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    Association details:
    Biomarker:BCR-ABL1 fusion
    Cancer:Leukemia
    Drug:Scemblix (asciminib) (Bcr-abl tyrosine kinase inhibitor, STAMP inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Chronic Myeloid Leukemia)
    New
    Title:

    FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukemia

    Excerpt:
    On October 29, 2024, the Food and Drug Administration granted accelerated approval to asciminib (Scemblix, Novartis AG) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Study to determine the dose and safety of asciminib in pediatric patients with chronic myeloid leukemia

    Excerpt:
    ...No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly• Prior treatment with a minimum of one TKI.• Failure or intolerance to the most recent TKI therapy at the time of screening.• Evidence of typical BCR-ABL fusion gene (BCR-ABL1) transcript [e14a2 and/or e13a2] at the time of screening which are amenable to standardized real time quantitative polymerase chain reaction (RQ-PCR) quantification.`...
    Trial ID:
    2021-001286-20
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2023
    Title:

    Efficacy and Safety of Asciminib in Chinese Patients with Philadelphia Chromosome(Ph)-Positive Leukaemias

    Published date:
    11/02/2023
    Excerpt:
    Asciminib demonstrated promising clinical efficacy with satisfactory tolerance in this cohort of Ph+ leukaemias failing multiple lines of therapy.
    DOI:
    https://doi.org/10.1182/blood-2023-185578