卫材（Eisai）8月18日宣布，已分别向美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）提交了抗癌药lenvatinib的监管文件，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。此前，卫材已于今年6月向日本劳动卫生福利部（MHLW）提交了lenvatinib的监管申请。在日本、美国、欧盟，lenvatinib均被授予孤儿药地位；同时，EMA已授予lenvatinib加速评估资格。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。
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。尽管卫材对在日、欧、美提交lenvatinib上市申请欢呼不已，但同时也对德国监管部门对其癫痫药物Fycompa的唾弃表达了强烈愤慨。而在美国，卫材最近已对FDA提起诉讼，控告FDA在公司尚未最终敲定Fycompa和减肥药Belviq药物标签之前，便开始了5年独占期的计时。就在几天前，卫材还被迫公布非小细胞肺癌（NSCLC）药物eribulin一项III期研究失败。
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selec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。（生物谷Bioon.com）
英文原文：Struggling Eisai files its thyroid cancer drug lenvatinib in U.S., EU
Still suffering from the loss of patent protection on its big Alzheimer's drug Aricept, Japan's Eisai said today that the company had fired off a pair of applications for its new cancer drug to U.S. as well as European regulators.
Eisai is seeking to gain approvals in both markets to sell lenvatinib for a certain type of thyroid cancer after registering positive progression-free survival data in a late-stage study funded by SFJ Pharma, which is pursuing a novel approach to partnering on late-stage therapies.
Back in March the Tokyo-based pharma said that lenvatinib--a tyrosine kinase receptor (TKR) inhibitor--had hit the primary endpoint in the selec study. And the company is seeking an approval for progressive radioiodine-refractory differentiated thyroid cancer.
That news is a solid plus for SFJ Pharma, a startup trial operation that funded the study under a new development model hatched back in 2011. SFJ fronted the cash for the study in exchange for a set of milestones for a successful outcome of the study, which was conducted by Eisai. This new model for drug development that has attracted attention at Pfizer and other pharma operations looking to spread the risk and cost of R&D.
Eisai says it has several other Phase III and Phase II studies of the drug underway in other tumor types. The company earlier reported plans to get the drug made at one of its U.K. facilities.
Eisai has experienced several setbacks in its quest to recover from the loss of Aricept. While it heralded new applications for lenvatinib, the company was also expressing its outrage at once again seeing its epilepsy drug Fycompa spurned by German regulators, who see it as nothing special compared to therapies already on the market. Germany has a tough new set of regulations in place that demand to see clear evidence of superiority in a new drug before the country will agree to pay a premium for it.
In the U.S., Eisai filed suit against the FDA recently complaining that the agency started the clock ticking on its 5-year exclusivity period for Fycompa and the weight-loss drug Belviq well before it had the drug labels finalized. And a few days ago the company was forced to report that its non-small cell cancer drug eribulin failed a Phase III study.
Eisai also announced a licensing deal today for one of its in-house proton pump inhibitors, granting Zeria Pharmaceutical the right to co-develop and market the therapy in Japan.
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