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

Latest Information Update: 16 Aug 2018

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At a glance

  • Originator Texas A&M University
  • Developer Stemline Therapeutics
  • Class Antineoplastics; Immunotherapies; Recombinant fusion proteins
  • Mechanism of Action Dendritic cell inhibitors; Interleukin-3-receptor-alpha-subunit-antagonists; 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
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Acute myeloid leukaemia
  • Phase I/II Multiple myeloma; Myelodysplastic syndromes; Myeloproliferative disorders
  • Preclinical Haematological malignancies; Hairy cell leukaemia; Systemic scleroderma
  • No development reported Chronic myeloid leukaemia; Lymphoma

Most Recent Events

  • 13 Aug 2018 FDA assigns PDUFA action date of 21/02/2019 for tagraxofusp for Acute myeloid leukaemia
  • 13 Aug 2018 US FDA grants Priority Review for tagraxofusp in Acute myeloid leukaemia
  • 09 Aug 2018 Stemline Therapeutics expects approval of Biologics License Application (BLA) for Acute myeloid leukaemia (Blastic plasmacytoid dendritic cell neoplasm) in USA in first quarter of 2019
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