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    Home > Active Ingredient News > Endocrine System > 2021 Tumor New Drug Data Card - Darotamin

    2021 Tumor New Drug Data Card - Darotamin

    • Last Update: 2021-03-08
    • Source: Internet
    • Author: User
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    Based on the Pharmaceutical Rubik's Cube NextPharma database, NextMed database and public information, Pharmaceutical Rubik's Cube Med has launched a special "Oncology New Drug Data Card" to introduce some key information about the new cancer drug listed in China for your reference.
    darotamine Q1 basic information darotamine (Nubeqa, Norbigo) is a nonsteroidal androgen-inhibitor (ARi) developed jointly by Bayer/Orion, which has a unique chemical structure that binds to androgen-infused with high affinity to inhibit the function of the subject and the growth of prostate cancer cells.
    the drug was first approved by the FDA on July 30, 2019 for the treatment of non-metastatic desopathic prostate cancer (nmCRPC).
    approved in Japan and the European Union in 2020 and was officially approved by NMPA on February 2, 2021 through priority review and special approval.
    Q2-listed prostate cancer is the third most common cancer in the world, the second most common male malignancy in the world, and the fifth leading cause of death from cancer in men.
    2018, an estimated 1.2 million men worldwide will be diagnosed with prostate cancer and 358,000 will die from it.
    In 2019, 73,000 men in the United States were diagnosed with desopathic prostate cancer (CRPC), of which 40 percent had not metastatic cancer, testosterone was at descending levels but PSA levels were elevated, and such patients were non-metastatic descending against prostate cancer (nmCRPC).
    early diagnosis and timely intervention in the nmCRPC stage is of great significance for effectively preventing the metastasis of prostate cancer and prolonging the overall survival of patients.
    previously, androgen-infested (AR) inhibitors Apatamine (Johnson and Johnson) and Nzaluamine (Pfizer/Astellas) were approved for listing by NMPA in September and November 2019, respectively.
    apatamine was approved for treatment in adult patients with a high risk of metastasis.
    Nzaluamine was first approved for treatment in adult patients with metastatic desopathic prostate cancer (CRPC) who failed asymptomatic or mildly symptomatic and did not receive chemotherapy after the failure of androgen deprivation therapy (ADT), and a second adaptation was approved in November 2020 for the treatment of adult patients at high risk of metastasis nmCRPC.
    Q3 allergy darotemphetamine has been approved by the FDA and China as a non-metastatic despotic resistance prostate cancer (nmCRPC) with a high risk of metastasis.
    that the tumor has not spread to other parts of the body and is no longer effective for testosterone-lowering drugs or surgical treatments.
    Q4 treatment costs listed as a prostate cancer AR inhibitor, the latest lowest winning bids for apatamine (60mg/tablet) and nzaluamine (40mg/softgel) were RMB332.5 and RMB321.43, respectively.
    the latter has been successfully included in the 2020 National Health Insurance List, and the standard of payment for health care has not yet been published.
    2020 global sales rose 128.9 per cent to $760m, while Nzaluamine's global sales in 2020 were $1,024m, up 22 per cent, according to the company's financial results.
    , the listing price of darothamine in China has not yet been officially announced, its pricing strategy will become an important point of view.
    Q5 evidence-based data and core clinical in-period analysis of international multi-center Phase III ARAMIS clinical studies involving 1509 patients showed that the treatment of darothamim combined ADT significantly extended non-transferable despotic prostate cancer (NmCRPC) patients without metastatic survival (MFS) (40.4 vs. 18.4 months) compared to placebo joint standard ADT.
    in an article published in NEJM on September 10, 2020, the Kaplan-Meier Curve (source: NEJM) of MFS published the results of the final analysis of OS, secondary endpoint, and long-term safety in the Daroteamine III.ARAMIS study.
    follow-up to 3 years, the risk of death in the daroteamine group was significantly reduced by 31% (83% vs. 77%; HR, 0.69; 95% CI, 0.53-0.88; P - 0.003) compared to the placebo group.
    -Meier curve for total lifetime (Source: NEJM) OS benefits can be observed even if more than half of the patients in the placebo group follow up with darrowthamine therapy or another life-extending treatment.
    time that darotamine was first used with cytotoxic chemotherapy, the time of the first symptomatic skeletal event, and the time it took for pain to progress significantly longer, compared to placebo.
    the risk of side effects in the datrotamine group and the placebo group. At the time of the
    -year follow-up, secondary and exploratory endpoints of the intended treatment population (Source: NEJM) Currently, a number of core clinical trials of darotamin are currently under way in metastatic hormone-sensitive prostate cancer (combined androgen deprivation therapy) and limited prostate cancer excision or radiotherapy assisted therapy (combined androgen deprivation therapy ± in-body radiation therapy).
    Darotamine Core Clinical Layout Data Source: NextClinTrial Database, which retains only key clinical trials registered as drugs or aimed at changing guidelines; CSCO Prostate Cancer Guidelines (2020 edition) According to the 2020 CSCO Prostate Cancer Guidelines, nmCRPC patients with PSA-DT-gt;10 months may choose to observe or practice second-line endocrine therapy;
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