GlaxoSmithKline Zejula (niraparib) Pom Zoo Los Ntawm EU: Thawj Kab-Tib tus neeg saib xyuas Kev Kho Mob Platinum-sensitive Ovarian Cancer!

GlaxoSmithKline (GSK) tsis ntev los no tshaj tawm tias European Commission (EC) tau pom zoo lub hom phiaj tshuaj tua kab mob Zejula (hom npe: niraparib) raws li thawj-kab ib leeg-tus neeg saib xyuas kev kho mob kom ua tiav kev kho mob tom qab tau txais platinum-muaj tshuaj kho lossis ib feem ntawm kev zes qe menyuam. mob kheesxaws (nrog rau kev mob qog rau qe menyuam, mob qog ua rau lub raum. Hais txog kev cai Asmeskas, thaum kawg lub Plaub Hlis xyoo no, Zejula' s ntxiv cov ntawv thov tshuaj tshiab (sNDA) rau tib qho kev ntsuas pom zoo tau pom zoo los ntawm FDA.

Nws tsim nyog teev tias qhov kev pom zoo no ua rau Zejula yog thawj tus neeg sawv cev PARP inhibitor rau cov neeg mob qog nqaij hlav zes qe menyuam qib siab uas teb rau platinum-muaj tshuaj kho rau thawj cov kab kho kev kho nyob hauv European Union, khij qhov kev nce qib loj hauv kev kho mob ntawm zes qe menyuam. Cov. Vim tias ua ntej ntawd, tsuas yog 20% ​​ntawm cov neeg mob qog nqaij hlav zes qe menyuam, uas yog, cov neeg mob BRCA hloov pauv (BRCAm), tau tsim nyog siv cov tshuaj PARP inhibitors li monotherapy hauv kev kho thawj zaug kev kho mob.

Kev pom zoo no tau txais txiaj ntsig los ntawm cov txiaj ntsig ntawm Kev Tshawb Fawb III PRIMA (ENGOT-OV26 / GOG-3012). Hauv txoj kev tshawb fawb no, cov neeg mob uas muaj tus kab mob qib siab (theem III lossis IV) uas tau txais kev zam txim tom qab tau txais thawj kab-muaj cov tshuaj tua kab mob plasma raug cia li raug xaiv kom tau txais Zejula lossis placebo kev kho mob ntawm 2: 1 piv. Thawj qhov kawg yog qhov kev vam meej-tsis muaj sia nyob (PFS). Cov Tib Neeg Zejula kho thaum xub thawj tau suav nrog kev tshawb fawb: cov neeg mob lub cev qhov hnyav< 77="" kg="" thiab="" lossis="" platelet="">< 150k="" μl,="" cov="" koob="" tshuaj="" thawj="" zaug="" yog="" 200="" mg="" ib="" hnub="" ib="" zaug;="" qhov="" pib="" siv="" rau="" lwm="" tus="" neeg="" mob="" yog="" 300="" mg="" ib="" hnub="" ib="">

Cov ntaub ntawv qhia tau hais tias nyob rau hauv homologous recombination defect (HRd) cov pejxeem, tag nrho cov neeg kawm (tsis hais txog lub sijhawm biomarker), thiab BRCA kev hloov pauv ntawm cov pejxeem, Zejula thawj-kab kev saib xyuas kev kho txo ​​qhov kev pheej hmoo ntawm tus kab mob kev loj hlob lossis tuag piv nrog placebo 57% (HR=0.43; 95% CI: 0.31-0.59; p< 0.0001),="" 38%="" (hr="0.62;" 95%="" ci:="" 0.50-0.76;="">< 0.001),="" 60%="" (hr="0.40" ;="" 95%="" ci:="" 0.27-0.62;=""><>

Daim ntawv qhia txog kab mob kev nyab xeeb muaj nyob hauv qhov kev tshawb fawb no yog xwm yeem nrog cov ntawv soj ntsuam kev nyab xeeb uas yav dhau los tau pom los ntawm Zejula. Piv nrog rau cov pej xeem sawv daws, qhov tshwm sim ntawm cov kev tsis zoo (TEAE) hauv qib 3/4 kev kho mob ntshav nrog kev noj tshuaj rau tus kheej raws li qhov hnyav ntawm lub cev thiab / lossis platelet suav tau qis dua, suav nrog thrombocytopenia (21% vs 39%)), ntshav tsis txaus ( 23% vs 31%), thiab neutropenia (15% vs 21%). Cov txiaj ntsig ntawm kev ua tiav tus neeg mob qhia tau hais tias lub neej zoo ntawm Zejula kho pab pawg thiab cov placebo pab pawg zoo sib xws.

