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    Home > Medical News > Latest Medical News > Alis Medical's third-generation EGFR-TKI plans to be included in breakthrough treatment products

    Alis Medical's third-generation EGFR-TKI plans to be included in breakthrough treatment products

    • Last Update: 2022-01-14
    • Source: Internet
    • Author: User
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    ArticleMedicine Guanlan

    On November 23, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that the third-generation EGFR-TKI vometinib mesylate tablets of Allis Pharmaceuticals will be included in the breakthrough treatment product, and the proposed indication is : First-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) replacement mutation
    .

    Vometinib mesylate (trade name: Ivesa) is a category 1 innovative drug independently researched and developed by Iris Pharmaceuticals.
    It was approved for marketing in China in March 2021 for the treatment of past EGFR tyrosine kinases.
    Adult patients with locally advanced or metastatic NSCLC who have disease progression during or after treatment with inhibitors (TKI) and confirmed to have EGFR T790M mutation-positive

    .

    Public information shows that the uniqueness of vometinib as the third-generation EGFR-TKI is reflected in four aspects: First, it has dual-activity and differentiated characteristics.
    The main active metabolite AST5902 and the prototype drug AST2818 can be strongly inhibited.
    EGFR sensitive mutations and T790M resistant mutations; the second is high selectivity, that is, it only works on EGFR sensitive mutations, and has almost no inhibitory effect on wild-type; the third is safety, that is, there are few serious adverse reactions related to drugs, In the registered clinical studies of metinib, the incidence of all possible drug-related adverse reactions ≥3 grades were all <1.
    5%; the fourth is strong tumor shrinkage.
    Data from a single-arm clinical trial showed that vormetinib has an effect on EGFR The objective response rate (ORR) of T790M mutation-positive locally advanced or metastatic NSCLC patients was 74.
    1%

    .

    This time, vometinib is planned to be included in the breakthrough treatment category, and is the first-line treatment of NSCLC for the indications
    .
    According to a press release issued by Allis Medical in June this year, the first-line treatment of vomitinib is a phase 3 clinical treatment of locally advanced or metastatic NSCLC adult patients with EGFR exon 19 deletion or exon 21 (L858R) replacement mutations.
    The trial FURLONG has entered the data analysis stage.
    It is expected to apply for NDA this year and is expected to be approved in 2022

    .

    At the beginning of November, Allis Pharmaceuticals announced that vomitinib had reached the primary study endpoint of progression-free survival (PFS) in the phase 3 clinical study FURLONG
    .
    Compared with the control group receiving the first-generation EGFR-TKI treatment, the vometinib treatment group showed significant statistically and clinically significant PFS benefits

    .
    The specific data results of the research will be officially announced at future international academic conferences

    .

    In addition to the above two indications that have been approved and planned to be included in the breakthrough treatment category, the China Phase 3 Registered Clinical Study FORWARD for the adjuvant treatment of EGFR mutation-positive stage II-IIIA NSCLC patients with vomitinib has been published in It was officially launched in April this year
    .
    In addition, Iris Pharmaceuticals is actively exploring the clinical research of vometinib in other target mutations such as EGFR TExon20Ins

    .

    It is worth mentioning that in June this year, Allis Pharmaceuticals has reached an exclusive overseas licensing cooperation agreement with ArriVent Biopharma
    .
    The cooperation involves more than 800 million U.
    S.
    dollars, and ArriVent will obtain the exclusive overseas development and commercialization license rights for vomitinib

    .

    Reference materials:

    [1] Center for Drug Evaluation of China National Medical Products Administration.
    Retrieved Nov.
    23, 2021, from https:// | Affixa® first-line treatment of advanced NSCLC registration study achieved positive results.
    Retrieved Nov 1, 2021, from https:// Heavy!
    800 million US dollars + equity, Iris and ArriVent have reached an exclusive overseas license cooperation for vometinib.
    Retrieved Jun 30 2021, from https://mp.
    weixin.
    qq.
    com/s/Wgmtv-oZWprdPpkfEunxpg

    (The original text has been deleted)

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