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Talacotuzumab - CSL/Janssen Biotech

Drug Profile

Talacotuzumab - CSL/Janssen Biotech

Alternative Names: CSL 362AML; CSL-362; JNJ 473; JNJ 56022473; TAL

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator CSL
  • Developer CSL; Janssen Biotech
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Interleukin-3 receptor alpha subunit antagonists; Natural killer cell stimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Myelodysplastic syndromes
  • Discontinued Acute myeloid leukaemia; Systemic lupus erythematosus

Most Recent Events

  • 07 Feb 2022 Phase-II clinical trials in Myelodysplastic syndromes (Monotherapy, In adults, In the elderly, Second-line therapy or greater) in Italy (IV) (EudraCT2016-003328-22) (NCT03011034)
  • 05 Oct 2021 Janssen Research & Development completed phase II trial in Myelodysplastic syndromes (Monotherapy, In adults, In the elderly, Second-line therapy or greater) in USA, Spain, Italy, the Netherlands, Belgium, and Russia (IV) (EudraCT2016-003328-22) (NCT03011034)
  • 01 Dec 2018 Updated efficacy, adverse events and pharmacodynamics data from the phase II SAMBA trial in Acute myeloid leukaemia and Myelodysplastic syndromes presented at the 60th Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2018)
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