Ntiaj teb, mob kheesxaws ntawm zes qe menyuam yog qhov yim neeg mob ua rau neeg mob cancer tuag taus rau tus pojniam. Hauv Tebchaws Meskas thiab Tebchaws Europe, kwv yees li 22,000 thiab 65,000 tus pojniam tau kuaj pom tias muaj kabmob kheesxaws ntawm zes qe menyuam txhua xyoo. Txawm hais tias thawj-platinum-muaj cov tshuaj tua kab mob muaj cov lus teb tau zoo, kwv yees li ntawm 85% ntawm cov neeg mob yuav ntsib mob rov qab los. Thaum rov muaj mob, nws nyuaj kho, thiab lub sijhawm nyob nruab nrab ntawm txhua qhov kev rov tshwm sim yog luv.

Lub PRIMA txoj kev kawm sau npe cov neeg mob uas pom kev kho cov lus teb rau thawj kab-muaj cov tshuaj tua kab mob, nrog rau cov uas muaj kev pheej hmoo siab ntawm kev mob tshwm sim. Qhov no yog cov pejxeem uas muaj kev xav tau kev pab kho mob siab thiab tsis muaj feem cuam hauv kev tshawb nrhiav kab mob cancer ntawm zes qe menyuam ua ntej lawm. Txoj kev tshawb no yog qhov kev kawm txog av. Cov ntaub ntawv ua pov thawj qhov tseem ceeb ntawm Zejula' s thawj kab kev kho kev kho mob thiab nws cov txiaj ntsig kho mob rau cov poj niam uas muaj mob qog mis. Zejula ib leeg-tus neeg saib xyuas thawj kho kab mob kev kho mob tom qab kev phais mob thiab thawj-platinum-muaj tshuaj kho yuav muab cov neeg mob nrog txoj kev kho mob tseem ceeb tshiab, uas tej zaum yuav kho tus kab mob ntawm zes qe menyuam.

Cov tshuaj kws tshaj tawm ntawm Zejula yog niraparib, uas yog lub qhov ncauj me me molecule poly ADP ribose polymerase (PARP) inhibitor uas tuaj yeem coj kom zoo dua ntawm cov tsis xws luag hauv DNA kho txoj hauv kev kom xav tau tua cov qog hlwb. Hom kev txiav txim siab no muab tshuaj kho mob Cov peev xwm rau ntau hom qog noj ntshav nrog DNA kho tsis xws luag. PARP muaj feem xyuam nrog ntau ntawm cov qog ntshav, tshwj xeeb yog mob cancer ntawm lub mis thiab zes qe menyuam. Zejula tau tsim los ntawm Tesaro, uas tau los ntawm GlaxoSmithKline thaum Lub Kaum Ob Hlis 2018 rau US $ 5.1 nphom (kwv yees li billion 4 billion). Thaum lub Cuaj Hlis 2016, Zai Lab tau pom zoo daim ntawv tso cai pom zoo nrog Tesaro, tso cai ntawm Zejula ntawm Tuam Tshoj Mainland, Hong Kong, thiab Macau.

Zejula tau txais kev pom zoo rau kev lag luam thaum lub Peb Hlis 2017. Cov cim tau pom zoo tam sim no muaj xws li: (1) Rau kev saib xyuas cov neeg mob uas muaj mob qog nqaij hlav hlav, mob qog hlav qog ntshav, lossis mob qog nqaij hlav peritoneal uas tag nrho lossis ib nrab ntawm kev kho mob platinum-muaj tshuaj kho. (2) Siv rau kev mob kheesxaws zes qe menyuam ntau heev, mob qog qe ntshav los yog kabmob peritoneum uas tau txais 3 lossis ntau dua kev siv tshuaj kho mob yav dhau los thiab nws cov kabmob muaj feem cuam tshuam nrog kev mob zoo ntawm homologous recombination defect (HRD) tau hais tseg hauv ib qho ntawm 2 yam hauv qab no Kev kho mob rau cov neeg mob qog noj ntshav: (a) mob los yog xav tias tsam BRCA kev sib pauv; (b) genome instability (GIS) thiab tus kab mob tau nce ntau dua 6 lub hlis tom qab teb rau platinum kawg muaj cov kws kho mob.

Hauv Hong Kong thiab Macau, Tuam Tshoj, Zejula tau pom zoo rau cov npe thaum Lub Kaum Hli 2018 thiab Lub Rau Hli 2019. Hauv Suav teb av loj, National Medical Products Administration (NMPA) tau pom zoo Zejula thaum Lub Kaum Ob Hlis 27, 2019. Qhov ntsuas pom tshuaj yog: rau kev mob tshwm sim rau lub cev ntawm zes qe menyuam. mob qog noj ntshav, qog qe ntshav qog, lossis mob qog nqaij hlav cancer uas ua kiag lossis ib feem kho los ntawm plasma muaj cov tshuaj kho mob. Kev kho tus kws kho mob rau cov neeg laus uas muaj mob khees xaws peritoneal.