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    Home > Medical News > Latest Medical News > AstraZeneca/Daiichi Sankyo's new ADC indication has been granted priority review by the FDA

    AstraZeneca/Daiichi Sankyo's new ADC indication has been granted priority review by the FDA

    • Last Update: 2022-02-22
    • Source: Internet
    • Author: User
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    On January 17, AstraZeneca and Daiichi Sankyo announced that they had received notification from the U.


    Breast cancer is the most common cancer worldwide, with more than 2 million cases diagnosed in 2020 and nearly 685,000 deaths worldwide


    The new indication sBLA is being reviewed under the Real-Time Oncology Review (RTOR) project, which allows the US FDA to review components of an application before submitting a full application, and the Orbis project for participating international partners (Japan, EU and other countries) provides a framework for simultaneous submission and review of oncology drugs


    There was a clear trend towards improvement in overall survival (OS) for Enhertu (HR=0.


    "This regulatory review of Enhertu in the U.


    In March 2019, AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize Enhertu


    References:

    [1] ENHERTU® Granted Priority Review in the US for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen.


    (Original abridged)

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