罗拉替尼,罗拉替尼片ローブレナ錠 lorlatinib(Lorbrena Tablets 100mg)

药店国别:

产地国家:日本

处方药:

所属类别: 100毫克/片 10片/盒

包装规格: 100毫克/片 10片/盒

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Pfizer Inc

原产地英文商品名:Lorbrena(ローブレナ錠)100mg/Tablets 10Tablets/box

原产地英文药品名:Lorlatinib

中文参考商品译名:Lorbrena(ローブレナ錠)100毫克/片 10片/盒

中文参考药品译名:罗拉替尼

曾用名:

简介

部份中文罗拉替尼处方资料(仅供参考)

英文名:Lorlatinib

商标名:LORBRENA

中文名:罗拉替尼片

生产商:辉瑞公司

药品介绍

近日,日本批准辉瑞制药有限公司的第三代ALK抑制剂Lorlatinib(商品名:LORBRENA)上市,适用于对ALK抑制剂治疗后进展或不能耐受,间变性淋巴瘤激酶(ALK)阳性的局部晚期或转移性非小细胞肺癌患者的治疗。

药效分类名:抗恶性肿瘤剂/奇形酶阻碍剂

批准日期:2018年9月

商标名:LORBRENA Tablets

一般名:ロルラチニブ(Lorlatinib)

化学名:(10R)-7-Amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-4,8-methenopyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecine-3-carbonitrile

分子式:C21H19FN6O2

分子量:406.41

性状:白色的粉末。易溶于N,N -氧化乙醇,容易溶于乙醇(99.5),有点难溶于甲醇,很难溶于水。分配系数(log P)2.45(pH9、1 -甲醇/水)

批准条件

1 .在制定医药品风险管理计划的基础上,适当地实施。

2早期收集剂的安全性及有效性的数据,以合理使用本剂的适当措施。

3 .本剂是根据肺癌的诊断、精通化学疗法的医生进行的处方的同时,关于本剂的风险等充分管理·说明的医疗机关和药店只被处理,在制造销售时讲必要的措施。

药效药理

1 .抗瘤作用罗尔拉奇尼布对现有的ALK奇形酶阻碍剂(克索索奇尼克、过敏性和丝丝)有耐性的L1196M、G1269A、I1171T以及G1202R变异的ALK融合蛋白的人非小细胞肺癌的NP-H3122细在皮下细胞中,在皮下移植的裸体鼠标中,将细胞股和鼠标线维芽细胞产生的NIH3T3细胞股进行了抑制肿瘤增殖。

2 .作用机序由于罗尔拉奇尼布阻碍了ALK融合蛋白的肉末酶活性,可以认为抑制肿瘤的增殖。适应症ALK聚氨酸激酶阻碍剂的抵抗性或不耐容的ALK融合基因阳性不能切除的进行·再次发生的非小细胞肺癌。

用法与用量

通常,成人的话,一天一次给100毫克。另外,根据患者的状态适当减少。临床成绩国际共同第I/II相测试ALK融合基因阳性或ROS1融合基因阳性的不能切除的进行·复发的非小细胞肺癌患者为对象的第I/II相测试的第II相部中,具有1个收银员以上的ALK奇形酶障碍剂的治疗经历的ALK融合基因阳性非小细胞肺癌患者197例(其中日本人31例)的独立图像评价委员会的演奏率(主要评价项目)为47.2%(95%信任区间:40.1%,54.4%)。关于本剂的生存期等的考试成绩没有得到。

包装:片25mg:40片(10片×4 PTP)100mg:10片(10片×1 PTP)

制造销售:(进口)辉瑞制药有限公司

注:以上中文处方资料不够完整,使用者以原处方资料为准。

英文版说明

ALKPfizer Co, Lt.has the efficacy and efficacy of an anti tumor agent/ tyrosine kinase inhibitor "robe Lena (R) tablet 25mg", which is effective for the non K-cell kinase inhibitor, which is resistant to ALK tyrosine kinase inhibitor, which is resistant or resistant to ALK fusion It has announced that it has released 100 mg of this.The ALK inhibitor of the ALK fusion gene positive has been put on sale after the release of "zarkake (R)" in 2012, and the treatment option has spread in the total of three ALK inhibitors. On the other hand, there is a problem in the treatment that the effect is not obtained by the existing drug by the resistance mutation of the gene.Roth Lena is the third generation ALK inhibitor, which has been focused on this resistance mechanism, and is a drug which is expected to be effective for mutant ALK with resistance mutation.Clinically significant antitumor effects and tolerability of ALK positive NSCLC against resistant or uninhibited ALK inhibitors were shown in clinical trials.Drug approved for conditional early approval systemRoy Lena received the approval of Japan ahead of the world on September 21 after the examination period of about 8 months as an object of the priority examination under the application of "the conditional early approval system of the medicine" introduced in October last year. In the United States, the United States Food and Drug Administration (FDA) was designated as a landmark therapy (Blake thru therapy) and priority screening, and approved on November 2, 2018.The third phase cloud test (NCT 03052608) is currently under way. In this study, the facilities in Japan are also participating in the non blind test group comparison test comparing robe Lena as the first-line treatment for ALK positive metastatic NSCLC to the sarkake.Robe LenaRobe Lena tablets 25mg/100mg (lorbreena tablets 25mg/100mg)LorlatinibNon small cell lung cancer with unresectable or recurrent ALK fusion geneDosage and dosage: normally, an adult is administered 100mg per day as a loratrainib. The patient is appropriately reduced according to the patient's condition.Sales and sales approval approval date: September 21, 2018Manufacturer: fizer Corporation

 

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