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    Home > Active Ingredient News > Antitumor Therapy > Clin Cancer Res: Tucatinib has been approved to treat advanced HER2-positive breast cancer.

    Clin Cancer Res: Tucatinib has been approved to treat advanced HER2-positive breast cancer.

    • Last Update: 2020-10-28
    • Source: Internet
    • Author: User
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    Tukysa (Tucatinib) Tokatini/Tucateni (ONT-380) is an oral TKI (Tyrosine kinase) inhibitor that is highly specific to HER2, but has no significant inhibitory effect on EGFR in the human skin growth factor family.
    On April 17, 2020, the FDA approved tucatinib co-curtoju single resistance and carpestabin treatment for patients with advanced breast cancer who are non-surgically removable or metastasis HER2-positive, including those who have received one or more anti-HER2-based programs after metastasis.
    the first new molecular entity evaluated in orbis, the FDA Cancer Center of Excellence program.
    approval is based on the HER2CLIMB test.
    HER2CLIMB trial was a randomized clinical trial in which 612 patients were treated with tucatinib or placebo combined querceto-bead monoantigen and carpentry.
    study showed that tucatinib significantly extended patients' progression-free survival (PFS: 7.8 months vs 5.6 months) compared to placebos (HR 0.54, 95% CI 0.42-0.71, p.lt;0.00001) and overall survival (OS: 21.9 months vs 17.4 months) (HR 0.66, 95% CI 0.50-0.87, p-0.00480).
    patients who received treatment, were in stable condition, or had active brain metastasis accounted for 48% of the study population.
    patients with brain metastasis benefit from tucatinib therapy (HR 0.48, 95% CI 0.34-0.69, p.lt;0.0001).
    of patients with brain metastasis allow this particular population to be included in the adaptation.
    adverse reactions include diarrhea and liver toxicity, which are listed in medication alerts and preventive measures.
    , this article summarizes tucatinib's FDA approval process and support data.
    the original text for specific content.
    .
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