英文药名：Tagrisso Tablets（Osimertinib Mesilate） 中文药名：甲磺酸塔格瑞斯片 生产厂家：阿斯利康 タグリッソ錠40mg／タグリッソ錠80mg 治疗类别名称 抗肿瘤药/酪氨酸激酶抑制剂 欧文商標名 Tagrisso Tablets 一般名： オシメルチニブメシル酸塩（Osimertinib Mesilate）（JAN） 化学名：N-(2-{[2-(Dimethylamino)ethyl](methyl)amino}-4-methoxy-5-{[4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide monomethanesulfonate 構造式： 分子式：C28H33N7O2・CH4O3S 分子量：595.71 性　状： 本产品为白色至黄褐色粉末。 条件批准 1.建立药品风险管理计划的顶部，要正确实施。 2.由于试验病人在日本是非常有限的，上市后，直至有关一定数量的病例数据集成，通过实现对一切案件的使用，结果调查显示，这使得它能够及早发现这种药物的使用患者的背景资料，数据收集这种药物的安全性和有效性，采取必要的措施，正确使用此药。 3.施用这种药物，肺癌的诊断，熟悉化疗，以便仅在原始药房谁是医生，医疗机构和管理药剂师可充分控制也有关此代理人的风险，等，制造和销售进行在采取必要的措施 适应病症 表皮生长因子受体T790M突变阳性的EGFR酪氨酸激酶抑制剂的抗性的不可操作或复发性的非小细胞肺癌。 用法用量 成年人每天给药一次，每次口服为80毫克。应当指出的是，根据该状态的患者减量。 药效药理 作用机序： 本剂不仅活化突变（L858R等），它显示了表皮生长因子受体酪氨酸激酶的抑制效果也有认为抑制肿瘤的与表皮生长因子受体T790M突变生长的T790M突变。 抗肿瘤效果 体外测试： 这种药物是，从H1975（L858R/ T790M）非小细胞肺癌具有从PC9细胞系（Ex19del）非小细胞肺癌（NSCLC），表皮生长因子受体激活与EGFR活化突变和PC9VanR（Ex19del/T790M）细胞突变和T790M突变它抑制了的增长。 体内试验： 此药，非小细胞肺癌从H3255衍生的EGFR活化突变（L858R）和PC9细胞系，以及在裸鼠的H1975和PC9VanR细胞系皮下植入，它显示出肿瘤生长的抑制作用。此外，EGFR活化突变和T790M突变的转基因小鼠中的肺表达显示抑制肿瘤生长。此外，这种药物具有在与PC9细胞系脑和软脑膜管腔注入裸鼠，表示肿瘤增殖抑制效果。 包装规格 片剂 40毫克：[PTP]  28片（7片×4） 80毫克：[PTP]  14片（7片×2） 制造厂商 阿斯利康有限公司 原处方资料附件：http://www.info.pmda.go.jp/go/pack/4291045F1027_1_02/ AstraZeneca lung cancer drug Tagrisso approved by Japan AstraZeneca, a British pharmaceutical giant, has also been approved by Japanese regulators for the new skin cancer drug testrisso (omisertinib, AZD9291), following the approval of the US and European markets in November and February last year. Cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is used to treat resistant EGFR T790M mutations, surgery for incurable or recurrent non-small cell lung cancer (NSCLC). It is estimated that about 30-40% of Asian NSCLC patients carry EGFR mutations at diagnosis, up to 2/3 of patients who have undergone the current treatment of EGFR-TKI have developed a T790M resistance mutation, treatment options are very limited. And Tagrisso will provide an important therapeutic option for such patients, which can simultaneously target EGFR mutations and T790M resistance mutations involved in tumorigenesis, which induces resistance to existing EGFR-TKI drugs. AstraZeneca has teamed up to diagnose giant Roche has developed a cobaseGFR mutant companion diagnostic kit for accurate identification of patients who can benefit from the treatment of Tagrisso. The approval was based on positive top-line data from two multinational AURA Phase II clinical trials (AURA Extended Study, AURA2 study), 22% of which were Japanese lung cancer patients. These studies demonstrate the efficacy and safety of Tagrisso in non-small cell lung cancer (NSLCL) and gene test to confirm EGFR T790M mutant-positive non-small cell lung cancer (NSCLC) during EGFR-TKI treatment or after treatment. In the AURA extended study (n = 199), the overall objective response rate (ORR, tumor shrinkage) reached 61.3% (95% CI: 54.2% -68.1%), the total objective response rate in the AURA2 study (n = 199) 70.9% (95% CI: 64.0% -77.1%) (as of May 1, 2015). Tagrisso is the third generation of EGFR-TKI, designed to overcome the drug resistance to other drugs in the drug, including Roche / Astellas annual sales of 2 billion US dollars of erlotinib, AstraZeneca gefitinib, Boehringer Ingelheim. Tagrisso is the first drug to be marketed for T790M mutant-positive NSCLC for EGFR-TKI treatment or post-treatment progression. Currently, AstraZeneca is conducting the AURA3 Phase III study, which involved EGFR T790M-positive locally advanced or metastatic NSCLC patients with progression after EGFR-TKI treatment, and compared Tagrisso with platinum-containing dual chemotherapy regimens. In addition, AstraZeneca is also investigating Tagrisso as adjuvant therapy and first-line therapy for metastatic NSCLC (including brain metastases), as well as combination therapy with Tagrisso and other drugs. This article Department of pharmacists/medical experts original translation finishing, welcome to reprint! At the same time the procurement of domestic scientific research institutions can contact us: 2363244352.3330889895