complete response or clinical complete response (CR/CRc) rates.
In this study, 23 treatment-naïve patients (approximately 70%) achieved CR/CRc with a median follow-up of 21.5 months, with a median duration of CR/CRc of 9.7 months. In the relapsed or refractory cohort, eight patients achieved goal with a median follow-up of 24.1 months, with a median CR/CRc duration of 9.2 months.
In its approval announcement, the FDA noted that Decnupas carries a boxed warning regarding hepatotoxicity or liver damage, including hepatic veno-occlusive disease. The drug’s prescribing information also includes warnings and precautions regarding infusion-related reactions, edema, sulfite allergic reactions, and embryofetal toxicity, according to the regulatory agency.
AbbVie acquired Decnupus in 2023 when Decnupus agreed to inject $10 billion with Immunogen into its then recently approved ADC Elahair, which helped it grow sales (PDF) more than 40% to $690 million in 2025, according to AbbVie’s most recent full-year earnings report.
Elahere won initial FDA approval for the treatment of platinum-resistant ovarian cancer in November 2022, just before AbbVie publicly entered ImmunoGen.
Decnupas’ path to approval, meanwhile, was delayed slightly earlier that year when Immunogen opted to tweak a pivotal program for the drug, then still known as pivekimab sunirin.
At the time, the company, in consultation with the FDA, decided to focus on the mid-stage Cadenza trial in BPCDN patients with or without pre-existing hematologic malignancies (PCHM), which delayed expected topline data readout by two years. The company made its decision after reviewing data from the first 10 patients enrolled, with and without PCHM.
