Erleada Tau Pom Zoo Hauv Suav Tebchaws Rau Qhov Kev Qhia Tawm Tshiab Rau Kev Kho Mob ntawm Metastatic Endocrine Kev Kho Mob-rhiab Prostate Cancer

Lub Yim Hli 14, 2020, Xi'an Janssen Pharmaceutical Co., Ltd., lub chaw tsim khoom ntawm Johnson& Johnson hauv Suav teb, tshaj tawm hnub no hais tias nws lub cim tshiab-androgen receptor inhibitor Erleada® (apalutamide) rau cov cim tshiab tau pom zoo los ntawm National Medical Products Administration tau pom zoo rau kev kho mob rau cov neeg laus nrog metastatic endocrine therapy-rwj prostate cancer (mHSPC). Thaum lub Cuaj Hlis xyoo tas los, Erleada ® tau pom zoo rau kev kho mob ntawm qhov tsis-metastatic castration-resistant prostate cancer (NM-CRPC) cov neeg laus cov neeg mob uas muaj kev pheej hmoo ntawm metastasis. Thaum Lub Ob Hlis Ntuj xyoo no, Erleada®' s mHSPC hais qhia tau pom dua" Kev Ntsuas Ua Ntej Rov Ntsuas" cov xwm txheej los ntawm National Medical Products Administration. Kev pom zoo ntawm cov ntawv pov thawj no tau cia siab tias yuav tsum tau ua tiav kev kho mob sai sai ntawm cov neeg mob uas muaj mob qog nqaij hlav qog nqaij hlav hauv Suav teb.

Kaum xyoo dhau los, kev muaj mob qog ua rau mob qog nqaij hlav hauv Suav tau nce zuj zus tuaj, thiab nws tau dhau los ua cov kab mob hauv cov txiv neej feem ntau hauv cov txiv neej Suav, nyob qib plaub ntawm cov hlav. Nws kwv yees tias muaj 56,600 tus neeg mob qog nqaij hlav cancer hauv kuv lub teb chaws txhua xyoo tshaj 60 xyoo. Nrog rau kev laus ntawm peb lub teb chaws cov pej xeem, qhov tshwm sim ntawm kev mob qog nqaij hlav prostate yuav tsum txuas ntxiv.

Prostate cancer kuj tau raug piav raws li" tus neeg tua ntsiag to" ;. Nws tsis yooj yim rau pom nyob rau hauv nws thaum ntxov. Feem ntau cov neeg mob nyob hauv Suav teb twb dhau ntawm theem siab thaum lawv kuaj pom, thiab 54% ntawm cov neeg mob twb tau tsim cov pob txha metastases thaum lawv mus ntsib kws kho mob. Feem ntau ntawm cov neeg nyuam qhuav mob raws kab mob qog nqaij hlav hauv lub teb chaws Suav nyob hauv mHSPC theem. mHSPC hais txog kev mob qog nqaij hlav prostate uas tau kis mus rau lwm qhov ntawm lub cev thiab teb rau kev kho mob castration (suav nrog kev phais mob thiab kev kho mob castration kho mob). Cov neeg mob nyob rau theem ntawm tus kab mob no ntsib kev phom sij ntau dua, thiab qhov kwv yees hais txog kev kho thiab lub neej zoo tsis yog qhov zoo.

Xib fwb Ye Dingwei los ntawm Tsev Kho Mob Cancer ntawm Fudan University qhia hais tias, "Thaum mob qog nqaij hlav prostate muaj metastasized, qhov nyuaj ntawm kev kho mob yuav nce siab. Lub tsoos endocrine kev kho tam sim no nyob rau hauv kev siv xav tau kev pom zoo ntxiv. Raws li kev kawm TITAN, rau cov neeg mob mHSPC, Erleada® ua ke nrog androgen deprivation txoj kev kho (ADT txoj kev kho) Nws tuaj yeem nqa cov kev pab cuam muaj sia nyob rau cov neeg mob uas muaj metastatic prostate cancer. Txawm hais tias tau kuaj mob metastasis pom, cov neeg mob yuav tsum tsis poob kev ntseeg siab. Ntxov kho thaum ntxov thiab txiaj ntsig thaum ntxov. Cov kev kho mob nquag yuav pab txo kev mob tus kab mob, ncua ntev lub neej, thiab txhim kho lub neej kom zoo."

