By: IPP Bureau
Last updated : October 01, 2025 3:56 pm
BPDCN is a challenging blood cancer with characteristics of both leukemia and lymphoma
AbbVie announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for its investigational therapy, Pivekimab sunirine (PVEK), for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). The application is supported by data from the global Phase 1/2 CADENZA trial, which evaluated the safety and efficacy of PVEK in patients with this aggressive and rare hematologic malignancy.
BPDCN is a challenging blood cancer with characteristics of both leukemia and lymphoma. Patients often present with skin lesions, and the disease commonly spreads to the bone marrow, central nervous system, and lymph nodes. Standard treatment typically involves intensive chemotherapy, often followed by stem cell transplantation. However, treatment options remain limited, particularly for patients who relapse or do not respond to prior therapies, underscoring the need for innovative approaches.
PVEK is a CD123-targeting Antibody-Drug Conjugate (ADC) in development for hematological cancers, including BPDCN and acute myeloid leukemia (AML). ADCs are designed to deliver a potent cancer cell–killing payload directly to tumor cells that express a specific protein. In BPDCN, CD123 (IL-3Rα) is overexpressed, making it a promising therapeutic target.
“Meaningful innovations in cancer research and treatment are happening every day. It is critical that these innovations reach patients who desperately need them, particularly those facing rare cancers with very few options,” said Roopal Thakkar, executive vice president, research and development and chief scientific officer, AbbVie. “With this BLA submission, we take an important step toward advancing treatment for people living with Blastic Plasmacytoid Dendritic Cell Neoplasm. Pivekimab sunirine represents our first Antibody-Drug Conjugate in blood cancers, and we look forward to the next steps in the regulatory review process.”