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欧盟认证肾肿瘤药Cabozantinib和Lenvatinib 。
依维莫司 飞尼妥药物摘 要:依维莫司过柱支撑架价钱。欧盟认证肾肿瘤药Cabozantinib和LenvatinibCabozantinib and Lenvatinib for Kidney Cancer Get OK in EU肾肿瘤药Cabozantinib和Lenvatinib得到欧盟认证Patients with kidney cancer in Europe who are not responding to treatment will soon have two new options to try, as cabozantinib (Cabometyx, Ipsen Pharma) and lenvatinib (Kisplyx, Eisai Europe Ltd) have been recommended for approval by the European Medicines Agency (EMA).对医治初始化失败的欧洲地区肾肿瘤病患者,将要有二种新的挑选可以试着。这是由于cabozantinib (Cabometyx, Ipsen Pharma) 和lenvatinib (Kisplyx, Eisai Europe Ltd)得到了欧洲地区药品局(EMA)的准许。Both of these drugs are tyrosine kinase inhibitors, and both are recommended for use in patients with kidney cancer who have been previously treated with a vascular endothelial growth factor (VEGF) inhibitor. Cabozantinib is to be used as monotherapy, whereas lenvatinib is to be used in combination with everolimus (Afinitor, Novartis).这2种药均为络酪氨酸蛋白激酶缓聚剂,二者均强烈推荐用以的此前接纳过毛细血管内皮细胞细胞生长因子(VEGF)缓聚剂医治的肾肿瘤病患者。Cabozantinib用以单一医治,而lenvatinib必须与依维莫司(飞尼妥,诺华制药)协同应用药。The drugs are already approved for this indication in the United States.药品的融入症状早就在国外得到准许。In its announcement, the EMA notes that the most common form of kidney cancer in adults is renal cell carcinoma (RCC). Advanced RCC includes both metastatic disease and locally advanced disease that cannot be removed by surgery. Despite the recent approval of new therapies for advanced RCC, many patients who do not respond to the existing treatments have a poor prognosis. Therefore, new treatment options are needed, the agency comments.在它的详细说明中,EMA注意到成年人最普遍的肾肿瘤类型为肾细胞癌(RCC)。晚中后期的RCC包含迁移扩散性病症和不可以根据手术清除的部分晚中后期病症。无论近期刚得到许可的晚中后期RCC的新治治疗方法如何,大部分针对已经开展的医治无响应的病患者都具有不好的愈后。因此 ,新的诊治挑选是必需的,有组织这般评价【 手机微信:yaodaoyaofang】道。The EMA considers the kidney cancer indications for cabozantinib and lenvatinib to be accelerated approvals because both drugs were felt to address an unmet medical need.EMA充分考虑cabozantinib and lenvatinib的融入症状是偏向肾肿瘤的,因此 对其完成了加快审核。这是由于,这2种药可以处理一个未被考虑的医疗服务要求。The EMA also notes that both of these drugs are also used in thyroid cancer but are marketed for that indication under different trade names. Cabozantinib (as Cometriq) was approved in the EU in December 2013 for adults with medullary thyroid cancer, while lenvatinib (as Lenvima) was recommended for approval for patients with thyroid carcinoma in March 2015.EMA也留意到,这两类药品也都可以用以甲状腺癌症。可是在品牌推广中,不一样的融入症状应用不一样的商品名。Cabozantinib (商品名 Cometriq)于2013年12月得到EU准许,用以医治成年人甲状腺囊肿髓样癌。而lenvatinib (商品名Lenvima欧盟认证肾肿瘤药Cabozantinib和Lenvatinib)于2015年3月提议准许用以甲状腺癌症的病患者。