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SL-401 in Patients With Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

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Trial Profile

SL-401 in Patients With Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 09 Apr 2025

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At a glance

  • Drugs Tagraxofusp (Primary)
  • Indications Acute myeloid leukaemia; Blastic plasmacytoid dendritic cell neoplasm
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Stemline Therapeutics

Most Recent Events

  • 28 Mar 2025 According to a Nippon Shinyaku media release, based on the results of Phase I/II trials conducted overseas in untreated and relapsed/refractory BPDCN patients, tagraxofusp has been approved by European Medicines Agency for adult patients with newly diagnosed BPDCN in January 2021.
  • 28 Mar 2025 According to a Nippon Shinyaku media release, company submitted a New Drug Application (NDA) to the Ministry of Health, Labour & Welfare (MHLW) for the manufacturing and marketing approval of NS-401 (tagraxofusp) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in Japan.
  • 10 Dec 2024 Results (n=66) of a sub-analysis assessing changes in specific hematologic laboratory parameters to determine hematopoietic and bone marrow effects of TAG treatment in adult patients with BPDCN over time presented at the 66th American Society of Hematology Annual Meeting and Exposition

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