AbbVie's BTK Tus Kws Kho Mob Imbruvica US Cov Lus Qhia Yuav Ntxiv: Xam nrog 5-xyoo Cov Ntaub Ntawv Ntev

Tsis ntev los no AbbVie tshaj tawm tias Tsoomfwv Meskas Cov Khoom Noj thiab Tshuaj (FDA) tau lees txais cov tshuaj tiv thaiv kabmob kheesxaws Imbruvica (ibrutinib) ua ke nrog rituximab (rituximab) los kho Waldenström' s macroglobulinemia, WM) Tshuaj Ntxiv Tshuaj Tshiab (sNDA) Cov. WM yog ib qho mob tsis tshua muaj thiab tsis pom qhov tsis yog Hodgkin' s lymphoma (NHL). Lub sNDA hom phiaj txhawm rau hloov kho cov ntaub ntawv tshiab ntawm Asmeskas ntawm Imbruvica los ntawm cov ntaub ntawv tshawb xyuas ntawm theem III iNNOVATE cov chaw kuaj mob rau ntau tshaj 5 xyoos. Qhov no tseem yog cov ntaub ntawv taug qab ntev tshaj plaws tam sim no muaj rau BTK kev kho mob ntawm WM.

Imbruvica yog qhov ncauj Bruton tyrosine kinase (BTK) inhibitor, sib koom tsim thiab ua lag luam los ntawm AbbVie' s Pharmacyclics thiab Johnson& Johnson' s Janssen Biotechnology. Imbruvica tau pom zoo thawj zaug ua kev kho mob rau WM hauv 2015, ua thawj zaug thiab tsuas yog FDA pom zoo tshuaj kho WM. Xyoo 2018, Imbruvica kuj tau pom zoo ua ke nrog rituximab los kho WM, los ua thawj cov tshuaj tsis muaj tshuaj lom neeg kho mob sib xyaw rau WM. Raws li tam sim no, Imbruvica tsuas yog BTK inhibitor pom zoo rau kho WM.

Txoj kev tshawb nrhiav iNNOVATE (PCYC-1127) tau ua hauv kev tsis muaj kev kho mob yav dhau los WM cov neeg mob thiab cov neeg mob uas tau rov ua dua tshiab / rov ua dua tshiab WM, thiab tau tshuaj xyuas qhov ua tau zoo thiab qhov tseem ceeb ntawm Imbruvica + rituximab regimen piv rau rituximab + placebo regimen Cov. kev nyab xeeb. Cov kev tshaj tawm yav dhau los pom tau hais tias tom qab kev soj ntsuam nruab nrab 30 lub hlis, Imbruvica + rituximab-kho cov neeg mob tau txhim kho cov kab mob tsis muaj mob ntau dua piv rau rituximab + cov placebo pawg (qhov tsis muaj mob-ciaj sia: 82% vs 28%, HR=0.20, p< 0.001).="" cov="" txiaj="" ntsig="" ntawm="" kev="" tshawb="" xyuas="" mus="" sij="" hawm="" ntev="" los="" ntawm="" txoj="" kev="" tshawb="" no="" yuav="" tshaj="" tawm="" ntawm="" kev="" sib="" tham="" txog="" kev="" kho="" mob="" yav="" tom="">

Danelle James, tus thawj coj ntawm kev txhim kho thoob ntiaj teb rau Imbruvica, uas yog cov neeg muag khoom ntawm AbbVie lub khw muag tshuaj tau hais tias:" Txij li Imbruvica ua thawj FDA pom zoo tshuaj rau WM ntau dua tsib xyoos dhau los, nws tau hloov qhov tsis tshua muaj peev xwm, tsis kho tsis-Ho Chikin' s lymphoma kho cov qauv. Cov ntawv thov tshiab no yuav ntxiv dag zog rau li cas Imbruvica muab cov kev xaiv kho mob tshiab rau cov neeg mob WM thiab peb txoj kev mob siab txhawb nqa cov zej zog neeg mob 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 cov neeg mob nrog WM, suav nrog Chav Kawm Ib Pawg muaj feem rau kev kho mob WM thawj zaug.

