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【置顶】肾癌药Cabozantinib和Lenvatinib获得欧盟认证

2016-08-03 00:00


Cabozantinib and Lenvatinib for Kidney Cancer Get OK in EU
肾癌药Cabozantinib和Lenvatinib获得欧盟认证


 

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).
对治疗没有响应的欧洲肾癌患者,即将有两种新的选择可以尝试。这是因为cabozantinib (Cabometyx, Ipsen Pharma) 和lenvatinib (Kisplyx, Eisai Europe Ltd)获得了欧洲药品局(EMA)的批准。

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).
这两种药均为络氨酸激酶抑制剂,两者均推荐用于的先前接受过血管内皮生长因子(VEGF)抑制剂治疗的肾癌患者。Cabozantinib用于单一治疗,而lenvatinib需要与依维莫司(飞尼妥,诺华)联合用药。

The drugs are already approved for this indication in the United States.
药物的适应症早已在美国获得批准。

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.
在它的说明中,EMA注意到成人最常见的肾癌类型为肾细胞癌(RCC)。晚期的RCC包括转移性疾病和不能通过手术移除的局部晚期疾病。不管最近刚刚获批的晚期RCC的新治疗法如何,大多数对于正在进行的治疗无响应的患者都有着不良的预后。所以,新的治疗选择是必须的,有机构如此评论道。

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考虑到cabozantinib and lenvatinib的适应症是指向肾癌的,所以对其进行了加速审批。这是因为,这两种药能够解决一个未被满足的医疗需求。

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也注意到了,这两种药物也都可以用于甲状腺癌。但是在市场推广中,不同的适应症使用不同的商品名。Cabozantinib (商品名 Cometriq)于2013年12月获得EU批准,用于治疗成人甲状腺髓样癌。而lenvatinib (商品名Lenvima)于2015年3月建议批准用于甲状腺癌的患者。

Clinical Data to Support Approval
支持批准的临床数据

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 this 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能够建议批准,主要是基于它的3期临床试验(被称作METEOR)。有658名在先前VEGF受体络氨酸激酶抑制剂治疗后发展的转移性RCC患者参与其中。像先前Medscape Medical News报道中说道的,在此类设置中,这次研究表现出了最长的无进展生存期(PFS),Cabozantinib组为7.4个月,依维莫司组为3.8个月。其中,依维莫司通常用作标准二线治疗。另外,其初步结果也表现出了对总存活数的提高,Cabozantinib组的中位数为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相关的最常出现的不良反应包括腹泻,疲乏,恶心,食欲降低,掌跖感觉丧失性红斑综合征(手脚发红、发痒、疼痛),高血压,和呕吐。

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能够建议批准,主要是基于其1b/2期的临床试验。有153名先前至少接受过一次VEGF靶向治疗的转移性或不可切除的RCC患者参与其中,使用Lenvatinib和依维莫司进行治疗,或者只使用其中一种药物进行单独治疗。在这项研究中,联用Lenvatinib和依维莫司治疗的患者平均无进展存活期为12.8个月,而只使用依维莫司进行治疗的患者只有5.6个月,基于放射学影像的独立检查。另外,对于进行联合治疗的患者,在总存活数的延长方面,有令人欣喜的迹象。

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.
最常见的副反应包括腹泻,疲乏,食欲降低,呕吐,恶心,和高血压。严重的腹泻在联合用药组的发生率高于依维莫司组。

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.
在评估这些数据时,EMA人用医学产品委员会考虑到lenvatinib和依维莫司的获益胜过它的风险,但是同样要求需要进行获准后研究,以收集更多的数据完善1b/2期的临床试验中的数据。




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