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Johnson&Johnson FGFR kinase inhibitor Balversa ua ke nrog PD-1 inhibitor cetrelimab--2/2

[Oct 16, 2021]

Craig Tendler, MD, Tus Lwm Thawj Coj ntawm Post-Oncology Development thiab Kev Kho Mob Ntiaj Teb, Janssen Kev Tshawb Fawb thiab Kev Txhim Kho, tau hais tias: "Raws li thawj zaug pom zoo rau cov neeg mob uas muaj mob qog noj ntshav hauv zos lossis mob qog noj ntshav uas tau txais platinum-based chemotherapy thiab nqa FGFR3 lossis FGFR2 noob hloov. Kev kho mob, peb tau txais kev txhawb nqa los ntawm cov ntaub ntawv txuas ntxiv txhawb kev nyab xeeb thiab kev ua tau zoo ntawm Balversa, thiab cov txiaj ntsig ntawm Balversa hauv cov neeg mob uas tsis muaj kev kho mob siab. Peb lub hom phiaj yog ua ke ob hom tshuaj nquag (Balversa thiab cetrelimab), kom ua kom muaj txiaj ntsig zoo tshaj plaws ntawm kev sib xyaw ua ke rau cov neeg mob no."

erdafitinib

erdafitinib molecular qauv


Fibroblast growth factor receptors (FGFR) yog ib tsev neeg ntawm receptor tyrosine kinases uas tuaj yeem ua haujlwm los ntawm kev hloov pauv caj ces hauv ntau hom qog, uas tuaj yeem ua rau cov qog cell loj hlob thiab muaj sia nyob. Urothelial carcinoma (UC) yog hom mob qog noj ntshav ntau tshaj plaws, suav txog ntau dua 90% ntawm tag nrho cov mob qog nqaij hlav zais zis. Kwv yees li 20% ntawm cov neeg mob mUC muaj FGFR noob hloov. Tam sim no, kev kho tus qauv ntawm mUC yog cisplatin-based chemotherapy. Txawm li cas los xij, ntau dua 50% ntawm cov neeg mob mUC yuav tsis tsim nyog rau kev kho mob cisplatin, hais txog qhov xav tau kev kho tshiab. Lwm txoj hauv kev rau cov neeg mob mUC tau kuaj pom tshiab suav nrog cov tshuaj khomob sib txawv lossis PD-1 inhibitors, uas tuaj yeem txhim kho lub cev tiv thaiv kab mob ntawm T hlwb rau cov qog hlwb.


Balversa yog ib qho FGFR kinase inhibitor ib hnub ib zaug, tau pom zoo rau lub Plaub Hlis 2019: nws yog siv rau cov neeg laus uas muaj mob qog noj ntshav hauv zos lossis mob qog noj ntshav (mUC) nrog rau FGFR noob hloov. Tshwj xeeb: Cov neeg laus cov neeg mob uas muaj cov kab mob hauv zos lossis metastatic UC uas muaj cov kab mob FGFR3 lossis FGFR2 hloov pauv hloov pauv thiab tau txais yam tsawg kawg ib qho tshuaj kho mob platinum thaum lossis tom qab (xws li neoadjuvant lossis adjuvant platinum-muaj tshuaj kho hauv 12 lub hlis).


Nws tsim nyog hais tias Balversa yog thawj FGFR kinase inhibitor pom zoo los ntawm US FDA. Kev pom zoo ntxiv ntawm cov tshuaj' cov lus qhia yuav nyob ntawm qhov kev txheeb xyuas thiab kev piav qhia ntawm kev ua tau zoo ntawm kev kho mob hauv kev tshawb fawb pom tseeb. Yav dhau los, FDA tau tso cai rau Balversa breakthrough drug designation (BTD) thiab qhov tseem ceeb ntawm kev xaiv tshuaj nyob rau lub Peb Hlis 2018 thiab Cuaj Hlis 2018, feem.


Balversa tau pom zoo tshwj xeeb rau kev kho mob ntawm mUC cov neeg mob nrog FGFR3 lossis FGFR2 hloov pauv noob hauv lawv cov qog. Hauv Tebchaws Meskas, nws tau kwv yees tias ntau npaum li 3000 UC cov neeg mob nrog FGFR kev hloov pauv caj ces raug kuaj pom txhua xyoo. FGFR noob hloov tuaj yeem kuaj pom los ntawm FDA-pom zoo tus khub kuaj cov khoom siv. 5-xyoo kev ciaj sia rau cov neeg mob uas muaj theem IV mob qog noj ntshav qog nqaij hlav cancer uas nws mob qog noj ntshav tau kis mus rau qhov kawg ntawm lub cev tam sim no yog 6%.