AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has approved DECNUPAZTM (pivekimab sunirine-pvzy), first and only antibody-drug conjugate (ADC) drug for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), an ultra-rare and aggressive hematologic malignancy with limited treatment options in adult patients. The approval is supported by data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of DECNUPAZ for BPDCN. DECNUPAZ marks as AbbVie’s first ADC approved treatment for blood cancer.
Patients suffering from BPDCN often have skin lesions, and the disease can rapidly spread to the bone marrow, lymph nodes, and central nervous system. The disease typically affects aged adult men around 60-70 years. Despite initial treatment with intensive chemotherapy, which may include stem cell transplantation, many patients experience relapse, underscoring the need for new treatment options
Most common adverse reactions (≥20%) of DECNUPAZTMwere edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. DECNUPAZTM has a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease, and warnings and precautions for infusion-related reactions, edema, sulfiteallergic reactions, and embryo-fetal toxicity.
Written by: Pramit Hazra
Graphics by : Pramit Hazra
