开年大吉，罗氏、Exelixis黑色素瘤药物距获批仅一步之遥

2015年2月22日讯/生物谷BIOON/--所谓行百里者半九十。审批过程对于所有上市药品来说都是最重要的一个环节。不过，严苛的FDA对某些药物则显得青睐有加。这不，羊年刚过，FDA就发给了罗氏和其合作者Exelixis公司一个"大红包"！FDA已经接受了两家公司提交的治疗黑色素瘤联合疗法上市申请，并表示将对这种疗法启动加速审批的待遇。此次罗氏公司和Exelixis公司开发的这种鸡尾酒疗法结合了Exelixis公司的新药cobimetinib和罗氏公司已上市的黑色素瘤药物Zelboraf，而后者此前已经被FDA批准用于治疗BRAF基因V600突变引起的黑色素瘤。罗氏旗下的Genentech公司在2006年就获得了cobimetinib的授权。作为回报，一旦这种联合疗法上市，Exelixis公司将获得美国市场50%的份额并分享全球市场版权。Cobimetinib是一种调节MEK激酶的药物，而MEK激酶的主要功能是调节生长因子受体相关通路，这一通路在肿瘤的发生发展中起着重要作用。
此次FDA同意对该疗法采用加速审批政策无疑大大缩短了这种药物上市所需要的时间。FDA预计将于今年的8月11日之前作出最终决定。与此同时，两家公司也并未闲着，而是双管齐下，同时进行欧洲市场的申请事宜。根据此次两家公司提供的临床数据显示，与单独使用Zelboraf相比，cobimetinib与Zelboraf联合治疗能够将患者的无进展生存期由单独使用的6.2个月延长至9.9个月。此次，FDA受理两家公司的药物申请无疑使这种药物疗法距离登陆市场更进一步。
详细英文报道：
Roche($RHHBY)andExelixis($EXEL)areonestepclosertoFDAapprovalfortheirskincancer-treatingcombinationtreatment,astheagencyhasacceptedtheirapplicationandpromisedaspeedyreview.
ThecompaniesareseekingapprovalforacombinationoftheExelixis-discoveredcobimetinibandRocheson-the-marketZelboraf,acocktailthattargetsmelanomapatientswiththeV600mutationintheirBRAFgenes.RochesGenentechunitlicensedcobimetinibbackin2006,and,ifthecombowinsapproval,Exelixisisentitledtoa50%shareofU.S.salesplusroyaltiesonglobalrevenue.
Theagencyhasgrantedthecombinationitspriorityreviewstatus,cuttingfourmonthsoffofitsstandardtimelineandpromisingtohandinafinaldecisionbyAug.11.RocheandExelixisarealsoawaitingEuropeanapprovalafterfilinganapplicationinSeptember.
EachfilingisbasedonPhaseIIIdatainwhichthecombinationhelpedsubjectslivesignificantlylongerwithouttumorgrowththanthosetreatedwithZelborafalone,hittingtheprimarygoalofprogression-freesurvival(PFS).PatientstreatedwiththecombinationchartedamedianPFSof9.9monthscomparedto6.2monthsonZelboraf,thecompaniessaid.
"TheFDAsacceptanceofthecobimetinibNDAbringsusonestepclosertoapotentialnewtreatmentoptionforpatientswithadvancedBRAFV600mutation-positivemelanoma,aformofthediseaseforwhichnewapproachesareneeded,"ExelixisCEOMichaelMorrisseysaidinastatement.
ThenewssentExelixissharesupnearly10%inpremarkettradingonThursday,butpervasivesetbackswiththebiotechswhollyownedpipelinehavemarredinvestorconfidence.Thecompanysleadasset,cabozantinib,failedtobeattheimmunosuppressantprednisoneinaPhaseIIItrialinprostatecancerlastyear,resultsthatsentthebiotechssharesplummeting.Exelixispromptlymovedtocutabout70%ofitsworkforce,paringdownitsoperationwhileholdingouthopefortwoongoingstudiestestingcabozantinibseffectonkidneyandlivercancers.
ExelixiscameupwithcobimetinibandadvancedittotheINDstagebeforesigningonwithGenentech,reaping$40millionupfront.ThedrugworksbyshuttingdownthekinaseMEK,apathwaythatregulatesgrowthfactorreceptorsandplaysahandinhelpingtumorsproliferate.

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