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Tagraxofusp - Stemline Therapeutics

Drug Profile

Tagraxofusp - Stemline Therapeutics

Alternative Names: Diphtheria-toxin-interleukin-3-fusion-protein; DT(388)IL3; DT-388-IL-3; DT-IL-3; ELZONRIS; SL-401; tagraxofusp-erzs

Latest Information Update: 29 Aug 2019

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At a glance

  • Originator Scott & White Healthcare; Texas A&M University
  • Developer Dana-Farber Cancer Institute; Stemline Therapeutics
  • Class Antineoplastics; Bacterial toxins; Immunotoxins; Interleukins; Recombinant fusion proteins
  • Mechanism of Action Peptide elongation factor 2 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Acute myeloid leukaemia; Blastic plasmacytoid dendritic cell neoplasm
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Blastic plasmacytoid dendritic cell neoplasm
  • Phase II Acute myeloid leukaemia
  • Phase I/II Multiple myeloma; Myelodysplastic syndromes; Myeloproliferative disorders
  • Preclinical Systemic scleroderma
  • No development reported Hairy cell leukaemia

Most Recent Events

  • 06 Aug 2019 The Centers for Medicare & Medicaid Services grants approval for a new technology add-on payment (NTAP) for tagraxofusp for Blastic plasmacytoid dendritic cell neoplasm (In adolescents, In adults, In children)
  • 02 Aug 2019 Stemline Therapeutics plans a clinical trial for Acute myeloid leukaemia (Combination therapy) in by the first half of 2020
  • 02 Aug 2019 Stemline Therapeutics announces intention to launch tagraxofusp for Blastic plasmacytoid dendritic cell neoplasm in Europe in mid 2020
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