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    Home > Medical News > Latest Medical News > Eli Lilly's new generation of BTK inhibitor LOXO-305 submits rolling application for marketing to FDA

    Eli Lilly's new generation of BTK inhibitor LOXO-305 submits rolling application for marketing to FDA

    • Last Update: 2021-12-26
    • Source: Internet
    • Author: User
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    On December 15th, Eli Lilly announced that it has submitted a rolling application (NDA) for the next-generation BTK inhibitor pirtobrutinib (LOXO-305) to the FDA for the treatment of mantle cell lymphoma


    From: Eli Lilly's official website

    LOXO-305 is an under-research, oral, highly selective non-covalent Bruton's tyrosine kinase (BTK) inhibitor


    In January 2019, Eli Lilly acquired Loxo Oncology for approximately US$8 billion and acquired a series of targeted anti-cancer drugs.


    LOXO-305 is also the fastest-growing product among the new generation of BTK inhibitors targeting the BTKC481S mutation


    According to the Insight database, the Chinese part of two head-to-head clinical trials of BRUINCLL-321 and BRUINMCL-321 have also been launched (CTR20212373, CTR20212310)


    Pirtobrutinib Phase 3 clinical development

    From: Eli Lilly's official website

    In December 2020, Eli Lilly announced the global multi-center phase I/II clinical data of LOXO-305 (Abstract 542) at the ASH conference.


    Eli Lilly's LOXO-305 has published clinical data

    From: Insight database (http://db.


    The results showed that among the 139 CLL/SLL patients who could be evaluated for efficacy, the overall response rate (ORR) was 63% (95%CI: 55-71)


    For patients with BTKC481 mutation and patients without BTKC481 mutation, the ORR was 71% (17/24) and 66% (43/65), respectively


    From: 2020ASH

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