Ono Tus Kws Kho Mob Braftovi peb-tshuaj pabcuam tau xa ib daim ntawv thov hauv Nyijpooj los kho BRAF V600E kev hloov pauv hloov cov neeg mob!

Ono Pharmaceutical tsis ntev los no tau tshaj tawm tias nws tau xa cov tshuaj tiv thaiv tshuaj tshwj xeeb Braftovi (binimetinib, 50 mg tshuaj ntsiav; MEK inhibitor) hauv kev sib xyaw nrog Mektovi (encorafenib, 15 mg ntsiav tshuaj; BRAF inhibitor) hauv Nyij Pooj. Cov ntawv thov ntxiv ntawm Erbitux (cetuximab, cetuximab, tiv thaiv tib neeg EGFR monoclonal antibody) rau kev kho mob ntawm qhov tsis muaj kev tiv thaiv qib siab lossis rov ua BRAF mutant colorectal cancer (CRC).

Daim ntawv thov yog raws cov txiaj ntsig ntawm lub ntiaj teb, xaiv ib qho, qhib-daim ntawv lo theem III kawm (BEACON CRC kawm). Txoj kev tshawb no tau ua rau cov neeg mob uas tsis muaj kev tiv thaiv, tau nce siab, lossis rov huam dua BRAF V600E hloov pauv CRC uas tau muaj kev vam meej yav dhau los tom qab tau txais ib lossis ob txoj kev kho mob, thiab tau soj ntsuam Braftovi ob-tshuaj tshuaj (Braftovi + Erbitux) thiab cov tshuaj peb Braftovi regimen (Braftovi + Erbitux + Mektovi), Erbitux ua ke nrog kev siv tshuaj irinotecan (tswj phiaj xwm) kev ua tau zoo thiab kev nyab xeeb.

Cov txiaj ntsig tau pom tias piv nrog pab pawg tswj hwm, tag nrho cov kev muaj sia nyob (OS) ntawm Braftovi peb-tshuaj yeeb tshuaj pab pawg tau ntev ntev ntawm cov lus (nruab nrab OS: 9.0 lub hlis vs 5.4 lub hlis; HR=0.52; 95% CI: 0.39-0.70; p< 0.0001).="" ib="" qho="" ntxiv,="" piv="" nrog="" pab="" pawg="" tswj="" hwm,="" braftovi="" peb-tshuaj="" pab="" pawg="" pom="" tau="" hais="" tias="" muaj="" kev="" txhim="" kho="" zoo="" nyob="" hauv="" cov="" hom="" phiaj="" teb="" (orr)="" (orr:="" 26.1%="" vs="" 1.9%;="">< 0.0001).="" hauv="" txoj="" kev="" tshawb="" fawb="" no,="" piv="" nrog="" pab="" pawg="" tswj="" hwm,="" ob="" pawg="" tshuaj="" yeeb="" tshuaj="" tseem="" ua="" rau="" pom="" kev="" txhim="" kho="" hauv="" os="" thiab="" orr.="" cov="" txiaj="" ntsig="" ntawm="" kev="" piav="" qhia="" tau="" pom="" tias="" hauv="" tag="" nrho="" cov="" pej="" xeem="" tshawb="" nrhiav,="" ob-tshuaj="" yeeb="" tshuaj="" thiab="" peb-tshuaj="" muaj="" txiaj="" ntsig="" zoo="" ib="" yam.="" hauv="" kev="" tshawb="" nrhiav,="" qhov="" tshuaj="" zaum="" thib="" ob="" thiab="" thib="" peb="" cov="" tshuaj="" yeeb="" yam="" tsis="" pom="" cov="" tshuaj="" lom="" mob="" uas="" tsis="" xav="">

Raws li cov txiaj ntsig ntawm txoj kev kawm no, Pfizer tau xa daim ntawv thov ntxiv mus rau US FDA xav tau kev pom zoo rau Braftovi tshuaj thib ob cov tshuaj (Braftovi + Erbitux) rau BRAF V600E kev hloov pauv-zoo, kev mob ua paug txha caj qaum mob qog nqaij hlav (mCRC) Kev Kho Mob Cov. Tam sim no, daim ntawv thov cov ntaub ntawv thov ntxiv tau soj ntsuam los ntawm FDA, thiab hnub tim lub hom phiaj rau Daim Ntawv Qhia Tshuaj Siv Tshuaj (PDUFA) yog lub Plaub Hlis 2020.

Thaum Lub Kaum Ib Hlis 2019, European Tshuaj Noj Tshuaj (EMA) kuj tau pib ua qhov kev tshuaj ntsuam xyuas los saib xyuas Chav Kawm II hloov daim ntawv thov xa los ntawm Fab Kis cov chaw muag tshuaj Pierre Fabre rau Braftovi ob-tshuaj kev kho mob los kho BRAF V600E mutant mCRC cov neeg mob.

Braftovi' s lub chaw tshuaj muaj txiaj ntsig binimetinib yog qhov ncauj tshuaj me me BRAF inhibitor, thiab Mektovi' s lub chaw tshuaj muaj txiaj encorafenib yog qhov ncauj me me molecule MEK inhibitor. MEK thiab BRAF yog ob qhov tseem ceeb protein kinases hauv MAPK cov kev taw qhia (RAS-RAF-MEK-ERK). Cov kev tshawb fawb pom tau tias txoj kev no tswj hwm ntau cov haujlwm tseem ceeb ntawm tes suav nrog kev nthuav dav ntawm tes, kev sib txawv, kev ciaj sia, thiab angiogenesis. Hauv ntau cov qog nqaij hlav, xws li melanoma, mob plab hnyuv taum, thiab mob qog noj ntshav, cov protein nyob hauv cov phiajcim no tau pom tias tau ua haujlwm tsis zoo.

Hauv Tebchaws Meskas, Braftovi + Mektovi kev sib xyaw tau pom zoo rau kev tsis tuaj yeem lossis metastatic melanoma nrog BRAF V600E lossis BRAF V600K kev sib hloov. Braftovi tsis haum rau kev kho mob ntawm hom tsiaj qus BRAF melanoma. Hauv Tebchaws Europe, kev sib xyaw ua ke tau txais kev pom zoo rau cov neeg laus uas tsis tuaj yeem tiv thaiv lossis metastatic melanoma nrog BRAF V600 hloov tau. Hauv Nyij Pooj, kev sib xyaw ua ke tau pom zoo rau BRAF-mutated tsis tuaj yeem tiv thaiv tus mob melanoma.

Braftovi thiab Mektovi tau tshawb pom thiab tsim los ntawm Array BioPharma. Thaum Lub Rau Hli 2019, Pfizer tau txais Array BioPharma rau $ 11.4 nphom. Tam sim no, Pfizer muaj txoj cai tshwj xeeb rau ob yam tshuaj hauv Tebchaws Meskas thiab Canada. Thaum lub Tsib Hlis 2017, Ono Pharmaceuticals tau tso cai tshwj xeeb txoj cai ntawm 2 tshuaj nyob rau Nyiajpoom Teb thiab Kaus Lim Qab Teb los ntawm Array BioPharma, lub tuam txhab Israeli chaw muag tshuaj Medison tau tso cai tshwj xeeb ntawm 2 tshuaj nyob hauv tebchaws Israel, thiab Fabkis Pierre Fabre Group (Fabkis Fabre) tau tso cai 2 Lub cov cai tshwj xeeb ntawm cov tshuaj no hauv txhua lub tebchaws, suav nrog Europe, Latin America thiab Asia (tshwj tsis yog Nyij Pooj thiab Kaus Lim Qab Teb).