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    Home > Active Ingredient News > Drugs Articles > Ivosidenib receives FDA priority review, an article to understand the new progress of targeted therapy for cholangiocarcinoma

    Ivosidenib receives FDA priority review, an article to understand the new progress of targeted therapy for cholangiocarcinoma

    • Last Update: 2021-07-01
    • Source: Internet
    • Author: User
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    Derazantinib is an oral small molecule FGFR inhibitor under investigation, which has strong activity on FGFR1, 2 and 3
    .
    Derazantinib has been certified as an orphan drug for the treatment of cholangiocarcinoma in the United States and the European Union
    .


    In a single-arm phase II study, a total of 44 patients with intrahepatic cholangiocarcinoma were enrolled and divided into three groups non-randomly, FGFR2 fusion group (N=29), FGFR mutation/amplification group (N=6) and no FGFR Gene abnormality group (N=9)
    .


    research shows


    The ORR of the FGFR2 fusion group and FGFR mutation/amplification group were 21% and 0%, respectively; the DCR of the FGFR2 fusion group and FGFR mutation/amplification group were 83% and 67%, respectively, and the DCR of patients without FGFR2 abnormality was 22% ; The mPFS of FGFR2 fusion group and FGFR mutation/amplification group were 5.
    7 and 6.
    7 months, respectively
    .


    The results of this study confirm that Derazantinib has broad potential as a monotherapy for patients with cholangiocarcinoma with multiple FGFR2 gene mutations
    .


    Infigratinib


    (BGJ398)


    Infigratinib is a selective oral FGFR1~FGFR3 inhibitor
    .


    The results of its phase II trial were announced at the 2021 Gastrointestinal Cancer Symposium.
    The study recruited 140 patients with unresectable locally advanced or metastatic cholangiocarcinoma who were intolerant or diseased to gemcitabine-based chemotherapy Progressive patient
    .


    research shows


    Among 108 evaluable patients, the objective response rate was 23.
    1%, including 1 complete remission, 24 partial remission, 66 patients with stable disease and 11 patients with disease progression
    .
    The disease control rate was 84.
    3%, and the median duration of remission was 5 months
    .


    It can be seen from the above research results that Infigratinib has good anti-cancer activity in patients with advanced refractory cholangiocarcinoma
    .
    At present, Infigratinib has obtained the qualification of an orphan drug for cholangiocarcinoma granted by the FDA
    .


    In addition to the progress of the above-mentioned drugs in the treatment of cholangiocarcinoma, there are also other targeted drugs that are constantly deepening.
    We also look forward to more targets in the field of targeted therapy of cholangiocarcinoma to be included in the study, bringing patients More benefits are possible
    .


    reference:


    1.
    Servier Announces FDA Filing Acceptance and Priority Review for TIBSOVO? (ivosidenib tablets) in IDH1-mutated Cholangiocarcinoma.
    Retrieved May 5, 2021, from https:// filing-acceptance-and-priority-review-for-tibsovo-ivosidenib-tablets-in-idh1-mutated-cholangiocarcinoma-301283821.
    html;


    2.
    https://
    3.
    https://

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