BRIEF—Nippon Shinyaku to develop and commercialize Menarini's tagraxofusp in Japan

Japanese firm Nippon Shinyaku has entered into an exclusive license agreement for the development and commercialization of tagraxofusp in Japan with family-owned Italian drugmaker Menarini.

Tagraxofusp has been approved for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) by the US Food and Drug Administration and the European Medicines Agency.

BPDCN is a rare aggressive hematologic malignancy with an extremely poor prognosis. Its treatment is based on intensive multiagent leukemia or lymphoma chemotherapy regimens in Japan. However, the median overall survival of patients with BPDCN is around 12 months, and new therapeutic agents are needed

Tagraxofusp has a mechanism of action to induce apoptosis of cells by inhibiting protein synthesis by specifically targeting cancer cells that express CD123.