Clinical Data to Support Approval适用准许的临床数据Cabozantinib was recommended for approval mainly on the basis of a phase 3 trial (known as METEOR) involving 658 patients with metastatic RCC that had progressed after prior VEGF receptor tyrosine kinase inhibitor therapy. As previously reported by Medscape Medical News, this study showed the longest progression-free survival (PFS) ever seen in t欧盟认证肾肿瘤药Cabozantinib和Lenvatinibhis setting, with 7.4 months on cabozantinib compared with 3.8 months on everolimus, which is the usual standard second-line therapy. In addition, preliminary results show an improved overall survival, with a median of 21.4 months on cabozantinib vs 16.5 months on everolimus.Cabozantinib可以提议准许,主要是根据它的3期临床试验(称之为METEOR)。有658名在此前VEGF蛋白激酶络酪氨酸蛋白激酶缓聚剂医治后发展趋势的迁移扩散性RCC病患者参加在其中。像此前Medscape Medical News报导中讲到的,在该类设定中,此次科学研究体现出了最多的无进度存活時间(PFS),Cabozantinib组为7.4个月,依维莫司组为3.8个月。在其中,依维莫司一般作为规范二线医治。此外,其基本結果也体现出了对总生存数的提升 ,Cabozantinib组的平均数为21.4个月,而依维莫司组的为16.5个月。The EMA notes that the most frequent adverse reactions associated with cabozantinib include diarrhea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysesthesia syndrome (hand and foot redness, swelling, and pain), hypertension, and vomiting.EMA也注意到,与cabozantinib有关的最经常出現的副作用包含拉肚子,疲倦,恶心想吐,胃口降低,掌跖觉得缺失性红疹子综合症(手和脚泛红、瘙痒、痛楚),血压高,和恶心呕吐。Lenvatinib was recommended for approval mainly on the basis of a phase 1b/2 trial involving 153 patients with metastatic or unresectable RCC who received at least one prior VEGF targeted therapy and were treated with lenvatinib plus everolimus or with one of these agents used alone. In this study, progression-free survival was 12.8 months on average for patients receiving the combination of lenvatinib and everolimus, compared with 5.6 months for patients treated with everolimus alone, based on independent review of radiologic images. In addition, encouraging signs of prolonged overall survival were seen in patients given the combination therapy.Lenvatinib可以提议准许,主要是根据其1b/2期的临床试验。有153名此前最少进行过一次VEGF靶向药物治疗的迁移扩散性或不能摘除的RCC病患者参加在其中,应用Lenvatinib和依维莫司开展医治,或是只应用在其中一种药品开展独立医治。在此项探究中,协同应用Lenvatinib和依维莫司医治的病患者均值无进度生存的时间为12.八个月,而只应用依维莫司开展医治的病患者仅有5.6个月,根据放射学影象的单独查验。此外,针对开展协同诊治的病患者,在总生存数的提升层面,有让人高兴的征兆。The most frequent adverse reactions include diarrhea, fatigue, decreased appetite, vomiting, nausea, and hypertension. Severe diarrhea occurred at a higher frequency in the combination group than in the everolimus group.最普遍的不良反应包含拉肚子,疲倦,胃口降低,恶心呕吐,恶心想吐,和血压高。比较严重的拉肚子在协同应用药组的发病率高过依维莫司组。When assessing these data, the EMA\'s Committee for Medicinal Products for Human Use considered that the benefits of lenvatinib plus everolimus outweigh its risks but requested that postauthorization studies be conducted to collect further data to complement data from the phase 1b/2 trial.在评定这种数据信息时,EMA人买医科学研究商品联合会充分考虑lenvatinib和依维莫司的获利胜于它的风险,可是一样规定必须开展批准后科学研究,以搜集大量的信息健全1b/2期的临床试验中的数据信息。之上文章内容来自于【微信号码:yaodaoyaofang】【微信号码:yaodaoyaofang】:英度国际性。大量相关的新闻资讯,请【关心大家请加微信好友:yaodaoyaofang 】【微信号码:yaodaoyaofang】【微信号码:yaodaoyaofang】:英度国际性。
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