Johnson&Johnson Lub Hnyav Tshaj Hnyav CD 38 Lub Hom Phiaj Los tiv thaiv mob qog noj tshuaj Darzalex (Zhao Ke Sub) Subcutaneous Txhaj Tshuaj Siv Tau Siv Rau Kev Lag Luam Hauv Nyij Pooj!

Janssen Cov Chaw Ua Tshuaj, ib lub chaw tsim khoom ntawm Johnson& Johnson (JNJ), tsis ntev los no tau xa Daim Ntawv Thov Tshuaj Tshiab (NDA) rau Ministry of Health, Labour thiab Welfare (MHLW) nrhiav kev pom zoo rau kev txhaj tshuaj subbaraneous ntawm Darzalex (SC) kev npaj rau kev kho mob ntawm cov neeg mob uas muaj ntau yam mob myeloma (MM). Daim ntawv noj tshuaj yog tsim los siv Halozyme' s ENHANZE tshuaj xa tawm tshuab, thiab cov qauv tshuaj muaj cov tib neeg hyaluronidase PH 20 (rHuPH 20). Thaum Lub Xya Hli 20 19, Janssen Pharmaceuticals kuj tau xa daim ntawv thov ntxiv rau Darzalex SC mus rau Asmeskas FDA thiab EU EMA. Darzalex cov khoom lag luam tam sim no ntawm kev ua lag luam yog kev tso ntshav tshuaj (IV) npaj.

Daim ntawv noj tshuaj tshiab tshiab no yog ib qho piv txwv ntawm Johnson& Johnson' s tsis mob siab nrhiav kev kho dua tshiab los pab txhawb cov neeg mob uas muaj ntau hom mob myeloma. Qhov tseem ceeb, qhov ua tau zoo ntawm Darzalex SC formulation yog piv rau cov txheej txheem IV uas twb muaj lawm, thiab nws txo qhov tshwm sim ntawm qhov infusion cuam tshuam nrog, cuam tshuam txo lub sijhawm cov neeg mob tau txais kev kho mob, los ntawm ob peb teev mus txog kwv yees 5 feeb.

Daim ntawv thov no yog saib raws cov ntaub ntawv los ntawm Ntu II kev soj ntsuam kev kawm PLEIADES (MMY 2040) thiab Theem III soj ntsuam kev kuaj mob COLUMBA (MMY 3012). COLUMBA yog ib qho kev tshawb nrhiav txog-nyob rau hauv cov neeg mob uas muaj ntau yam mob myeloma uas yav dhau los tau txais tsawg kawg 3 kev kho mob (suav nrog proteasome inhibitor [PI], immunomodulator [IMiD]) lossis refractory rau ob qho tib si PI thiab IMiD nqa tawm thiab sib piv qhov ua tsis tau zoo ntawm Darzalex SC thiab Darzalex IV.

Cov txiaj ntsig tau pom tias Darzalex SC thiab Darzalex IV tau ua haujlwm zoo (tag nrho cov lus teb: 41% vs 37%, piv= 1. 11, 95% CI: 0.89-11. 90% CI: 90% -122%) tsis muaj qhov ua tsis tau zoo, thiab cov thawj coj siv sijhawm tsawg dua (5 feeb vs 3 teev lossis ntau dua), thiab qhov xwm txheej ntawm qhov kev txiav txim siab hais txog kev cuam tshuam yog qhov tsawg dua (13% vs 35%).

Darzalex (Zhao Ke®, Daretuzumab): Tuam Tshoj' s thawj CD 38 tsom monoclonal tshuaj, hloov kho kev kho mob myeloma

Hauv Suav teb, Darzalex (Zalco®, Daretuzumab) tau pom zoo rau kev lag luam thaum Lub Kaum Hlis 2019. Cov tshuaj no haum rau ib leeg-kev kho mob ntawm cov neeg laus cov neeg mob uas muaj mob rov huam dua thiab ntau yam mob myeloma, tshwj xeeb: yav tas los tau txais Cov neeg mob uas suav nrog kev kho mob nrog proteasome inhibitors thiab immunomodulators thiab muaj kev mob ntawm kev kho mob kawg. Raws li Tuam Tshoj' s thawj zaug pom zoo CD 38 monoclonal antibody tsom cov tshuaj, txoj hauv kev tshiab no cia siab txhais qhov kev kho mob ntawm ntau tus mob myeloma hauv Suav.

