Qhov Qhia Tawm Tshiab Ntawm Astellas Xtandi (enzalutamide) Tau Pom Zoo los ntawm European Union Thiab Tau Raug Sau Npe Hauv Suav Teb!

Lub tuam txhab lag luam tshuaj Astellas tau tshaj tawm tsis ntev los no hais tias European Commission (EC) tau pom zoo tshiab rau Xtandi (enzalutamide): rau kev kho mob rau cov neeg mob laus uas muaj metastatic hormone-mob prostate cancer (mHSPC). mHSPC tseem tseem hu ua metastatic castration-sensitive prostate cancer (mCSPC). Tus txiv neej kuaj pom tias muaj mHSPC feem ntau muaj qhov tsis pom muaj txiaj ntsig zoo, nrog kev muaj sia nyob ntev li ntawm 3-4 xyoos, uas qhia txog qhov yuav tsum tau kho sai ntawm cov kev xaiv kho tshiab.

Nrog rau cov kev pom zoo kawg no, Xtandi tau dhau los ua cov tshuaj qhov ncauj tam sim no tau pom zoo los ntawm European Union rau kev kho mob ntawm 3 ntau hom kev kho mob prostate: tsis-metastatic thiab metastatic castration resistant prostate cancer (CRPC), mHSPC.

Qhov kev pom zoo no yog raws cov ntaub ntawv los ntawm piv rau Kev Kawm Phaub 3 ARCHS txoj kev tshawb (NCT02677896). Txoj kev tshawb no tau sau npe rau 1150 mHSPC cov neeg mob thiab tshawb xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm Xtandi thiab cov placebo ua ke nrog androgen deprivation therapy (ADT).

Cov txiaj ntsig tau pom tias txoj kev tshawb no tau mus txog qhov kawg ntawm kev ntsuas kev vam meej-tsis muaj sia nyob (rPFS): Piv nrog cov placebo + ADT cov pawg, pawg Xtandi + ADT pawg tau txo qhov kev pheej hmoo ntawm radiological zuj zus lossis kev tuag los ntawm 61% (HR=0.39 [95% CI: 0.30-0.50]; p< 0.0001).="" hauv="" qhov="" kev="" sim="" no,="" kev="" nyab="" xeeb="" ntawm="" xtandi="" zoo="" ib="" yam="" nrog="" kev="" nyab="" xeeb="" ntawm="" crpc="" cov="" chaw="" sim="" ua="" ntej.="" cov="" xwm="" txheej="" tsis="" zoo="" (ae)="" ntawm="" qib="" 3="" lossis="" siab="" dua="" (txhais="" tau="" tias="" mob="" hnyav="" xiam="" oob="" khab="" lossis="" lub="" neej="" muaj="" kev="" kub="" ntxhov)="" yog="" nyob="" ntawm="" kev="" kho="" mob="" xtandi="" +="" adt="" regimen.="" cov="" neeg="" mob="" tau="" zoo="" sib="" xws="" rau="" cov="" neeg="" uas="" tau="" txais="" cov="" placebo="" +="" adt="" regimen="" (24.3%="" vs="">

Ntiaj teb, prostate cancer yog qhov thib ob ua rau ploj tuag hauv tus txiv neej tom qab mob ntsws. Prostate cancer feem ntau tshwm sim rau cov neeg laus thiab feem ntau tshwm sim los ntawm kev noj tshuaj ntau dhau ntawm txiv neej cov txiv neej (nrog rau testosterone, uas yog androgen). Cov kev siv tshuaj rau kev kho mob kom txo tau cov qib androgens hauv lub cev, uas tuaj yeem ua kom zoo nkauj los ntawm kev phais thiab / lossis androgen deprivation Therapy (ADT) tau tiav.

Metastatic prostate cancer yog hais txog cov qog nqaij hlav cancer uas tau kis mus rau lwm qhov ntawm lub cev (xws li cov pob txha, cov qog ntshav, zais zis, thiab lub qhov quav) dua li cov qog. Yog tias tus neeg mob tseem tau teb rau cov txheej txheem phais mob lossis tshuaj noj kom txo qis testosterone tsawg thaum lub sijhawm no, nws raug suav tias yog Hormone (lossis castration) rhiab. Rau cov txiv neej muaj mob mHSPC uas pib ADT, lub sij hawm nruab nrab muaj txoj sia nyob ntev li 3-4 xyoos.

