Tebchaws Asmeskas FDA pom zoo BeiGene Brukinsa (zanubrutinib) qhov qhia tshiab: kho Waldenstrom's macroglobulinemia!-2/2

Brukinsa (covzanubrutinib) yog tib chav kawm ntawm cov tshuaj raws li blockbuster anticancer tshuaj Imbruvica (ibrutinib) ntawm lub khw. Imbruvica (ibrutinib) yog lub ntiaj teb' thawj BTK inhibitor raug muag thiab tau pom zoo thawj zaug thaum Lub Kaum Ib Hlis 2013.

Imbruvica (ibrutinib) yog blockbuster BTK inhibitor muag los ntawm Johnson& Johnson thiab AbbVie. Nws ua rau tiv thaiv qog noj ntshav los ntawm kev thaiv BTK qhov xav tau rau kev loj hlob ntawm tes mob qog noj ntshav thiab mob qog noj ntshav. BTK yog lub cim tseem ceeb ntawm cov txheej txheem hauv B cell receptor signaling complex, uas ua lub luag haujlwm tseem ceeb hauv kev muaj sia nyob thiab nthuav dav ntawm cov hlwb B siab phem thiab ntau lwm yam kab mob tsis zoo. Imbruvica tuaj yeem thaiv txoj hauv kev taw qhia uas cuam tshuam txog kev tsis tuaj yeem loj hlob thiab kis ntawm B cells, pab tua thiab txo tus naj npawb ntawm cov qog nqaij hlav cancer, thiab ncua kev mob qog noj ntshav. Hauv kev sim tshuaj, tshuaj ib leeg thiab kev kho mob ua ke tau pom muaj txiaj ntsig zoo los tiv thaiv ntau yam ntawm hematological malignancies.

Txij li nws tau pib xyoo 2013, Imbruvica tau txais 11 Asmeskas FDA pom zoo hauv 6 kab mob suav nrog 5 B-cell qog ntshav qog ntshav thiab mob qog noj ntshav-tiv-tus kab mob (cGVHD): cov uas muaj lossis tsis muaj 17p tshem tawm kev hloov pauv (del17p). Cov qog ntshav lymphocytic mob ntev (CLL), lymphocytic lymphoma me (SLL) nrog lossis tsis muaj 17p tshem tawm kev hloov pauv (del17p), Waldenstrom' macroglobulinemia (WM), yav tas los kho mantle cell lymphoma (MCL), Marginal zone lymphoma (MZL) ) uas xav tau kev kho mob thiab tau txais tsawg kawg ib txoj kev kho los tiv thaiv CD20, thiab kev mob qog noj ntshav-tiv thaiv tus kab mob (cGVHD) uas ua tsis tiav ib lossis ntau qhov kev kho mob.

Hauv Suav teb, Imbruvica (ibrutinib) tau pom zoo thawj zaug thaum Lub Yim Hli 2017 thiab qhov kev qhia tshiab tau pom zoo thaum lub Kaum Ib Hlis 2018. Hauv 2018 kev sib tham txog kev pov hwm kho mob, Imbruvica (Yike ®, Ibruvica) tau ua tiav nkag mus rau hauv lub tebchaws cov ntawv pov hwm kev kho mob los ntawm kev txiav tus nqi ntau. Thaum Lub Kaum Ob Hlis 2020, National Medical Security Administration tau tshaj tawm xyoo 2020 tsab ntawm National Medical Insurance Catalog. Imbruvica (Yike®, Ibruvica) tau ua tiav txuas ntxiv thiab 2 qhov kev qhia tshiab tau ntxiv. Tag nrho ntawm 5 qhov kev qhia tseem ceeb tau suav nrog hauv daim ntawv tshiab ntawm kev pov hwm kev kho mob hauv tebchaws. txheem.

Tshwj xeeb, nws suav nrog: cov tshuaj ib leeg yog tsim rau kev kho mob mantle cell lymphoma (MCL) cov neeg mob uas tau txais tsawg kawg ib txoj kev kho mob yav dhau los; cov tshuaj ib leeg yog qhov tsim nyog rau kev kho mob qog noj ntshav lymphocytic leukemia (CLL)/cov neeg mob lymphocytic lymphoma me me (SLL); Ib tus neeg sawv cev tsim nyog rau kev kho mob ntawm cov neeg mob Waldenstrom' s macroglobulinemia (WM) uas tau txais tsawg kawg ib txoj kev kho mob yav dhau los, lossis kho kab mob thawj zaug ntawm cov neeg mob Waldenstrom' macroglobulinemia (WM) uas tsis haum rau kev siv tshuaj kho mob thiab tshuaj tiv thaiv kab mob; Tuximab tsim nyog rau kev kho mob ntawm cov neeg mob Waldenstrom' s macroglobulinemia (WM). Ntawm lawv, qhov taw qhia rau kev kho mob ntawm cov neeg mob nrog Waldenstrom' s macroglobulinemia (WM) yog cov lus qhia tshiab uas tau them nyiaj rov qab.

Tam sim no, AbbVie thiab Johnson& Johnson tab tom loj hlob Imbruvica loj heev (ibrutinib) txoj haujlwm txhim kho qog nqaij hlav. Raws li daim ntawv tshaj tawm txhua xyoo tshaj tawm los ntawm ob tog, kev muag khoom thoob ntiaj teb ntawm Imbruvica (ibrutinib) xyoo 2020 mus txog 9.442 billion daus las Asmeskas.