Astellas Xtandi (Enzalutamide) Qhov Kev Qhia Tawm Tshiab Txog Yuav Tsum Pom Zoo Los Ntawm EU

Lub tuam txhab lag luam tshuaj Astellas tshaj tawm tsis ntev los no tau tshaj tawm tias Pawg Neeg Saib Xyuas Kev Noj Tshuaj hauv Tebchaws Europe (EMA) rau Cov Khoom Siv Tshuaj rau Tib Neeg Siv (CHMP) tau tshaj tawm cov lus pom zoo hais tias Xtandi (enzalutamide) tau txais kev pom zoo rau cov cim tshiab: Kev kho mob ntawm cov neeg mob laus nrog metastatic hormone- rhiab mob prostate (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 tshiab.

Tam sim no, CHMP cov tswv yim yuav muab xa mus rau European Commission (EC) rau kev tshuaj xyuas, uas feem ntau ua qhov kev txiav txim siab zaum kawg li ntawm 2 hlis. Yog tias tau txais kev pom zoo, Xtandi tsuas yog kho qhov ncauj ntawm qhov ncauj tau pom zoo los ntawm EC rau kev kho ntawm 3 ntau hom kev mob qog nqaij hlav prostate: tsis-metastatic thiab metastatic castration resistant prostate cancer (CRPC), mHSPC.

Qhov tshuaj xyuas zoo ntawm CHMP yog saib raws cov ntaub ntawv los ntawm pivotal Phase 3 ARCHS mus sib hais (NCT02677896). Qhov kev sim siab sau npe rau 1150 cov neeg mob mHSPC thiab tshawb xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm Xtandi thiab cov placebo hauv kev sib xyaw nrog androgen kev tiv thaiv txoj kev kho (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 qhov kev phais mob thiab / lossis androgen deprivation Therapy (ADT) tau muaj.

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.

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) Inhibition of androgen losis tswvyim dabtsi-androgen los ua ke tsim kev hloov pauv kom ua rau txais cov kev ua haujlwm rov qab; (2) Tiv thaiv nuclear hloov chaw-AR hloov chaw rau nucleus yog kauj ruam tseem ceeb hauv AR-mediated noob kev tswj hwm; (3) Tsis muaj zog DNA khi-Kev sib txuas ntawm AR thiab DNA 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 txais kev pom zoo thaum lub Kaum Ib Hlis 2019 thiab Kaum Ib Hlis 2020 feem: (1) Rau kev kho mob asymptomatic lossis cov tsos mob me me thiab tsis tau txais tshuaj kho mob tom qab tsis ua tiav ntawm androgen deprivation therapy (ADT) Cov neeg mob loj uas muaj metastatic castration-resistant prostate mob qog noj ntshav (mCRPC); (2) Rau kev kho mob ntawm qhov tsis-metastatic castration-resistant prostate cancer (nmCRPC) cov neeg laus uas muaj kev pheej hmoo siab ntawm metastasis.