Professor Andrew Armstrong, tus kws tshuaj ntsuam xyuas ntawm ARCHS txoj kev tshawb nrhiav thiab tus thawj coj ntawm Duke Cancer Institute Center ntawm Prostate Cancer thiab Mob Lub Hlwb Mob Qog Hais Txog Tus kabmob, tau hais tias:" Cov kev xaiv rau cov neeg mob uas muaj metastatic hormone-prostate cancer (mHSPC) muaj tsawg. Hmoov tsis zoo, ntau tus neeg mob muaj qhov ntsuas tsis zoo. Txoj kev tshawb nrhiav ARCHS muab cov ntaub ntawv pov thawj tshawb nrhiav pom tias Xtandi tuaj yeem txhim kho qhov kev mob ntawm mHSPC cov neeg mob, uas yog cov kws kho mob nyob sab Europe nrog txoj kev daws teeb meem uas tuaj yeem kho thoob plaws ntu txuas ntxiv ntawm kev mob qog nqaij hlav prostate."

Andrew Krivoshik, Tus Lwm Thawj Coj ntawm Oncology Kev Loj Hlob thiab Taub Hau Ntiaj Teb Kev Kho Mob ntawm Astellas tau hais tias: "Xtandi tau dhau los ua tus qauv paub tab rau cov neeg mob uas muaj mob qog nqaij hlav cancer. Txij li thaum nws pom zoo thawj zaug hauv xyoo 2012, muaj ntau dua 610,000 tus neeg mob thoob ntiaj teb. Siv. Kev pom zoo cov pov thawj tshiab rau Xtandi muab ntau qhov xav tau thiab ntxiv cov kev kho mob ntxiv rau cov neeg mob mHSPC thaum lub sijhawm txheej txheem kho. Peb cia siab tias yuav koom tes nrog cov neeg saib xyuas kev noj qab haus huv thoob plaws teb chaws Europe kom ntseeg tau tias cov neeg mob mHSPC tuaj yeem tau txais kev kho mob Xtandi sai li sai tau."

Xtandi (enzalutamide) yog ib qho androgen receptor signaling inhibitor. Nws yog noj ntawm qhov ncauj ib zaug ib hnub. Cov tshuaj ncaj qha rau lub hom phiaj androgen receptor (AR) thiab ua lub luag haujlwm hauv peb qib ntawm AR taw qhia txoj hauv kev: (1) Kev txwv ntawm androgen kev khi - androgen kev khi tsim kev hloov pauv kom ua rau muaj kev cuam tshuam receptor; (2) Tiv thaiv kev hloov chaw nuclear-AR hloov chaw mus rau lub nucleus yog ib kauj ruam tseem ceeb hauv AR-mediated gene kev tswj hwm; (3) Tsis muaj zog DNA khi-AR thiab DNA khi yog qhov tseem ceeb rau kev tswj hwm kev qhia tawm cov noob.

Xtandi tau tsim nyob rau xyoo 2012 thiab yog cov khoom lag luam loj hauv kev kho mob prostate. Cov tshuaj tau txais kev pom zoo rau ntau txoj kev kho mob, uas txawv ntawm lub teb chaws mus rau lub teb chaws, suav nrog: metastatic castration-resistant prostate cancer (mCRPC), tsis-Metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration-sensitive prostate cancer (mCSPC) Cov. Nws yog tshwj xeeb muaj nuj nqi tias Xtandi yog thawj cov khoom tau pom zoo rau kev kho mob ntawm peb qhov tshwj xeeb ntawm kev mob qog nqaij hlav prostate (nmCRPC, mCRPC, mCSPC).

Hauv Suav Teb, Xtandi (enzalutamide) tau pom zoo thaum lub Kaum Ib Hlis 2019 thiab Kaum Ib Hlis 2020 feem: (1) Rau kev kho mob ntawm asymptomatic lossis mob me me ntawm cov neeg mob uas tsis tau txais kev kho mob tom qab tsis ua haujlwm ntawm androgen deprivation kho (ADT) (2) Rau kev kho mob ntawm qhov tsis-metastatic castration-tiv thaiv prostate cancer (nmCRPC) cov neeg mob laus uas muaj kev pheej hmoo siab txog metastasis.