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A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

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Trial Profile

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2025

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At a glance

  • Drugs Asciminib (Primary) ; Bosutinib; Dasatinib; Imatinib; Nilotinib
  • Indications Chronic myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ASC4FIRST
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 31 Jul 2025 Planned End Date changed from 18 Jan 2028 to 18 Jan 2031.
  • 30 Jul 2025 According to a Novartis media release, Health Canada has granted a Notice of Compliance for Scemblix (asciminib tablets) and expands approval of Scemblix for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) who are newly diagnosed or who have previously received one or more tyrosine kinase inhibitors (TKIs). Scemblix, is now approved for newly diagnosed and previously treated CML.
  • 30 Jul 2025 Results presented in a Novartis media release

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