Darzalex yog lub ntiaj teb' s ua ntej pom zoo CD38-mediated, cytolytic tshuaj tiv thaiv nrog cov kev ua kom dav-tua neeg, uas tuaj yeem tsom thiab khi rau cov kev qhia tawm transmembrane tshaj tawm tsis pub dhau CD 38 molecule ntawm cov thaj chaw ntawm ntau lub myeloma thiab ntau cov qog nqaij hlav hlwb ， Induce tuag sai ntawm cov qog nqaij hlav los ntawm ntau cov txheej txheem tiv thaiv kab mob, nrog rau kev tiv thaiv cytotoxicity (CDC), tiv thaiv cov kab mob tiv thaiv kab mob cell-mediated cytotoxicity (ADCC) thiab cov kab mob tiv thaiv. phagocytosis (ADCP)) Thiab los ntawm apoptosis. Ntxiv rau, Darzalex kuj tseem tau pom tias yuav txhawb cov kabmob tiv thaiv kabmob hlwb hauv cov qog microenvironment los ua kom pom cov kabmob kev ua haujlwm.

Darzalex tau pom zoo rau kev tso npe thawj zaug thaum lub Kaum Ib Hlis 2015, nrog muag $ {{1}. {{2}} billion nyob rau hauv {{1 }} 0 1 9. Tam sim no, cov tshuaj tau raug pom zoo los ntawm ntau lub teb chaws nyob hauv lub ntiaj teb rau thawj-kab, kab thib ob, thiab ntau kab kev kho mob ntawm ntau yam mob myeloma. Cov lus taw qhia kev pom zoo muaj nyob hauv ntau lub teb chaws, suav nrog: (1) Lub Kaum Ib Hlis 2015, raws li Kev Kho Mob Monotherapy, siv rau MM cov neeg laus cov neeg mob uas yav tas los tau txais tsawg kawg yog 3 tshuaj (nrog rau proteasome inhibitor [PI] thiab ib qho tshuaj tiv thaiv immunomodulator [IMiD]) lossis muaj dual refractory rau PI thiab immunomodulator; (2) Kaum Ib Hlis {{1}} 0 1 6, sib xyaw nrog lenalidomide thiab dexamethasone, lossis sib xyaw bortezomib thiab dexamethasone, rau MM cov neeg laus uas tau txais yav tas los tsawg kawg ib txoj kev kho mob; (3) Lub Rau Hli {{1}} 0 1 7, Ua ke nrog pomalidomide thiab dexamethasone, rau MM cov neeg laus cov neeg mob uas tau txais tsawg kawg {{{1}} kev kho mob (suav nrog lenalidomide thiab PI); ({{1 5}}) Lub Tsib Hlis {{1}} 0 1 8, sib xyaw nrog bortezomib thiab melphalan) Thiab prednisone rau cov neeg laus laus uas tau nrhiav tus kabmob MM uas tsis haum rau autologous qia cell hloov chaw (ASCT). Qhov kev pom zoo no ua rau Darzalex thawj cov tshuaj monoclonal antibody tau pom zoo rau kev kho tus mob MM tshiab. (5) Lub Rau Hli {{1}} 0 1 9, lenalidomide thiab dexamethasone tau siv rau cov neeg laus MM tau kuaj mob uas tsis haum rau ASCT. (6) Lub Cuaj Hli {{1}} 0 1 9, ua ke nrog bortezomib, thalidomide thiab dexamethasone rau cov neeg nyuam qhuav raug mob tshiab MM cov neeg mob uas tsim nyog rau ASCT, qhov kev pom zoo ua Darzalex thawj qhov tshiab pom zoo kom tsim nyog rau ASCT Kev kuaj mob txheeb raws roj ntsha hauv cov neeg mob nrog MM.