Lub TITAN txoj kev tshawb no yog muaj kev pheej hmoo, ob qhov muag tsis pom kev, tshuaj placebo, tshuaj thoob ntiaj teb multicenter Theem 3 soj ntsuam sim. Cov txiaj ntsig ntawm txoj kev tshawb nrhiav pom tias piv nrog cov placebo ua ke nrog ADT, Erleada® ua ke nrog ADT tuaj yeem ua kom ntev tag nrho kev muaj sia nyob ntawm cov neeg mob nrog metastatic endocrine kho-rwj prostate cancer (mHSPC) thiab txo kev pheej hmoo tuag los ntawm 33% (HR=0.67; 95)% CI, 0.51-0.89; P=0.0053), qhov phom sij ntawm kev txhim kho lossis tuag tau txo los ntawm 52% (HR=0.48; 95 feem pua ​​CI, 0.39-0.60; P<>

Raws li qhov ua tau zoo thiab kev nyab xeeb qhia los ntawm TITAN txoj kev tshawb fawb, European Association of Urology (EAU) cov lus qhia thiab National Comprehensive Cancer Network (NCCN) cov lus qhia sau cov tshuaj tshiab antiandrogenic apatamide ua ke nrog ADT ua ib qho ntawm cov kev kho mob tau pom zoo rau mHSPC Cov. Nrog kev hloov kho ntawm cov txheej txheem thoob ntiaj teb no, mHSPC tau nkag mus rau hauv lub sijhawm ntawm kev kho cov tshuaj endocrine tshiab.

Dr. Peter Lebowitz, Lub taub hau ntawm Global Oncology Kev Kho Mob ntawm Janssen Kev Tshawb Fawb thiab Kev Loj Hlob, taw qhia:" Tsis hais tus neeg mob' s degree ntawm tus kab mob lossis kev kho mob docetaxel yav dhau los, Erleada® muaj lub peev xwm los hloov kev kho mob ntawm cov neeg mob qog mob cancer, pab lawv ncua tus mob thiab ncua ntev. Cov keeb kwm no qhia tau hais tias Janssen tau mob siab rau cov neeg mob Suav. Peb tau cog lus los txuas ntxiv txhim kho cov xwm txheej ntawm kev kuaj mob qog ntshav qab zib thiab kev kho mob, thiab txuas ntxiv txhim kho cov kev daws teeb meem rau cov neeg mob ntawm txhua theem ntawm tus kab mob."

Dr. Li Zili, tus thawj coj ntawm Yangsen Asia-Pacific R& D Center, tau hais tias: “Peb paub tias tsis yog txhua txhua tus kab mob qog prostate zoo ib yam. Yuav kom ua tau raws li kev kho mob nyuaj rau tus mob qog nqaij hlav prostate ntawm ntau cov kab mob sib txawv, peb txuas ntxiv mus tshawb hauv chaw kuaj mob ntawm cov kev daws teeb meem tshiab. Cov neeg mob qog ntshav hauv Suav coj lwm txoj kev kho mob tshiab tseem ceeb los ua kom tau raws li lawv qhov kev xav tau kho ntxiv."

Asgar Rangoonwala, Thawj Tswj Hwm ntawm Xi'an Janssen Pharmaceutical Co., Ltd. tau hais tias: "Muaj kev cog qoob loo ntau nyob rau hauv Suav teb tau 35 xyoo, Xi'an Janssen tau mob siab rau cov kev xav tau kev kho mob ntawm cov neeg mob ntawm txhua theem ntawm kev mob qog nqaij hlav prostate. Erleada® thiab Zeke® (cov ntsiav tshuaj abiraterone acetate) tau pab hloov kho kev kho tus mob prostate. Txhawm rau txhim kho lub neej zoo ntawm cov neeg mob. Lub neej yav tom ntej, peb tseem yuav koom tes nrog tsoomfwv cov tuam tsev thiab txhua tus neeg hauv kev lag luam los txhim kho kev nkag tau rau txoj kev siv tshuaj tshiab, ua tiav peb txoj kev mob siab rau cov neeg mob Suav, thiab ua txhua yam kev ua tiav rau kev tshawb nrhiav tshuaj tshiab thiab kev tsim kho sai sai Cov av tau txais txiaj ntsig rau txhua tus neeg mob."

Erleada® yog Xi'an Janssen qhov kev hloov kho thib ob rau kev kho mob qog nqaij hlav cancer. Yav dhau los, Zeke® tau txais kev pom zoo hauv 2015 thiab 2018, ntsig txog, rau kev kho mob ntawm metastatic castration-resistant prostate cancer (mCRPC) hauv kev sib xyaw nrog prednisone, thiab kev sib xyaw nrog prednisone los yog prednisolone rau kev kho mob ntawm Diagnosed high-metastatic endocrine therapy rhiab mob prostate (mHSPC).