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    Association details:
    Biomarker:No biomarker
    Cancer:Cholangiocarcinoma
    Drug:Truseltiq (infigratinib) (FGFR inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    BridgeBio
    Title:

    BridgeBio Pharma And Affiliate QED Therapeutics Announce FDA Acceptance Of New Drug Application For Infigratinib For The Treatment Of Cholangiocarcinoma

    Published date:
    12/01/2020
    Excerpt:
    BridgeBio Pharma, Inc...announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for infigratinib, an oral FGFR1-3 selective inhibitor, for individuals with cholangiocarcinoma, or cancer of the bile ducts....The NDA has been granted Priority Review designation and is being reviewed under the Real-Time Oncology Review (RTOR) pilot program...