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    Home > Biochemistry News > Biotechnology News > Novartis Kymriah's third indication enters the review treatment r/r FL in the U.S. and Europe

    Novartis Kymriah's third indication enters the review treatment r/r FL in the U.S. and Europe

    • Last Update: 2021-12-04
    • Source: Internet
    • Author: User
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    Novartis recently announced that the U.


    Previously, the FDA has granted Kymriah the Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of r/r FL; the European Commission (EC) has granted Kymriah the Orphan Drug Designation (ODD) for the treatment of FL


    Kymriah is a CD19-directed genetically modified autologous T cell immune cell therapy


    Kymriah is the first CAR-T cell therapy approved by the US FDA.


    This new indication application is based on the positive data of the key Phase 2 ELARA trial


    Note: The original text has been deleted

    Original source: Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah® to treat patients with relapsed or refractory follicular lymphoma

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