AbbVie secures US regulatory clearance for Decnupaz, targeting blastic plasmacytoid dendritic cell neoplasm, an ultra-rare malignancy.
The US Food and Drug Administration approved AbbVie’s Decnupaz (pivekimab sunirine) for treating blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive hematologic cancer. The therapy, a CD123-directed antibody conjugated with an alkylating agent, carries a boxed warning for hepatotoxicity.
Approval was based on clinical trial results, though specific efficacy data was not disclosed. BPDCN is an ultra-rare malignancy with limited treatment options, often requiring intensive chemotherapy or stem cell transplants. Decnupaz offers a targeted alternative for patients with this high-unmet-need condition.
AbbVie’s shares showed minimal movement following the announcement, reflecting the niche market size and limited immediate revenue impact.