FDA Approves Elzonris (tagraxofusp), the First Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm and First CD123-Targeted Therapy
FDA Approves Elzonris (tagraxofusp), the First Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm and First CD123-Targeted Therapy
Shots:
- The approval is based on the STML-401-0114 (NCT 02113982) study assessing immunophenotypic diagnostic CD123, CD4 & CD56 patients in treatment-naïve and previously-treated patients IV
- STML-401-0114 results: Elzonris(12 mcg/kg/day): ORR 90% (26/29); CR/CRc 72% (21/29); 45% of patients went for SCT post Elzonris treatment
- Elzonris is a CD123-targeted therapy indicate to treat adult and pediatric patients with both treatment-naïve and previously-treated BPDCN and has also received FDA’s BTD and ODD with its BLA
under review by the US FDA
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