Dr. Meletios a. Dimopoulos, tus kws tshuaj ntsuam ntawm iNNOVATE kev tshawb fawb, tus xibfwb thiab tus thawjcoj ntawm Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv ntawm National Medical College ntawm Athens thiab Capodister University Lub Tsev Kawm Ntawv ntawm Tshuaj, hais tias:" Peb tau ua qhov kev txhim kho tseem ceeb hauv kev kho WM. Mus txog li ob peb xyoos dhau los, Cov Kev Kho Mob rau hom mob no tseem muaj tsawg heev, suav nrog kev siv tshuaj kho. Txoj kev tshawb nrhiav iNNOVATE tseem muab cov pov thawj muaj zog ua pov thawj los txhawb kev siv ntev ntawm Imbruvica ua ke nrog rituximab hauv kev kho mob thawj zaug thiab thib ob ntawm WM cov neeg mob."

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

Imbruvica yog thawj tus Bruton tyrosine kinase (BTK) inhibitor yuav tau noj qhov ncauj ib hnub ib zaug. Nws tso tawm cov nyhuv anticancer los ntawm thaiv BTK uas yuav tsum muaj mob qog nqaij hlav loj hlob thiab metastasis. BTK yog qhov tseem ceeb tshaj tawm cov khoom lag luam nyob hauv B-cell receptor signaling complex, thiab ua lub luag haujlwm tseem ceeb hauv kev muaj sia nyob thiab metastasis ntawm malignant B hlwb thiab ntau lwm yam kab mob hnyav. Imbruvica tuaj yeem thaiv cov kev taw qhia uas daws cov kev tswj tsis tau thiab nthuav tawm ntawm cov hlwb B, pab tua thiab txo qis cov qog nqaij hlav cancer, thiab ncua kev mob tshwm sim ntawm qog nqaij hlav cancer. Hauv kev sim tshuaj, kev siv yeeb tshuaj ib leeg thiab kev kho mob sib xyaw ua ke tau pom tias muaj txiaj ntsig zoo tiv thaiv ntau yam kev mob hematological.

Txij li thaum nws pib xyoo 2013, Imbruvica tau txais 11 FDA pom zoo nyob rau hauv tag nrho ntawm 6 tus kab mob thaj chaw nrog rau 5 B-cell ntshav qog nqaij hlav thiab mob leeg-mob tiv thaiv kab mob (cGVHD): mob mus ntev los yog tsis muaj 17p tshem tawm kab mob sib cais (del17p) Lymphocytic leukemia (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 xav tau kev kho mob zoo thiab tau txais tsawg kawg ib qho los tiv thaiv CD20 kho mob, kev mob caj dab-tiv thaiv tus kab mob-tiv thaiv kab mob (cGVHD) uas tsis ua tiav nrog kev kho mob nrog ib lossis ntau hom kev kho mob.

Txog rau tam sim no, Imbruvica tau siv rau hauv cov cim kev pom zoo los kho ntau dua 200,000 tus neeg mob thoob ntiaj teb, suav nrog 5,300 tus neeg mob WM hauv Tebchaws Meskas.

Ntawm nimno, AbbVie thiab Johnson& Johnson tau nce qib rau Imbruvica ua cov kabmob loj hlob rau kev kho mob hauv phiaj xwm. Kev lag luam muaj kev cia siab zoo txog Imbruvica' Lub Ib Hlis xyoo no, ib tsab xov xwm luam tawm nyob rau sab saum toj thoob ntiaj teb phau ntawv xov xwm" Natural-Tshuaj Tshawb Pom Tshawb Pom" (Cov khoom lag luam zoo tshaj plaws kev kwv yees rau 2020) kwv yees tias Imbruvica' s thoob ntiaj teb kev muag khoom hauv 2020 yuav nce mus txog $ 6.818 billion. EvaluatePharma, lub koom haum tshawb fawb kev lag luam tshuaj, kuj kwv yees tias Imbruvica yuav ntxiv $ 1 nphom hauv kev muag khoom hauv 2020. Nrog txuas ntxiv kev lag luam thiab nce ntxiv, qhov muag thoob ntiaj teb yuav nce mus txog $ 9,5 nphom hauv 2024.