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新型口服抗癌药Lenvima（lenvatinib）获欧盟批准上市

2015-06-21 22:53:39 作者：新特药房来源：互联网浏览次数：101 文字大小：【大】【中】【小】

简介： 2015年6月10日,日本药企卫材在英国推出新型口服抗癌药Lenvima（lenvatinib），该药于本月初获欧盟批准，用于进展性、局部晚期或转移性放射性碘难治（RAI）分化型（乳头状/滤泡状/嗜酸细胞）甲状腺癌（DTC ...

关键字：lenvatinib 商品名lenvima 甲状腺癌优先审评孤儿产品

2015年6月10日,日本药企卫材在英国推出新型口服抗癌药Lenvima（lenvatinib），该药于本月初获欧盟批准，用于进展性、局部晚期或转移性放射性碘难治（RAI）分化型（乳头状/滤泡状/嗜酸细胞）甲状腺癌（DTC）成人患者的治疗。
英国也是Lenvima上市的首个欧洲国家，卫材已计划未来几个月陆续在欧洲其他国家推出Lenvima。值得一提的是，Lenvima在监管方面势如破竹，该药自2015年开年已成功拿下美日欧3大主要市场，而且在这3个市场中均被授予孤儿药地位并通过优先审查通道批准。
Lenvima是治疗分化型甲状腺癌的首个分子靶向治疗药物，该药作为一种具有重大公共卫生利益的创新药物，将帮助解决难治性分化型甲状腺癌（DTC）群体中存在的严重未获满足需求。
Lenvatinib的获批，是基于一项III期SELECT研究的积极顶线数据。该研究是一项多中心、随机、双盲、安慰剂对照研究，调查了口服lenvatinib（24mg）治疗放射性碘131抵抗的分化型甲状腺癌(RR-DTC)的疗效。数据表明，与安慰剂相比，lenvatinib使无进展生存期（PFS）得到了统计学意义的显著延长（18.3个月 vs 3.6个月，p＜0.0001）。此外，lenvatinib治疗组有64.8%的患者实现肿瘤缩小（客观缓解），安慰剂组数据仅为1.5%，达到了研究的主要终点。
分化型甲状腺癌（DTC）是最常见的甲状腺恶性肿瘤，约占所有甲状腺癌病例的95%。目前，尽管大多数分化型甲状腺癌可通过手术切除或放射性碘治疗，但一旦恶化鲜有治疗方案，该领域仍存在着严重未获满足的医疗需求。
近年来，甲状腺癌发病率在多个国家和地区呈稳步上升趋势，据美国国家癌症研究所（NCI）数据，2014年美国新增甲状腺癌病例6.3万例；在欧洲，每年新增病例5.2万。
Lenvatinib是一种口服多受体酪氨酸激酶（RTK）抑制剂，具有新颖的结合模式，除抑制参与肿瘤增殖的其他促血管生成和致癌信号通路相关RTK外，还能够选择性抑制血管内皮生长因子（VEGF）受体的激酶活性。目前，卫材也正在评估lenvatinib用于其他类型肿瘤的治疗，包括肝癌、肾细胞癌、非小细胞肺癌等，该药在日本、欧盟及其他国家的监管审查正在进行中
New Drugs Online Report for lenvatinib
Information
Generic Name: lenvatinib
Trade Name: Lenvima
Synonym: E7080
Entry Type: New molecular entity
Development and Regulatory status
UK: Launched
EU: Launched
US: Approved (Licensed)
UK launch Plans: Available only to registered users
Actual UK launch date: June 2015
Comments
Jun 15: Launched in the UK [19].
09/06/2015 17:46:34
Jun 15: Lenvatinib approved in EU for treatment of adults with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine [18].
02/06/2015 12:13:09
Mar 15: EU positive opinion for treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine [17].
27/03/2015 16:24:19
Feb 15: Approved in US [16]
16/02/2015 12:52:00
Oct 14: FDA grants NDA Priority Review status lenvatinib as a treatment for progressive radioactive iodine-refractory differentiated thyroid cancer. A decision is expected by 14 Apr 2015 [14].
16/10/2014 12:14:35
Aug 14: Filed for marketing approval in EU and US for progressive radioiodine-refractory differentiated thyroid cancer [13].
26/08/2014 12:51:08
Jul 14: EMA agrees to undertake an accelerated assessment of lenvatinib as a treatment for progressive radioiodine-refractory, differentiated thyroid cancer. Eisai plan to file imminently [12].
01/08/2014 12:14:12
Feb 14: Filing anticipated 2014 [10].
06/03/2014 10:57:38
May 13: Granted orphan drug status in the EU for treatment of follicular (EU/3/13/1121) & papillary thyroid cancer (EU/3/13/1119) [7].
15/05/2013 11:28:27
Feb 13: Granted orphan drug status in the US [6].
21/02/2013 10:02:16
Aug 11: In PIII global development programme [5].
07/09/2011 13:15:49
Filing anticipated 2013 [4].
13/06/2011 11:29:37
Mar 11: PIII study (NCT01321554 ) started [3].
04/04/2011 16:15:08
PII in the EU & US [1].
02/12/2010 09:34:30
Trial or other data
Feb 15: Eisai present positive data from the PIII SELECT trial, published in the New England Journal of Medicine, which show that lenvatinib improves response rate in 64.8% of people with RR-DTC compared with 1.5% given placebo. Adverse effects were managed with dose reductions and standard interventions, but were greater with lenvatinib, and include six treatment-related deaths [15].
