AstraZeneca's BTK Tus Kws Lij Choj Tsis Txaus (acalabrutinib) Tau Txais Kev Pom Zoo Los Ntawm EU

AstraZeneca tau tshaj tawm tsis ntev los no hais tias European Commission (EC) tau pom zoo Calquence (acalabrutinib) rau kev kho mob ntawm cov neeg mob laus uas mob lymphocytic mob hlwb (CLL), tshwj xeeb: (1) raws li kev kho mob monotherapy lossis hauv kev sib xyaw nrog obinutuzumab, Kho tus neeg mob laus nrog CLL uas yav dhau los tsis tau txais kev kho mob; (2) Raws li kev saib xyuas mob hlwb, kho tus neeg mob laus nrog CLL uas yav tas los tau txais tsawg kawg ib txoj kev kho.

CLL yog hom leukemia uas tseem pom muaj tshaj rau ntawm cov laus. Hauv Tebchaws Meskas, Calquence tau pom zoo los ntawm FDA rau lub Kaum Ib Hlis 2019 rau kev kho mob ntawm cov neeg mob laus uas muaj CLL lossis cov nqaij hlav ntshav me me (SLL).

Kev pom zoo los ntawm EU yog saib raws li kev soj ntsuam 2 ntu III kev kawm (ELEVATE-TN, ASCEND). Ob qhov kev tshawb fawb no tau lees paub tias hauv thawj-kab kev kho mob ntawm CLL thiab kev kho mob los ntawm rov qab lossis rov ua haujlwm ntawm CLL, Calquence ua ke nrog obinutuzumab thiab raws li kev kho mob monotherapy qhia tau zoo dua hauv kev muaj kev vam meej tsis muaj sia nyob (PFS) piv nrog cov qauv kev saib xyuas tseem ceeb txo cov kev pheej hmoo ntawm mob zuj zus lossis tuag. Hauv 2 txoj kev tshawb nrhiav, Calquence tau zam zoo.

—— TSWV YIM-TN txoj kev tshawb nrhiav: ua rau cov neeg mob uas tsis tau txais kev kho yav tas los (naïve) CLL, kev soj ntsuam cov txiaj ntsig thiab kev ua haujlwm ntawm Calquence monotherapy, Calquence + obinutuzumab ua ke txoj kev kho, kev siv tshuaj kho mob-chovramotherapy chlorambucil + obinutuzumab ua ke kev nyab xeeb. Cov txiaj ntsig tau qhia tias, piv nrog kev siv tshuaj kho cov tshuaj chlorambucil + obinutuzumab ua ke kev kho, Calquence + obinutuzumab ua ke txoj kev kho thiab Calquence monotherapy ua rau txo qis kev pheej hmoo ntawm tus kab mob kev loj hlob lossis tuag los ntawm 90% thiab 80%, feem.

——ASCEND kev kawm: ua rau cov neeg mob uas rov huam dua lossis rov ua dua tshiab CLL, sib piv Calquence nrog kev kho mob xaiv los ntawm tus kws kho mob IdR (rituximab + idelalisib) lossis BR (rituximab + bendamustine)) Qhov ua tau zoo thiab kev nyab xeeb. Cov txiaj ntsig tau pom tias Calquence txo qis kev pheej hmoo ntawm kev mob lossis tuag taus los ntawm 69% piv nrog IdR lossis BR. Lub sijhawm 12 hli, 88% ntawm cov neeg mob hauv Calquence kho pawg tsis muaj kev vam meej, piv nrog 68% hauv pawg tswj hwm.

Paolo Ghia, MD, tus kws tshawb nrhiav txog ASCEND Theem III mus sim thiab tus thawj coj ntawm CLL Lub Tswvyim Tshawb Nrhiav Kev Kawm ntawm San Rafael University hauv Milan, hais tias: "Ib qho ntawm peb qhov teebmeem loj tshaj plaws rau kev kho mob ntawm CLL yog nrhiav kev kho mob ntev ntev, uas yog feem ntau cuam tshuam rau cov laus cov neeg mob uas mob comorbidities. Kev pom zoo niaj hnub no pom tau tias muaj kev txhim kho zoo heev rau cov neeg mob CLL hauv Tebchaws Europe, raws li Theem III kev sim tshuaj pom tau hais tias Calquence yog qhov kev txhim kho tseem ceeb piv rau kev kho mob tam sim no."

