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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: 09 Dec 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

  • 25 Nov 2025 According to a Novartis media release, data from the trial will be presented at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition and 2025 San Antonio Breast Cancer Symposium
  • 21 Nov 2025 Planned End Date changed from 18 Jan 2031 to 18 Jan 2028.
  • 17 Oct 2025 According to a Novartis media release, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion and recommended granting marketing authorization for Scemblix for the treatment of adult pts with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase in all lines of treatment. Following the CHMP's recommendation, the European Commission will make a final decision within 2 months.

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