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Tagrisso Tablets(Osimertinib Mesilate)

2016-04-05 07:46:18  作者:新特药房  来源:互联网  浏览次数:7  文字大小:【】【】【
简介: 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 ...

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/42910B4F1025_1_02/
Tagrisso (Osimertinib Tablets)
TAGRISSO™ (osimertinib) receives positive CHMP opinion for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer
AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of TAGRISSO™ (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
This indication includes NSCLC patients whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and patients with a T790M mutation who have not been treated with an EGFR-TKI.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The CHMP’s recommendation for osimertinib to receive marketing approval is a positive step for patients in Europe. This follows the recent US accelerated approval of osimertinib and its adoption in the UK under the Early Access to Medicines Scheme to meet urgent unmet need. Building on the breakthrough clinical evidence, we’re investigating osimertinib’s full potential as a monotherapy and in novel combinations with other precision medicines and immunotherapies from our comprehensive oncology pipeline.”
AURA study clinical investigator Professor Jean-Charles Soria, Head of Drug Development Department, Gustave Roussy Cancer Center, Paris, France added; “In Europe, lung cancer kills over 260,000 people every year, so there is an urgent need for new treatments. As a treating physician, it is very gratifying to see the progression of osimertinib towards use in clinical practice for patients living with EGFRm T790M non-small cell lung cancer.”
Osimertinib is an EGFR-TKI designed to inhibit both the activating, sensitising mutation (EGFRm), and T790M, a genetic mutation responsible for EGFR-TKI treatment resistance. Nearly two-thirds of patients with EGFRm NSCLC whose disease progresses after EGFR-TKI treatment develop the T790M resistance mutation, for which treatment options are limited.
The CHMP recommendation for osimertinib is based on data from two Phase II studies (AURA extension and AURA2) and the AURA Phase I expansion study, which demonstrated efficacy in 474 EGFRm T790M NSCLC patients who had progressed on or after an EGFR-TKI. In the combined Phase II studies, the objective response rate (ORR, a measurement of tumor shrinkage) was 66%, and in the Phase I study it was 62%. Progression-free survival (PFS) was 9.7 months in the combined Phase II studies and 11 months in the Phase I trial. Median duration of response (DOR) in the Phase I study was 9.7 months and in the combined Phase II studies, median duration of response was not reached.
The most common adverse events based on data from the two AURA Phase II studies were generally mild to moderate and included diarrhoea (42% all grades; 1.0% Grade 3/4), rash (41% all grades; 0.5% Grade 3/4), dry skin (31% all grades; 0% Grade 3/4), and nail toxicity (25% all grades; 0% Grade 3/4). Warnings and precautions include interstitial lung disease, QT interval prolongation and embryofoetal toxicity.
The positive CHMP recommendation has been received through the EMA’s Accelerated Assessment and follows the recent US Accelerated Approval of osimertinib by the Food and Drug Administration (FDA). In Japan, osimertinib was granted Priority Review by the Pharmaceuticals and Medical Devices Agency (PMDA). Interactions with regulatory authorities in the rest of the world are ongoing.
NOTES TO EDITORS
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths, and more than breast, prostate and colorectal cancers combined. Patients who have the EGFRm form of NSCLC, which occurs in 10-15 percent of NSCLC patients in Europe and 30-40 percent of NSCLC patients in Asia, are particularly sensitive to treatment with currently available EGFR-TKIs, which block the cell signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to treatment, leading to disease progression. In approximately two-thirds of patients treated with the approved EGFR-TKIs, gefitinib, erlotinib or afatinib, this resistance is caused by the secondary mutation, T790M.
About osimertinib
Osimertinib 80mg once-daily tablet is the first potential medicine indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC. Non-clinical in vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against mutant EGFR phosphorylation across the range of clinically relevant EGFRm and T790M mutant NSCLC cell lines, with significantly less activity against EGFR in wild-type cell lines.
Osimertinib is being compared with platinum-based doublet chemotherapy in the confirmatory AURA3 Phase III study in patients with EGFR T790M-positive, locally advanced, or metastatic NSCLC who have progressed after EGFR-TKI therapy. It is also being investigated in the adjuvant and metastatic first-line settings, including in patients with brain metastases, and in combination with other compounds.
About AstraZeneca in Oncology
Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one day eliminate cancer as a cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.
阿斯利康肺癌新药Tagrisso获日本批准
继去年11月和今年2月获美欧2大市场加速批准之后,英国制药巨头阿斯利康(AstraZeneca)在研肺癌新药Tagrisso(omisertinib,AZD9291)近日也喜获日本监管机构批准,用于对表皮细胞生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗有抵抗的EGFR T790M突变阳性、手术无法治愈的或复发性非小细胞肺癌(NSCLC)的治疗。
据估计,约30-40%的亚洲NSCLC患者在确诊时携带EGFR突变,高达2/3的患者在接受当前已上市EGFR-TKI治疗后病情进展产生T790M耐药突变,治疗选择十分有限。而Tagrisso将为这类患者提供一种重要的治疗选择,该药可同时靶向参与肿瘤发生的EGFR突变及T790M耐药突变,后者使肿瘤对现有EGFR-TKI药物产生抵抗。
阿斯利康已联手诊断巨头罗氏开发了一款cobaseGFR突变伴随诊断试剂盒,用于准确识别可从Tagrisso治疗中受益的患者群体。
此次批准,是基于2项多国AURA II期临床试验(AURA扩展研究,AURA2研究)的积极顶线数据,其中22%的患者为日本肺癌患者。这些研究证明了Tagrisso在接受EGFR-TKI治疗过程中或治疗后病情进展的非小细胞肺癌(NSLCL)以及基因检测证实EGFR T790M突变阳性非小细胞肺癌(NSCLC)中的疗效和安全性。AURA扩展研究(n=199)中,总的客观缓解率(ORR,肿瘤缩小)达到了61.3%(95%CI:54.2%-68.1%),AURA2研究(n=199)中总的客观缓解率为70.9%(95%CI:64.0%-77.1%)(截止2015年5月1日)。
Tagrisso是第三代EGFR-TKI,旨在克服对该类药物中其他药物的耐药性,包括罗氏/安斯泰来年销20亿美元的厄洛替尼、阿斯利康的吉非替尼、勃林格殷格翰的阿法替尼。Tagrisso是首个获批上市用于经EGFR-TKI治疗时或治疗后病情进展的T790M突变阳性NSCLC的药物。
目前,阿斯利康正在开展AURA3 III期研究,该研究涉及经EGFR-TKI治疗后病情进展的EGFR T790M阳性局部晚期或转移性NSCLC患者,研究中将Tagrisso与含铂双重化疗方案进行了对比。此外,阿斯利康也正在调查Tagrisso作为辅助疗法及一线疗法治疗转移性NSCLC(包括脑转移),以及Tagrisso与其他药物的组合疗法。

责任编辑:admin


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