AbbVie BTK Tus Txhim Kho Imbruvica (ibrutinib) Asmeskas Kev Tshawb Xyuas Cov Ntaub Ntawv Hloov Kho: 5 Xyoo Ntawm Cov Ntaub Ntawv Ntev

Tsis ntev los no AbbVie tshaj tawm tias Tsoomfwv Meskas Khoom Noj thiab Tshuaj (FDA) tau pom zoo hloov kho cov ntaub ntawv tshuaj rau lub hom phiaj tshuaj anticancer Imbruvicaibrutinib), suav nrog: Imbruvica ua ke nrog rituximab rau kev kho mob ntawm Fahrenheit macroglobulinemia Kev ua tau zoo thiab cov ntaub ntawv kev nyab xeeb ntawm Waldenström' s macroglobulinemia (WM). WM yog ib qho mob tsis tshua muaj thiab tshwm sim tsis-Hodgkin's lymphoma (NHL). Qhov kev pom zoo no yog suav raws li kev ntsuam xyuas cov ntaub ntawv kawg ntawm Ntu 3 iNNOVATE cov chaw kuaj mob ntev dua 5 xyoos, uas tseem yog BTK kev kho mob ntev tshaj plaws rau WM. Cov ntaub ntawv rov qab txhawb nqa kev siv mus sij hawm ntev ntawm Imbruvica ua ke nrog rituximab hauv thawj-kab thiab thib ob-kab kev kho mob ntawm WM cov neeg mob.

Imbruvica yog qhov ncauj Bruton' s tyrosine kinase (BTK) inhibitor, ua ke tsim thiab ua lag luam los ntawm AbbVie' s Pharmacyclics thiab Johnson& Johnson' s Janssen Biotechnology. Imbruvica tau pom zoo thawj zaug xyoo 2013 thiab tam sim no raug siv los kho ntau yam mob qog nqaij hlav ntshav thiab mob leeg ntshav-mob nrog ua rau cov neeg muaj mob. Raws li cov ntaub ntawv tshawb xyuas tseem ceeb hauv iNNOVATE txoj kev tshawb nrhiav, Imbruvica tau pom zoo rau xyoo 2015 yog kev kho mob rau tshuaj rau WM, los ua thawj zaug thiab tsuas yog cov tshuaj pom zoo los ntawm Asmeskas FDA rau kev kho mob ntawm WM. Xyoo 2018, Imbruvica kuj tau pom zoo kom sib xyaw nrog rituximab los kho WM, dhau los ua thawj cov tshuaj tua kab mob tsis sib haum rau WM. Txog tam sim no, Imbruvica tsuas yog BTK inhibitor pom zoo kom kho WM.

Txoj kev tshawb nrhiav iNNOVATE (PCYC-1127) tau ua hauv WM cov neeg mob uas tsis tau txais kev kho mob dua thiab cov neeg mob uas rov huam dua / tso tawm kom rov ua haujlwm. Nws ntsuas qhov ua tau zoo thiab qhov ua tau zoo ntawm Imbruvica + rituximab regimen piv rau rituximab + placebo regimen. kev nyab xeeb. Cov ntaub ntawv tshawb xyuas kawg muaj nyob rau hauv Imbruvica cov ntaub ntawv tshuaj qhia tau hais tias kev soj qab taug qab tag nrho rau 63 lub hlis, piv nrog rituximab + cov placebo pawg, qhov kev pheej hmoo ntawm tus kab mob kev loj hlob lossis kev tuag hauv Imbruvica + rituximab kho pab pawg tau raug txo qis npaum li 75% (HR=0.25; 95% CI: 0.15-0.42; p< 0.0001).="" hauv="" kev="" tshawb="" nrhiav,="" cov="" kev="" mob="" tshwm="" sim="" feem="" ntau="" (≥20%)="" ntawm="" cov="" neeg="" mob="" kho="" nrog="" imbruvica="" +="" rituximab="" yog="" nqaij="" doog,="" mob="" nqaij,="" mob="" ntshav="" tawm,="" teeb="" meem="" ntshav,="" raws="" plab,="" pob="" tawv="" nqaij,="" mob="" pob="" qij,="" xeev="" siab="" thiab="" ntshav="">

Danelle James, tus thawj coj ntawm kev txhim kho thoob ntiaj teb rau Imbruvica, Pharmacyclics, uas yog lub khw muag khoom ntawm AbbVie, tau hais tias: "Peb tau txais kev txhawb siab los ntawm FDA qhov kev lees paub tam sim no vim tias nws qhia peb cov kev mob siab rau pab txhawb cov neeg mob cuam tshuam los ntawm WM. Imbruvica tsuas yog FDA pom zoo. Ib hom tshuaj rau kev kho mob ntawm WM, tam sim no nws cov ntaub ntawv tshuaj tau hloov kho, suav nrog ntau tshaj 5 xyoos ntawm kev nyab xeeb thiab cov ntaub ntawv siv tau, uas yuav pab nkag siab zoo dua los kho tus mob ntshav tsawg no."