13/02/2015 14:23:38
June 14: Results from the SELECT study presented at 50th ASCO. Primary endpoint, progression-free survival with lenvatinib was extended significantly compared to placebo (HR=0.21, [99% CI: 0.14-0.31]; p<0.0001). The median PFS with lenvatinib and placebo were 18.3 months and 3.6 months, respectively. Secondary endpoints included overall response rate (ORR), overall survival (OS) and safety. The ORR for lenvatinib was significantly increased to 64.8% (95% CI: 59.0-70.5) compared to 1.5% (95% CI: 0.0-3.6; p<0.0001) in the placebo arm. Median OS has not been reached yet. Most common treatment-related AEs were hypertension (67.8%), diarrhoea (59.4%), decreased appetite (50.2%), weight loss (46.4%) and nausea (41%). [11]
03/06/2014 09:24:23
Feb 14: The SELECT (Study of E7080 LEnvatinib in Differentiated Cancer of the Thyroid) study was a multicenter, randomised, double-blind, placebo-controlled Phase 3 study to compare the progression-free survival (PFS) of patients with radioiodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within the prior 12 months, treated with once-daily, oral lenvatinib (24mg) versus placebo. Compared to placebo, lenvatinib showed a highly statistically significant improvement in progression free survival (PFS) in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). [9]
04/02/2014 10:27:04
Mar 11: NCT01321554 is a US multicentre, randomized, double-blind, placebo-controlled, PIII trial of E7080 in 360 patients with 131I-refractory differentiated thyroid cancer. The objective is to compare progression-free survival (PFS) with radiographic evidence of disease progression over 12 months. Subjects with confirmed disease progression while receiving blinded study drug may request to receive open label E7080 [3].
04/04/2011 16:13:49
Aug 09: an open-label PII (NCT00784303) study to determine the safety & efficacy of E7080 in pts with medullary & iodine-131 refractory, unresectable differentiated thyroid cancer began recruitment of 104 pts in the US, France, Germany, Italy, Poland & the UK. Enrolment is complete and the study is estimated to complete data collection in Oct 11 [2].
02/12/2010 09:39:23
References
Available only to registered users
Category
BNF Category: Other antineoplastic drugs (08.01.05)
Pharmacology: Multi-targeted kinase inhibitor of VEGFR1-3, FGFR1-4 & RET tyrosine kinases
Epidemiology: In 2008, 2,154 people were diagnosed with thyroid cancer in the UK (age-standardised incidence rate 3.2 per 100,000 population). Thyroid cancer caused 354 deaths in the UK in 2008. There is a male:female ratio of 1:3. The estimated lifetime risk of developing thyroid cancer in 2008 was 1 in 650 for men and 1 in 243 for women in the UK.
Indication: Thyroid cancer
Additional Details: radioiodine-refractory differentiated cancer
Method(s) of Administration
Oral
Company Information
Name: Eisai
US Name: Eisai
Further Information
Anticipated commissioning route (England) NHSE
High cost drug list? No
Tariff Chemotherapy is locally negotiated.
Implications Available only to registered users