欧盟批准安进单抗Vectibix用于结直肠癌一线治疗

2015年4月6日讯/生物谷BIOON/--制药巨头安进（Amgen）近日宣布，欧盟委员会（EC）已批准单抗药物Vectibix（帕尼单抗，panitumumab）联合FOLFIRI化疗，用于野生型（WT）RAS转移性结直肠癌（mCRC）成人患者的一线治疗。据估计，大约有一半的mCRC患者其肿瘤状态为WTRAS。FOLFIRI是一种基于伊立替康（irinotecan）的化疗方案，在欧洲常用于结直肠癌的一线治疗。此次Vectibix新适应症的获批，意味着欧洲的WTRASmCRC患者有了一个重要的治疗选择。
在欧洲，结直肠癌（colorectalcancer）是第二大最常见癌症，每年新增病例数高达47万，该病也是第二大癌症死亡病因，约占所有癌症死亡病例的12%。Vectibix是FDA批准的首个全人源化抗EGFR单克隆抗体，靶向表皮生长因子受体（EGFR），Vectibix能够结合癌细胞表面的EGFR，阻止其与表皮生长因子（EGF）或转化生长因子-α（TGF-α）结合，从而阻断癌细胞生长并缩小肿瘤体积。
此次Vectibix新适应症的获批，是基于在Vectibix联合FOLFIRI在一线治疗中的疗效和安全性数据。
在欧盟，Vectibix的适应症为WT-RASmCRC成人患者：（1）联合FOLFOX或FOLFIRI化疗用于患者的一线治疗；（2）联合FOLFIRI用于既往已接受一线含氟尿嘧啶化疗方案（伊立替康除外）治疗失败的患者的二线治疗；（3）作为一种单药疗法，用于含氟尿嘧啶、奥沙利铂和伊立替康化疗方案治疗失败的患者。
在美国，Vectibix的适应症为WT-KRAS（外显子2）mCRC成人患者：（1）联合FOLFOX（一种基于奥沙利铂的化疗方案）用于一线治疗；（2）作为一种单药疗法，用于含氟尿嘧啶、奥沙利铂和伊立替康化疗方案治疗失败的患者。Vectibix不适用于RAS突变mCRC或RAS突变状态不明的患者。
英文原文：EuropeanCommissionApprovesAmgensVectibix®(panitumumab)AsFirst-LineTreatmentInCombinationWithFOLFIRIChemotherapyForMetastaticColorectalCancer
ImportantStepTowardsIncreasingTreatmentOptionsforPatientsWithThisSeriousDisease
THOUSANDOAKS,Calif.,April6,2015/PRNewswire/--Amgen(NASDAQ:AMGN)todayannouncedthattheEuropeanCommissionapprovedanewuseofVectibix®(panitumumab)asfirst-linetreatmentincombinationwithFOLFIRIforthetreatmentofadultpatientswithwild-type(WT)RASmetastaticcolorectalcancer(mCRC).AbouthalfofthepatientswithmCRChaveWTRAStumors.1FOLFIRI,anirinotecan-basedchemotherapyregimen,isfrequentlyusedinfirst-linecolorectalcancertreatmentinEurope.
"ColorectalcanceristhesecondmostcommoncancerinEurope,andadditionaltreatmentoptionsareimportantforpatientsandforphysicianstreatingthisseriousdisease,"saidElliottM.Levy,M.D.,seniorvicepresidentofGlobalDevelopmentatAmgen."TheEuropeanCommissionapprovalofVectibixasafirst-linetreatmentincombinationwithFOLFIRIchemotherapymeansphysicianshaveanothertreatmentoptionforadultpatientswithwild-typeRASmetastaticcolorectalcancer."
ThenewindicationisbaseduponstudiesthatevaluatedVectibixplusFOLFIRIinthefirst-linesetting.VectibixisnowapprovedintheEuropeanUnion(EU)forthetreatmentofadultpatientswithWTRASmCRC:infirst-lineincombinationwithFOLFOXorFOLFIRI;insecond-lineincombinationwithFOLFIRIforpatientswhohavereceivedfirst-linefluoropyrimidine-basedchemotherapy(excludingirinotecan);andasmonotherapyafterfailureoffluoropyrimidine-,oxaliplatin-,andirinotecan-containingchemotherapyregimens.1
Colorectalcanceristhethirdmostcommoncancerworldwide,withapproximately1.2millioncasesexpectedtooccurglobally.2,3ColorectalcanceristhesecondmostcommoncancerinEurope,withapproximately470,000newcaseseachyear;4thehighestincidencerateofcolorectalcancerintheworld.ItisalsothesecondgreatestcauseofcancerdeathinEuropefollowinglungcancer,accountingfor12percentofallcancerdeaths.3
AboutVectibix®(panitumumab)IntheEU,Vectibixiscurrentlyindicatedforthetreatmentofadultpatientswithwild-typeRASmCRC:
infirst-lineincombinationwithFOLFOXandFOLFIRI.insecond-lineincombinationwithFOLFIRIforpatientswhohavereceivedfirst-linefluoropyrimidine-basedchemotherapy(excludingirinotecan).asmonotherapyafterfailureoffluoropyrimidine-,oxaliplatin-,andirinotecan-containingchemotherapyregimens.ImportantEUProductSafetyInformationDermatologicrelatedreactions,apharmacologiceffectobservedwithepidermalgrowthfactorreceptor(EGFr)inhibitors,areexperiencedwithnearlyallpatients(approximately90percent)treatedwithVectibix.Themajorityofdermatologicalreactionsaremildtomoderateinnature.Inclinicalstudies,subsequenttothedevelopmentofseveredermatologicalreactions(includingstomatitis),infectiouscomplicationsincludingsepsis,inrarecasesleadingtodeath,andlocalabscessesrequiringincisionsanddrainagewerereported.PatientswhohaveseveredermatologicreactionsorwhodevelopworseningreactionswhilstreceivingVectibixshouldbemonitoredforthedevelopmentofinflammatoryorinfectioussequelae,andappropriatetreatmentpromptlyinitiated.
ImportantU.S.ProductInformationVectibixisindicatedforthetreatmentofpatientswithwild-typeKRAS(exon2incodons12or13)metastaticcolorectalcancer(mCRC)asdeterminedbyanFDA-approvedtestforthisuse:
Asfirst-linetherapyincombinationwithFOLFOXAsmonotherapyfollowingdiseaseprogressionafterpriortreatmentwithfluoropyrimidine-,oxaliplatin-,andirinotecan-containingchemotherapyLimitationofUse:VectibixisnotindicatedforthetreatmentofpatientswithRAS-mutantmCRCorforwhomRASmutationstatusisunknown.
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