WM feem ntau cuam tshuam rau cov neeg laus, feem ntau hauv cov leeg pob txha, txawm hais tias cov qog ntshav thiab hnoos qeev kuj tseem cuam tshuam. Hauv Tebchaws Meskas, muaj kwv yees li 2,800 tus neeg mob tus mob WM tshiab txhua xyoo. Thaum lub Tsib Hlis 2020, National Comprehensive Cancer Network (NCCN) tau pom zoo Imbruvica nrog lossis tsis muaj rituximab yog thawj qhov kev xaiv rau WM cov neeg mob, suav nrog kev qhia ua ntej I kev pabcuam rau WM kev kho mob thawj.

11 qhov qhia rau 6 kab mob: kev muag khoom yuav nce mus txog US $ 6.8 nphom hauv 2020 thiab US $ 9,5 nphom hauv 2024

Imbruvica yog tus tho kev Bruton' s tyrosine kinase (BTK) inhibitor uas tau noj ntawm qhov ncauj ib zaug ib hnub, thiab tawm qhov cuam tshuam los tiv thaiv tus mob qog nqaij hlav los ntawm thaiv BTK, uas yog xav tau rau kev mob kheesxaws ntawm tes nthuav dav thiab metastasis. BTK yog lub teeb meem tseem ceeb tshaj tawm hauv B cell receptor signaling complex, thiab nws ua lub luag haujlwm tseem ceeb hauv kev muaj sia nyob thiab metastasis ntawm malignant B cell thiab lwm yam kab mob hnyav. Imbruvica tuaj yeem thaiv cov kev teeb liab uas sib cais ntawm qhov tsis muaj kev txwv thiab kis ntawm B hlwb, pab tua thiab txo qis cov qog nqaij hlav cancer, thiab ncua kev mob tshwm sim ntawm qog nqaij hlav. Hauv kev sim tshuaj, kev siv tshuaj ib leeg thiab kev sib txuas ua ke tau pom muaj kev ua tau zoo los tiv thaiv ntau yam ntawm hematological malignancies.

Txij li thaum nws pib xyoo 2013, Imbruvica tau txais 11 FDA pom zoo rau tag nrho ntawm 6 tus kab mob xws li 5 kab mob ntshav B-cell thiab mob qog ntshav-mob tiv thaiv kab mob (cGVHD): cov kab mob mus ntev los yog tsis muaj 17p ua kom muaj kab mob sib kis (del17p) (CLL), lymphocytic lymphoma me me (SLL) nrog lossis tsis muaj 17p ntawm kev hloov pauv (del17p), Waldenstrom macroglobulinemia (WM), yav tas los kho mantle cell lymphoma (MCL), Marginal tsam lymphoma (MZL) uas yuav tsum muaj kev kho mob thiab tau txais yam tsawg kawg ib qho tshuaj tiv thaiv CD20, kev kho mob nyuaj rau mob tiv thaiv tus kab mob (cGVHD) uas tau ua tsis tiav ib lossis ntau txoj kev kho mob.

Txog rau hnub tim, Imbruvica tau siv los kho ntau dua 200,000 tus neeg mob thoob ntiaj teb hauv cov cim pom zoo. Tam sim no, AbbVie thiab Johnson& Johnson tau nce qib rau Imbruvica ua cov kabmob loj hlob rau kev kho mob. Kev lag luam muaj kev cia siab zoo txog Imbruvica' Lub Ib Hlis xyoo no, ib tsab xov xwm (Cov kwv yees hais txog cov khoom lag luam rau xyoo 2020) luam tawm nyob rau hauv phau ntawv xov xwm thoob ntiaj teb sab saum toj" kwv yees hais tias Imbruvica' s thoob ntiaj teb kev muag khoom nyob rau hauv 2020 yuav mus txog 6.818 billion US dollars. EvaluatePharma, lub koom haum tshawb fawb txog kev lag luam tshuaj, kuj tau kwv yees tias Imbruvica yuav ntxiv 1 nphom nyiaj daus las hauv kev muag khoom hauv 2020. Raws li kev ua lag luam txuas ntxiv mus thiab kev ntsuas tseem pheej nce ntxiv, kev muag khoom thoob ntiaj teb yuav nce mus txog 9,5 billion Asmeskas las nyob rau xyoo 2024.