Pemazyre (pemigatinib) tau pom zoo los ntawm EU, thiab Innovent tau qhia rau Suav teb!

Incyte tsis ntev los no tshaj tawm tias Cov European Commission (EC) tau pom zoo Pemazyre (pemigatinib), kev xaiv fibroblast kev loj hlob tau txais (FGFR) kinase inhibitor rau kev kho mob ntawm cov kev mob tom qab tau txais tsawg kawg ib qho kev kho mob rau cov neeg mob uas muaj nyob hauv zos lossis metastatic cholangiocarcinoma (cholangiocarcinoma) uas yog cov rov qab lossis rov ua dua tshiab, muaj FGFR2 kev sib txuas lossis rov tsim kho, thiab tsis tuaj yeem raug tshem tawm.

Thaum Lub Plaub Hlis 2020, Pemazyre yog thawj zaug tau txais kev pom zoo los ntawm Asmeskas FDA rau kev kho mob ntawm cov neeg mob hauv cheeb tsam siab lossis metastatic cholangiocarcinoma uas tau raug kho yav tas los, muaj FGFR2 fusion lossis rov tsim kho dua, thiab tsis tuaj yeem xa rov qab. Thaum Lub Peb Hlis 2021, Pemazyre tau pom zoo los ntawm Ministry of Health, Labour thiab Welfare (MHLW) ntawm Nyij Pooj rau kev kho mob ntawm cov neeg mob uas tsis muaj kev tiv thaiv cholangiocarcinoma uas tau mob hnyav ntxiv tom qab tau txais tshuaj anticancer kho mob thiab nqa FGFR2 fusion noob.

Nws tsim nyog teev tias Pemazyre yog thawj qhov thiab tsuas yog kho rau hom mob cholangiocarcinoma hauv Asmeskas, Nyij Pooj, thiab European Union. Cov tshuaj tuaj yeem tiv thaiv qhov kev loj hlob thiab kis tawm ntawm cov qog ntshav los ntawm kev thaiv FGFR2 hauv cov qog ntshav. Vim tias cholangiocarcinoma yog kev mob qog loj heev nrog kev kho mob tsis txaus ntseeg, Lub Chaw Kho Mob Pemazyre tau tso cai rau Chaw Kho Mob Me Nyuam Kho Mob, Cov Ntawv Muaj Tshuaj Kho Mob, Cov Tshuaj Ntsuam Xyuas Ua Ntej, thiab Tshuaj Ntsuam Xyuas Ua Ntej.

Incyte CEO Herve Hoppenot tau hais tias:" Kev pom zoo ntawm Pemazyre yog lub sijhawm tseem ceeb rau FGFR2-zoo cholangiocarcinoma cov neeg mob. Nov yog thawj zaug uas cov European Union tau muab txoj kev kho mob tshiab rau cov neeg mob no ntev tshaj kaum xyoo dhau los. Tsis muaj kev tu kom zoo hauv keeb kwm. Hauv qhov xwm txheej txheem, qhov kev zov me nyuam no tau ua kom pom kev them nqi siab kawg. Tam sim no peb tos ntsoov yuav ua haujlwm nrog txhua lub tebchaws hauv Tebchaws Europe kom ntseeg tau tias cov neeg mob uas tsim nyog tau txais txoj kev kho tshiab no sai li sai tau."

Pemazyre' s kev tswj hwm kev pom zoo hauv Tebchaws Meskas, Nyij Pooj, thiab European Union yog saib raws li cov ntaub ntawv raws txoj kev tshawb FIGHT-202. Txoj kev tshawb no tau coj los rau hauv cov neeg mob uas muaj lub siab loj hauv cheeb tsam lossis metastatic cholangiocarcinoma uas yav dhau los tau txais kev kho mob los soj ntsuam kev ua tau zoo thiab kev nyab xeeb ntawm Pemazyre. Cov txiaj ntsig ntawm txoj kev tshawb no tau tshaj tawm tsis ntev los no hauv European Society of Medical Oncology (ESMO) 2019 lub rooj sib tham. Cov ntaub ntawv qhia tau hais tias ntawm cov neeg mob nrog FGFR2 fusion lossis rov tsim kho dua (cohort A), kev soj ntsuam nruab nrab ntawm 15 lub hlis, tag nrho cov tshuaj ntawm Pemazyre monotherapy Tus nqi lus teb (ORR) yog 36% (thawj qhov kawg), thiab nruab nrab ntev ntawm teb (DoR) yog 7.49 lub hlis (theem siab kawg).

Hauv txoj kev tshawb fawb no, qhov tshwm sim tsis zoo tshaj plaws (TEAE) thaum kho yog qib 2 hyperphosphatemia (58.2%). Lwm qhov TEAEs ntau dua (txhua qib) pom nyob rau hauv ≥30% ntawm cov neeg mob yog cov plaub hau poob, raws plab, qaug zog, dysphagia, xeev siab, cem quav, cem quav, qhov ncauj qhuav, thiab tsis qab los. Feem ntau ntawm TEAE qib yog ≤ Qib 2. Ib qib ≥3 TEAE uas tshwm sim hauv ≥10% ntawm cov neeg mob yog hypophosphatemia.

