FDA的相关官员对辉瑞公司此次提交的临床二期数据表示满意

2015年2月4日讯/生物谷BIOON/--辉瑞公司最近宣布，公司开发的palbociclib最近获得了FDA相关部门的肯定，这也为palbociclib的最终上市扫清了障碍（相关阅读：CDK4/6市场开启在望——FDA优先审查辉瑞乳腺癌明星药palbociclib）。Palbociclib是通过阻断CDK4和CDK6两种酶来治疗患有转移性乳腺癌的绝经期妇女患者。FDA的相关官员对辉瑞公司此次提交的临床二期数据表示满意。而FDA作出这一决定的时间比其最终期限提前了两个月之多，这也为辉瑞公司在竞争激烈的CDK抑制剂药物开发市场中取得领先位置提供了便利。目前辉瑞公司在这一领域中的主要对手包括了礼来和诺华等制药巨头。
分析人士预计，一旦palbociclib获得FDA的最终批准上市，其年销售额峰值将达到30亿-50亿美元之多。通常，许多抗癌药物都是通过作用于表皮生长因子受体来达到抗肿瘤效果，而目前发现很多乳腺癌患者并不表达这种受体。Palbociclib的创新之处就在于这种药物的靶向目标变为了雌激素受体。从而为这类乳腺癌患者提供了新的选择。同时，FDA还表示palbociclib还有望与另一种抗癌药物letrozole联合治疗专一性乳腺癌。这也是辉瑞公司在开辟自己的肿瘤疗法研发部门后取得的首个胜利。
新年伊始，辉瑞公司正在大刀阔斧地开辟自己的肿瘤药物部门。去年，辉瑞公司曾经尝试以1180亿美元的的价格收购阿斯利康，以获得其继续的肿瘤免疫疗法研发部门，然而由于各方面的原因，这一收购案最终胎死腹中。不过，辉瑞公司并未就此偃旗息鼓。不久，辉瑞公司就和德国默克公司签订了价值数亿美元的肿瘤免疫疗法研发协议（相关阅读：土豪中的战斗机！辉瑞与默克签订28亿美元合作协议开拓公司肿瘤免疫疗法）。或许2015年将成为辉瑞公司研发部门重组后的一个丰收年。
详细英文报道：
Pfizer($PFE)pickedupaspeedyFDAnodforpalbociclib,abreastcancertreatmentwithblockbusterpotential,barrelingtowardthemarketasitworkstocarveoutabiggershareoftheoncologyspace.
Thedrug,whichworksbyinhibitingtheenzymesCDK4andCDK6,isnowclearedforuseinpostmenopausalwomenwithmetastaticbreastcancer.TheapprovalisbasedonPhaseIIdataandcomesmorethantwomonthsaheadoftheagencysdecisiondeadline,completingwhathasbeenacharmedtripthroughtheregulatoryprocessforPfizer.Theoraltreatment,whichwillsellasIbrance,isexpectedtobringinsalesbetween$3billionand$5billionayearatitspeak,accordingtoLeerinkanalystSeamusFernandez.
TheapprovalputsPfizeraheadofacomingcrowdofCDKinhibitors,includingpromisingcontendersfromEliLilly($LLY)andNovartis($NVS),andgivesthecompanyafirstmajorsuccessasitbeginsaneweraincancertreatments.Palbociclibslightning-fastapprovalalsoaffirmsFDAoncologychiefRichardPazdurswillingnesstohurryalongso-calledbreakthroughtreatmentsthatcouldchangethestandardofcare,acauseforoptimismamongdevelopersofsimilardrugs.
Pfizersdrugisspecificallyindicatedforwomenwhosecancersrespondtoestrogenreceptorbutdontexpresshumanepidermalgrowthfactorreceptor2(HER2),anditstobeusedincombinationwiththeoncologydrugFemara(letrozole),theFDAsaid.
"Theadditionofpalbociclibtoletrozoleprovidesanoveltreatmentoptiontowomendiagnosedwithmetastaticbreastcancer,"Pazdursaidinastatement."TheFDAiscommittedtoexpeditingmarketingapprovalofcancerdrugsthroughouracceleratedapprovalregulations."
PfizerismovingonfromlastyearspursuitofAstraZeneca($AZN),a$118billiongambitdrivenlargelybytheallureofthatcompanysimmuno-oncologypipeline.Intheensuingmonths,Pfizerstruckaslewofdealstocobbletogethersomepromisingnewassetsthatcouldhelpitcatchupwiththetitansofthefield,payingMerckKGaA$850millionupfrontforthePD-L1inhibitorMSB0010718Candpromisingasmuchas$2billionmoretocollaborateonupto20newcancerimmunotherapies.
ThedealtookthepressurethepressureoffofPfizeranditsbusinessdevelopmentsquadintheaftermathoftheAstraZenecadebacle,CEOIanReadsaidlastmonth,addingthat"ourresearchpipeline,middlestagetolatestage,isstrong,andIwouldrathertakeourcapitalrightnowanddirectittoopportunitiestoaccelerateEPSgrowth."
AndpalbociclibssuccessisanaffirmationofPfizersabilitytocompetewiththeleadersinoncology,ReadsaidinastatementTuesday.
"IamproudoftheclinicalprogramforIbrance,whichwasdiscoveredinPfizerlaboratories,andtheinnovationweareabletobringforwardtothebreastcancercommunitytoday,"Readsaid."...TodaysFDAapprovalofIbrancemarksapivotalmilestonethatdemonstratesthestrengthofourscience,providesanimportantmedicinetopatientsinneedandunderscoresthecontributionsourcompanycanmaketosociety."
Pfizerslate-stagepipelineincludesbococizumab,amemberofanewfangledclassofcardiotherapieswithblockbusterexpectations,andertugliflozin,aMerck($MRK)-partnereddiabetestreatment.
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