Johnson&Johnson / Imbruvica (Ibrutini) Tau Pom Zoo Los Ntawm Asmeskas FDA rau 11 Qhov Kev Qhia Tawm Thiab 6 Rau Kev Kho Kab Mob Ntshav!

Johnson& Johnson (JNJ) thiab AbbVie (AbbVie) tsis ntev los no tau tshaj tawm tias Tsoom Fwv Meskas Khoom Noj thiab Tshuaj (FDA) tau pom zoo thawj kab kev kho mob rau cov tshuaj tiv thaiv kab mob tshuaj Imbruvica (ibrutinib, ibrutinib) nrog rituximab Cov neeg mob uas muaj mob lymphocytic leukemia (CLL) lossis cov lymphocytic lymphoma me me (SLL). Lub cim tseem ceeb no tau pom zoo 11 lub FDA pom zoo los ntawm Imbruvica nyob rau thaj chaw muaj kabmob sib txawv thiab 6 qhov kev pom zoo ntawm kev kho mob CLL txij li kev pom zoo thawj zaug xyoo 2013. CLL yog hom kev mob qog ntshav ntau tshaj plaws rau cov neeg laus.

Kev pom zoo raug pom zoo los ntawm FDA' s ntawm lub sij hawm sim kho oncology (RTOR) cov phiaj xwm kev sim, Orbis qhov project, thiab cov txheej txheem tshuaj xyuas kev ua ntej. Imbruvica yog thawj tus Bruton tyrosine kinase (BTK) inhibitor yuav tau noj qhov ncauj ib hnub ib zaug. Nws yog ob leeg tsim thiab ua lag luam los ntawm AbbVie' s Tsev muag tshuaj thiab Johnson& Johnson' s Janssen Biotechnology. Raws li tam sim no, Imbruvica tau siv los kho ntau dua 195,000 cov neeg mob thoob ntiaj teb hauv cov cim tau pom zoo.

Qhov kev pom zoo kawg no tau ua raws li kev soj ntsuam Phase III E1912 kev kawm (NCT02048813). Txoj kev tshawb no tau soj ntsuam tag nrho ntawm 529 tus neeg mob CLL ≤70 xyoo uas tsis tau txais kev kho mob yav tas los. Hauv kev tshawb nrhiav, cov neeg mob no tau raug xaiv los txais Imbruvica + rituximab (n=354) lossis chemoimmunotherapy FCR (fludarabine + cyclophosphamide + rituximab, n=175). Thawj qhov kawg yog kev vam meej-tsis muaj sia nyob (PFS), thiab theem ob kawg yog qhov kev ciaj sia tag nrho (OS).

Cov txiaj ntsig tau pom tias piv nrog FCR kev kho mob pab pawg, PFS thiab OS hauv Imbruvica + rituximab kev kho mob pab pawg tau zoo dua. Cov ntaub ntawv kev nyab xeeb hauv txoj kev tshawb no yog sib luag nrog cov yam ntxwv paub txog kev nyab xeeb ntawm Imbruvica.

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 cov tshuaj uas muaj tshuaj me me uas yuav noj ntawm ncauj ib hnub ib zaug. Nws mas exerts anticancer nyhuv los thaiv Bruton' s tyrosine kinase (BTK), uas yuav tsum muaj mob qog nqaij hlav cancer 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 cell thiab ntau lwm yam kab mob hnyav.

Imbruvica tuaj yeem thaiv cov kev taw qhia uas daws cov kev tsis sib kis thiab kev sib kis ntawm B hlwb, 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 tshuaj ib leeg thiab kev kho mob sib xyaw ua ke tau pom muaj kev ua tau zoo tiv thaiv ntau yam ntawm hematological malignancies.

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 xws li 5 kab mob ntshav B-mob ntshav thiab mob leeg ntshav-tiv tiag-tiv thaiv tus kab mob (cGVHD): mob mus ntev los yog tsis muaj 17p kev tshem tawm kab mob (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 yuav tsum muaj kev kho mob zoo thiab tau txais tsawg kawg ib qho los tiv thaiv CD20 kho mob, mob leeg-mob tiv thaiv kab mob-tiv thaiv kab mob (cGVHD) uas tsis ua tiav nrog kev kho mob nrog ib lossis ntau hom kev kho mob.

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 hauv phau ntawv xov xwm thoob ntiaj teb sab saum toj" Natural-Tshuaj Tshawb Pom Kev Pom Zoo" (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 hais tias Imbruvica yuav ntxiv $ 1 nphom hauv kev muag khoom hauv 2020. Nrog txuas ntxiv kev ua lag luam thiab qhia tau ntau ntxiv, cov khoom muag thoob ntiaj teb yuav nce mus txog $ 9,5 nphom hauv 2024. (Bioon.com)