CHMP recommends approval of Elzonris for blastic plasmacytoid dendritic cell neoplasm.- Menarini Group

The Menarini Group announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the approval of Elzonris (tagraxofusp) as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic malignancy with dismal outcomes. The positive opinion from the CHMP was based on the largest prospective clinical trial ever conducted in patients with treatment-naïve or previously-treated BPDCN. The CHMP opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization for human medicines throughout the European Union (EU). If approved, Elzonris will be the first and only treatment for BPDCN, and the first approved CD123-targeted therapy, available across the EU, to address this high unmet medical need. In July the CHMP did not recommend approval of Elzonris for blastic plasmacytoid dendritic cell neoplasm.