Thaum Lub Ob Hlis 2019, Darzalex' s kev sib cais noj tshuaj kuj tau pom zoo los ntawm Asmeskas FDA. Qhov kev pabcuam no yuav ua rau kev xaiv rau cov kws paub txog kev noj qab haus huv hauv kev kho mob ntawm MM cov neeg mob raws li lawv cov kev xav tau. Thawj txoj kev tso ntshav ntawm Darzalex yuav muab faib los ntawm ib zaug-ib zaug ntxiv rau hauv 2 sib luag nrog txoj kev mob hla dej.

Thaum Lub Ob Hlis Ntuj xyoo no, Johnson& Johnson Pharmaceuticals tau tsim daim ntawv thov cov khoom siv roj ntsha ntxiv (sBLA) rau Asmeskas FDA kom tau txais kev pom zoo rau Darzalex thiab Kyprolis (carfilzomib, carfilzomib) thiab dexamethasone cov tshuaj sib xyaw (DKd) rau Kev Kho Mob ntawm cov neeg mob uas rov mob lossis rov qab tso ntau yam mob myeloma (R / R MM) )). SBLA yog raws kev soj ntsuam Phase III kawm txog CANDOR (NCT 03158688). Nws tsim nyog teev tias qhov no yog thawj theem III kawm ua ke los ua ke ob yam tshuaj nrog cov txheej txheem tseem ceeb ntawm kev nqis tes ua, Darzalex (anti-CD 38 monoclonal antibody) thiab Kyprolis (proteasome inhibitor), hauv kev kho mob ntawm ntau yam mob myeloma (MM )). Cov ntaub ntawv tau qhia tias tom qab kev soj ntsuam nruab nrab ntawm 17 lub hlis, txoj kev tshawb no tau mus txog qhov kawg ntawm kev vam meej tsis muaj txoj sia (PFS): piv nrog Kd kho pab pawg, muaj kev pheej hmoo ntawm tus kab mob lossis tuag hauv KdD kev kho mob pab pawg tau raug txo los ntawm 37% (HR=0. 630; 95% CI: 0. 464, 0. {{1 3} }; p=0. {{1 5}}). Qhov nruab nrab PFS ntawm KdD kho mob pawg yog 15. {{1 7}} hlis, thiab PFS nruab nrab ntawm KdD kho mob pawg tseem tsis tau mus txog. Ntxiv nrog rau qhov mus txog qhov kawg qhov kawg, KdD kuj tseem pom qhov tseem ceeb ntawm cov ntsiab lus tseem ceeb kawg piv rau Kd, suav nrog: ORR (84. 3% vs 74. {{21} }%, p=0. {{2 3})), MRD tsis zoo ntawm 12 lub hlis ntawm kev kho mob-ua tiav Tus nqi kho dua tshiab (12. 5% vs { {28}}. 3%, ze li ntawm 1 0-nce nce, p< 0.="" 0001),="" os="" (nruab="" nrab="" ntawm="" ob="" pawg="" tsis="" tau="" mus="" txog,="" hr="0" .="" 7="" 5;="" 95%="" ci:="" 0.="" 49,="" 1,="" 1="" 3;="" p="0." 08="" )).="" hauv="" kev="" tshawb="" nrhiav,="" kev="" nyab="" xeeb="" ntawm="" kdd="" raws="" tu="" qauv="" tau="" xwm="" yeem="" nrog="" kev="" paub="" txog="" kev="" nyab="" xeeb="" ntawm="" txhua="" cov="" tshuaj="" hauv="" cov="" txheej="">

Tam sim no, Darzalex thiab Kyprolis tau dhau los ua cov qauv tseem ceeb rau kev kho mob ntawm ntau yam mob myeloma (MM). Cov txiaj ntsig tau los ntawm CANDOR txoj kev tshawb fawb muab pov thawj muaj zog hais tias KdD cov tshuaj muaj lub zog txaus thiab ntev kawg rau kev kho mob rau cov neeg mob uas muaj tus mob rov huam tuaj. Kev sib xyaw ntawm Kypropris (tiv thaiv proteasome inhibitor) thiab Darzalex (anti-CD 38 monoclonal antibody), ob lub tshuaj uas muaj zog, sawv cev rau txoj kev cog lus tshiab rau kev kho cov neeg mob uas rov mob lossis rov huam tuaj ua ntau yam mob myeloma. (Bioon.com)