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    Home > Biochemistry News > Biotechnology News > Innovative Mechanism of Action Novartis Leukemia Therapy Receives FDA Approval

    Innovative Mechanism of Action Novartis Leukemia Therapy Receives FDA Approval

    • Last Update: 2021-12-03
    • Source: Internet
    • Author: User
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    On October 30, Novartis announced that the US FDA approved Scemblix (asciminib) for the treatment of two different indications for chronic myeloid leukemia (CML)
    .
    The FDA has accelerated the approval of Scemblix for the treatment of Philadelphia (Ph) chromosome-positive CML patients in the chronic phase who have previously received two or more tyrosine kinase inhibitors (TKI) treatments

    .
    At the same time, the FDA fully approved it for the treatment of the above-mentioned patients with the T315I mutation

    .
    The press release pointed out that Scemblix is ​​the first CML therapy combined with the myristoyl pocket of ABL1, providing an important new treatment option for patients who are resistant or intolerant to current TKI therapies

    .

    CML is a malignant myeloproliferative tumor that occurs in pluripotent hematopoietic stem cells.
    It is characterized by a significant increase in granulocytes in the peripheral blood.
    In some CML patients, Ph chromosome and/or BCR-ABL fusion genes can be found

    .
    For many patients, current therapies are limited by intolerance and drug resistance, and patients with T315I mutations are resistant to most TKIs, so the risk of disease progression increases

    .

    Scemblix is ​​an allosteric inhibitor against ABL1, which inhibits the activity of BCR-ABL1 by binding to the myristoyl pocket of ABL1
    .
    Because its binding site with BCR-ABL1 is different from common TKI, it may solve the problem of TKI resistance and intolerance in the later treatment of CML patients

    .

    ▲Scemblix's mechanism of action (picture source: reference [2])

    This approval is based on the results of a phase 3 clinical trial and a phase 1 clinical trial
    .
    The results of the phase 3 clinical trial showed that Scemblix almost doubled the patient's major molecular response rate (MMR) in 24 weeks compared with the active control (25.
    5% vs.
    13.
    2%, p=0.
    029)

    .
    Moreover, the proportion of patients who stopped receiving treatment due to adverse reactions was one third of the control group (7% vs.
    25%)

    .

    Note: The original text has been deleted

    Reference materials:

    [1] FDA approves Novartis Scemblix® (asciminib), with novel mechanism of action for the treatment of chronic myeloid leukemia.
    Retrieved October 29, 2021, from https:// 29/2323914/0/en/FDA-approves-Novartis-Scemblix-asciminib-with-novel-mechanism-of-action-for-the-treatment-of-chronic-myeloid-leukemia.
    html

    [2] Hughes, et al.
    (2019).
    Asciminib in Chronic Myeloid Leukemia after ABL Kinase Inhibitor Failure.
    NEJM, DOI: 10.
    1056/NEJMoa1902328

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