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    Home > Medical News > Latest Medical News > The first EZH2 inhibitor approved by the FDA is applied for clinical application in China

    The first EZH2 inhibitor approved by the FDA is applied for clinical application in China

    • Last Update: 2021-06-02
    • Source: Internet
    • Author: User
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    On May 19, the CDE official website showed that the clinical application of Epizyme's Tazemetostat (tazemetostat) has been accepted by the State Food and Drug Administration, and it is the third domestic EZH2 inhibitor to be declared for clinical use.


    Polycomb inhibitory complex 2 (PRC2) is composed of three core subunits EZH2, EED and SUZ12 and many accessory proteins.


    Tazemetostat is a first in class histone lysine methyltransferase (EZH2) inhibitor, which can restore the expression of tumor suppressor genes by inhibiting the activity of the EZH2 enzyme in PRC2 to achieve tumor suppression.


    Tazemetostat structure (Source: NextPharma)

    Tazemetostat was first approved by the FDA on January 24, 2020 for the treatment of metastatic/locally advanced epithelioid sarcoma (ES) adults and pediatric patients 16 years and older who are not suitable for complete resection.


    A phase II clinical trial code-named EZH-202 evaluated the efficacy and safety of tazemetstat in patients with epithelioid sarcoma.


    Source: FDA instructions

    Another open-label, single-arm, multi-center phase II clinical study code-named E7438-G000-101 evaluated the efficacy of Tazemetostat in FL patients who have undergone at least second-line systemic treatment (r/r).


    Source: FDA instructions

    Currently in China, Hengrui's EZH2 inhibitor SHR2554 is currently in phase I clinical phase, and Shanghai Haihe Pharmaceutical Research Institute's EZH1/EZH2 inhibitor HH2853 has been approved for clinical use.


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