卫材在美国推出新型抗癌药Lenvima，用于碘难治分化型甲状腺癌（DTC）治疗

2015年3月4日讯/生物谷BIOON/--日本药企卫材（Eisai）近日宣布，在美国推出其自主研发的新型抗癌药Lenvima（lenvatinib），该药于今年2月初获FDA批准用于放射性碘难治性分化型甲状腺癌（RR-DTC）患者的治疗。在美国、日本、欧盟3大主要市场，lenvatinib均被授予孤儿药地位，并通过FDA的优先审查通道获批。Lenvima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满足的医疗需求。业界预测，Lenvima将成为卫材新的摇钱树，年销售峰值将突破10亿美元。
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vs3.6个月，p＜0.0001），此外lenvatinib治疗组有65%的患者肿瘤缩小，安慰剂组数据仅为2%，达到了研究的主要终点。
目前，尽管大多数类型的甲状腺癌能够治疗，而一旦恶化鲜有治疗方案可供选择。分化型甲状腺癌（DTC）是最常见的甲状腺恶性肿瘤，近年来发病率稳步上升。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，有1890例患者死亡。
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。
英文原文：EISAILAUNCHESANTICANCERAGENTLENVIMA™INTHEUNITEDSTATES
FIRSTCOUNTRYINTHEWORLDTOGAINACCESSTONEWTREATMENTOPTION
EisaiCo.,Ltd.(Headquarters:Tokyo,CEO:HaruoNaito,“Eisai”)announcedtodaythatitsU.S.subsidiaryEisaiInc.haslauncheditsin-housedevelopednovelanticanceragentLenvima™(lenvatinibmesylate)asatreatmentforlocallyrecurrentormetastatic,progressive,radioactiveiodine-refractorydifferentiatedthyroidcancerintheUnitedStatesonFebruary26,2015.TheUnitedStatesisthefirstcountryintheworldwheretheagenthasbeenlaunched.
DiscoveredatEisaisTsukubaResearchLaboratoriesanddevelopedin-house,LenvimaisanorallyadministeredmoleculartargetedagentthatselectivelyinhibitstheactivitiesofseveraldifferentmoleculesincludingVEGFR,FGFR,RET,KITandPDGFR.Inparticular,theagentsimultaneouslyinhibitsVEGFR,FGFRandalsoRETwhichareespeciallyinvolvedintumorangiogenesisandproliferationofthyroidcancer.Furthermore,LenvimahasbeenconfirmedthroughX-raycrystalstructuralanalysistodemonstrateanewbindingmode(TypeV)toVEGFR2,andexhibitsrapidandpotentinhibitionofkinaseactivity,accordingtokineticanalysis1.InaPhaseIIIplacebocontrolledstudy(SELECTstudy),Lenvimademonstratedastatisticallysignificantimprovementinprogression-freesurvivalcomparedtoplaceboaswellasresponserate.ThefivemostcommonLenvimatreatment-relatedadverseeventsofanygradewerehypertension,diarrhea,fatigueorasthenia,decreasedappetite,andweightloss.LenvimawasapprovedintheUnitedStatesbytheU.S.FoodandDrugAdministration(FDA)onFebruary13,2015,basedontheFDAspriorityreviewsystem.
Althoughtreatmentispossibleformosttypesofthyroidcancer,therearefewtreatmentoptionsavailableoncethyroidcancerhasprogressed,thereforeitremainsadiseasewithsignificantunmetmedicalneeds.Thenumberofpatientsnewlydiagnosedwiththyroidcancerin2012intheUnitedStateswasestimatedtobeapproximately52,000.
CurrentlytheagentisundergoingregulatoryreviewinJapanandtheEU,aswellasSwitzerland,SouthKorea,Canada,Singapore,Russia,AustraliaandBrazil,andLenvimawasalsograntedacceleratedassessmentintheEU.Eisaiwillcontinuetofileapplicationsseekingregulatoryapprovalfortheagentincountriesaroundtheworld,andthecompanywillmarkettheagentinthosecountrieswhereapprovalhasbeenreceived.Furthermore,EisaiisconductingaglobalPhaseIIItrialofLenvimainhepatocellularcarcinomaaswellasPhaseIIstudiesofLenvimainseveralothertumortypessuchasrenalcellcarcinomaandnon-smallcelllungcancer.
InadditiontoprovidingLenvimaasanewtreatmentoptionforthyroidcancer,EisaiiscommittedtoexploringthepotentialclinicalbenefitsofLenvimainordertofurthercontributetoaddressthediverseneedsof,aswellasincreasethebenefitsprovidedto,patientswithcancer,andtheirfamilies.
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