Txawm hais tias cholangiocarcinoma yog suav tias yog ib tus kab mob tsis tshua muaj txiaj ntsig, qhov xwm txheej tau nce ntxiv rau 30 xyoo dhau los. Rau cov pab pawg ntawm cov neeg mob uas yav tas los tau txais kev kho mob ua ntej lossis kev phais mob, nrog cov kev xaiv tsawg thiab tus nqi nce siab dua, nws yog qhov kev txhawb nqa kom muaj lub hom phiaj kho tshiab. Cov ntaub ntawv los ntawm kev tshawb nrhiav FIGHT-202 qhia tau hais tias Pemazyre tuaj yeem coj kev cia siab tshiab rau cov neeg mob no.

Cholangiocarcinoma yog mob qog ntshav tsawg uas tshwm sim nyob rau hauv cov kua tsib lub cev thiab tuaj yeem raug cais raws li nws qhov keeb kwm thawj: kev mob siab rau cholangiocarcinoma (iCCA) tshwm sim hauv kev kho mob plab bras duct, thiab extrahepatic cholangiocarcinoma tshwm sim nyob rau hauv cov leeg ntshav ua ke. Cov neeg mob cholangiocarcinoma feem ntau yog nyob rau theem lig lossis theem ntawm kev tsis zoo thaum lawv kuaj tau. Qhov tshwm sim ntawm cholangiocarcinoma txawv ntawm cheeb tsam mus rau thaj av, thiab qhov tshwm sim ntawm North America thiab Europe yog 0.3-3.4 / 100,000. FGFR2 fusion lossis rov tsim kho tshwm sim yuav luag tag nrho hauv iCCA thiab tau pom hauv 10-16% ntawm cov neeg mob.

Fibroblast kev loj hlob tau txais (FGFR) ua lub luag haujlwm tseem ceeb hauv cov qog nqaij hlav loj, kev ciaj sia, tsiv teb tsaws thiab angiogenesis (kev tsim cov hlab ntshav tshiab). Kev sib tov, rov ua dua, hloov chaw thiab hloov kho cov noob hauv FGFR muaj kev cuam tshuam zoo nrog kev tshwm sim thiab tsim ntau yam qog.

Pemazyre-pemigatinib (FGFR inhibitor, duab duab: medchemexpress.cn)

Pemazyre' s cov tshuaj ua haujlwm pemigatinib yog cov muaj zog, xaiv, qhov ncauj me me tshuaj tiv thaiv kab mob tiv thaiv FGFR isomers 1, 2, thiab 3. Hauv kev tshawb nrhiav preclinical, pemigatinib tau lees tias muaj hwj chim thiab xaiv cov tshuaj muaj zog tiv thaiv qog hlwb nrog FGFR hloov ales.

Tam sim no, pemigatinib tab tom raug soj ntsuam hauv ntau qhov kev tshawb fawb los kho qog mob qog uas tau tsav los ntawm FGFR kev hloov pauv, suav nrog: cholangiocarcinoma (theem II FIGH-202, theem III FIGH-302), mob zais zis (theem II FIGH-201), mob pob txha Lub cev loj hlob (8p11 MPN, theem II FIGH-203), mob qog nqaij hlav-mob siab (mob qog-agnostic, theem II FIGHT-207), mob zais zis (kho thawj kab, theem II FIGH-205), thawj kab kev kho mob FGFR2 fusion lossis hnyav Cholangiocarcinoma (Theem III FIGH-302).

Thaum Lub Kaum Ob Hlis 2018, Innovent thiab Incyte tau mus txog qhov kev sib koom ua tswv yim thiab kev tso cai pom zoo kom txhawb kev soj ntsuam kev lag luam thiab kev ua lag luam ntawm peb cov tshuaj (itacitinib, parsaclisib, pemigatinib) hauv kev kho ib leeg los yog sib xyaw ua ke hauv Mainland Tuam Tshoj, Hong Kong, Macau thiab Taiwan. 化. Raws li cov lus cog tseg ntawm kev koom tes, Incyte yuav tau txais $ 40 lab daus las los ntawm kev them nyiaj los ntawm Cinda Bio, ntxiv rau qhov nyiaj thib ob $ 20 lab nyiaj tom qab xa thawj daim ntawv thov cov tshuaj tshiab hauv Tuam Tshoj hauv 2019. Tsis tas li ntawd, Incyte yuav tsim nyog rau cov peev txheej tsim kho kev them nqi txog $ 129 lab thiab kev lag luam peev nyiaj tau txog $ 202.5 lab.