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欧美加速审批——卫材甲状腺癌新药lenvatinib收获在望

  1. lenvatinib
  2. 卫材
  3. 甲状腺癌
  4. 酪氨酸激酶抑制剂

来源:生物谷 2014-10-17 09:26

日欧美3大市场均授予lenvatinib孤儿药地位,欧美还授予加速审查和优先审查资格,最快预计在2015年4月获批。

2014年10月17日讯 /生物谷BIOON/ --导读:lenvatinib在日欧美3大市场均授予孤儿药地位,并且获欧美2大市场加速审查和优先审查资格。目前,卫材深陷重磅产品专利悬崖重创,lenvatinib已成为该公司恢复增长的最佳希望。

卫材(Eisai)近日宣布,FDA已接受审查抗癌药lenvatinib新药申请(NDA)并已授予优先审查资格。此外,FDA已指定该药NDA处方药用户收费法(PDUFA)目标日期为2015年4月14日,距离卫材提交NDA为8个月。此前,卫材已向日本、欧盟、美国提交lenvatinib上市申请,寻求批准用于放射性碘难治性分化型甲状腺癌(RR-DTC)的治疗。在日欧美3大市场,lenvatinib均被授予孤儿药地位。此外,欧盟已授予lenvatinib加速审评资格。从治疗创新的角度思考,lenvatinib将成为一种具有重大公共卫生利益的新药。

优先审查资格意味着FDA将在6个月内完成上市申请的审查,而不是标准的10个月审查期。FDA的优先审评资格(Priority Review designation),通常只授予那些治疗严重病症,或与现有治疗药物相比可为严重疾病的治疗、诊断或预防的安全性及疗法方面提供明显改善的药物。

目前,卫材仍然深陷于阿尔茨海默氏症重磅药物Aricept(多奈哌齐)专利到期所带来的重创。Aricept属于第二代中枢性乙酰胆碱酯酶抑制剂,是全球抗老年痴呆症药物市场的领军品种,曾连续数年销售额突破30亿美元,自2010年11月专利到期后,受仿制药冲击,销售额呈断崖式下跌。而卫材也一直在努力尝试从Aricept仿制药重创中恢复,但却接连受挫。

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用于其他癌症的治疗。

Lenvatinib在日本、美国、欧盟提交的申请文件,是基于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III期研究,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,主要终点为无进展生存期(PFS),次要终点包括总缓解率(ORR),总生存期(OS)和安全性。数据表明,与安慰剂组相比,lenvatinib治疗组无进展生存期(PFS)显著延长(18.3个月 vs 3.6个月,p<0.0001),达到了研究的主要终点。

据估计,在美国,2012年新增甲状腺癌患者5.2万例。目前,尽管大多数类型的甲状腺癌能够治疗,但复发性甲状腺癌鲜有治疗方案,因此存在显著未获满足的医疗需求。(生物谷Bioon.com)

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英文原文:U.S. FDA Grants Priority Review Status to NDA for Anticancer Agent Lenvatinib

Tokyo, Oct 15, 2014 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) submitted by its U.S. subsidiary Eisai Inc. for its novel in-house developed anticancer agent lenvatinib mesylate (lenvatinib) as a treatment for progressive radioiodine-refractory differentiated thyroid cancer and granted the NDA Priority Review status.

The FDA's Priority Review designation is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) for lenvatinib of April 14, 2015, eight months after the NDA was submitted.

Applications for marketing authorization approval of lenvatinib were submitted in Japan for the indication of thyroid cancer in June 2014 and in Europe and the U.S. for the indication of progressive, radioiodine-refractory differentiated thyroid cancer in August 2014. Lenvatinib was granted Orphan Drug Designation for thyroid cancer in Japan, Europe and the U.S. Lenvatinib was also granted an accelerated assessment by the European regulatory authority, as it is a new medicine expected to be of major public health interest, particularly from the viewpoint of therapeutic innovation.

Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of several different RTKs including VEGFR, FGFR, PDGFRalpha, KIT and RET, involved in angiogenesis and tumor proliferation. This potentially makes lenvatinib a first-in-class treatment in thyroid cancer, especially given that it simultaneously inhibits the kinase activities of FGFR as well as VEGFR.

The number of patients newly diagnosed with thyroid cancer in 2012 in the U.S. was estimated to be approximately 52,000. Although treatment is possible for most types of thyroid cancer, there are very few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs.

Eisai is committed to exploring the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer, including patients with thyroid cancer, and their families.

About Lenvatinib (E7080)

Lenvatinib, discovered and developed by Eisai, is an oral multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1 (FLT1), VEGFR2 (KDR) and VEGFR3 (FLT4)), in addition to other proangiogenic and oncogenic pathway-related RTKs (including fibroblast growth factor (FGF) receptors FGFR1, 2, 3 and 4; the platelet-derived growth factor (PDGF) receptor PDGFR¦Á; KIT; and RET) involved in tumor proliferation. This potentially makes lenvatinib a first-in-class treatment in thyroid cancer, especially given that it simultaneously inhibits the kinase activities of FGFR as well as VEGFR. An application seeking marketing approval of lenvatinib for the indication of thyroid cancer was submitted in Japan on June 26, 2014. Lenvatinib was granted Orphan Drug Designation in Japan for thyroid cancer in August 2012, in the United States for the treatment of follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer in December 2012, and in Europe for follicular and papillary thyroid cancer in April 2013. It is currently under development as a potential treatment for hepatocellular carcinoma (Phase III), non-small cell lung cancer (Phase II) and other solid tumor types.

About the Phase III Clinical Trial (SELECT Trial)

The SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) trial was a multicenter, randomized, double-blind, placebo-controlled Phase III study of lenvatinib in patients with radioiodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within the prior 13 months (patients may have received ¡Ü1 prior VEGFR-targeted therapies). Patients were randomized 2:1 to either receive once-daily, oral lenvatinib (24 mg) or placebo therapy. The study enrolled 392 patients in over 100 sites in Europe, North and South America and Asia (including Japan) and was conducted by Eisai in collaboration with SFJ Pharma Ltd.

Compared to placebo, lenvatinib achieved a statistically significant improvement (Hazard Ratio (HR) 0.21; 99% CI: 0.14-0.31; p

About Thyroid Cancer

Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea. It is more common in women than in men. The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer and account for approximately 95% of all cases. The remaining cases are classified as either undifferentiated (3-5% of cases) or medullary carcinoma (1-2% of cases). While most differentiated thyroid cancer patients are curable with surgery and radioactive iodine treatment, a small percentage of patients do not respond to therapy.

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