Dave Fredrickson, Tus Lwm Thawj Coj Thawj Coj ntawm AstraZeneca's Oncology Division, tau hais tias: "Qhov kev pom zoo no yog qhov kev hloov kho tseem ceeb rau cov neeg mob CLL nyob sab Europe, uas tam sim no tsuas xaiv cov kev kho mob uas tsis muaj kev xaiv-tshuaj dawb. Raws li peb thawj zaug mob cancer ntshav Nrog rau kev pom zoo nyob sab Europe, Calquence yuav muab ntau txhiab tus neeg mob CLL nrog cov phiaj xwm kho mob tshiab uas muaj txiaj ntsig zoo thiab tsis muaj peev xwm ua rau muaj kev cuam tshuam zoo rau lub neej zoo."

Calquence tau pom zoo los ntawm Asmeskas FDA rau kev ua lag luam nrawm nrawm rau Lub Kaum Hlis 2017. Qhov ntsuas muaj xws li: (1) Rau cov neeg laus cov neeg mob uas rov mob lossis tso ntshav rov qab mob hlwb (MCL) uas yav tas los tau txais tsawg kawg ib txoj kev kho; (2) Siv Rau Kev kho mob ntawm cov neeg mob laus nrog CLL lossis SLL.

Calquence' s lub tshuaj ua haujlwm sib xyaw yog acalabrutinib, uas yog cov khoom muaj txiaj ntsig zoo, muaj zog thiab covalent Bruton tyrosine kinase (BTK) inhibitor uas tiv thaiv BTK los ntawm kev khi ruaj khov. BTK yog kev tswj hwm qhov tseem ceeb ntawm B cell receptor (BCR) cov paib piav qhia. Nws tau dav dav hauv ntau hom kev hematological malignancies thiab koom nrog txoj kev loj hlob, thauj, chemotaxis thiab kev nplaum ntawm B hlwb. Yog li, nws yog ib qho tseem ceeb rau kev kho mob hematological malignancies. Phiajzeb. Hauv qhov kev tshawb fawb preclinical, acalabrutinib qhia tau tias muaj qhov cuam tshuam tsawg kawg-phiaj yam.

Tam sim no, Calquence raug tsim rau ntau hom B-cell ntshav qog nqaij hlav, nrog rau CLL, MCL, diffuse loj B-cell lymphoma (DLBCL), Waldenstrom macroglobulinemia (WM), follicular lymphoma (FL), Ntau yam myeloma thiab lwm yam mob ntshav txha caj qaum.

Calquence' s mechanism ntawm kev ua yog tib yam li AbbVie / J& J' s blockbuster ntshav mob qog ntshav Imbruvica (ibrutinib), uas yog thawj BTK inhibitor pom zoo thoob ntiaj teb. Txij li thaum nws pom zoo thawj zaug thaum Lub Kaum Ib Hlis 2013, Imbruvica tau pom zoo rau ntau npaum li ntawm 11 kev kho mob hauv 6 thaj chaw muaj kabmob, thiab kev muag khoom thoob ntiaj teb tau nce siab zuj zus. Thaum xaus lub Rau Hli xyoo no, lub koom haum kws tshawb fawb txog kev lag luam kev lag luam EvaluatePharma tso tawm cov lus kwv yees hais tias nrog cov kev lag luam txuas ntxiv mus thiab qhov taw qhia nce ntxiv, Imbruvica' s muag hauv 2026 yuav txog 10.722 billion US dollars, dhau los ua lub ntiaj teb' s thib tsib zoo tshaj plaws muag tshuaj.