AbbVie's CD123 ADC approved for market launch

AbbVie (ABBV.US) announced that the U.S. FDA has approved its ADC therapy Pivekimab sunirine (PVEK) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). This is the first CD123 ADC approved for marketing worldwide and AbbVie's first approved hematologic malignancy ADC. BPDCN is a highly aggressive rare hematologic malignancy that combines features of leukemia and lymphoma. Patients typically present with skin lesions, and the disease can spread to the bone marrow, central nervous system, and lymph nodes. The current standard first-line treatment regimen consists mainly of high-intensity chemotherapy, with some patients requiring stem cell transplantation later on. However, overall treatment options are limited. There is a significant unmet clinical need for safer and more effective innovative targeted therapies for both newly diagnosed patients and those who have relapsed or are refractory after chemotherapy. Pivekimab sunirine is a CD123-targeted ADC developed for the treatment of hematologic malignancies. CD123 is highly expressed with high specificity in BPDCN tumor cells, making it an ideal therapeutic target for the disease. The U.S. FDA granted breakthrough therapy designation for this drug in October 2020 for BPDCN. The FDA approval was primarily based on data from the global multicenter Phase I/II CADENZA clinical trial, with the main endpoint being the composite complete response rate (CR+CRc).