Cov Koom Tes hauv Cinda Bio Incyte lub Zog FGFR Kinase Tus Txwv Chaw Pemazyre (pemigatinib) Tau Pom Zoo Los ntawm Asmeskas FDA!

Tsis ntev los no Cinda Bio Partners Incyte tshaj tawm tias Tsoomfwv Saib Xyuas Khoom Noj thiab Tshuaj (FDA) tau pom zoo Pemazyre (pemigatinib), uas yog xaiv cov kev loj hlob fibroblast loj tau txais (FGFR) kinase inhibitor nrog kev taw qhia ntawm: Nws yog siv los kho cov neeg mob hauv zos metastatic cholangiocarcinoma uas tau raug kho yav tas los, muaj FGFR 2 sib txuas lossis rov kho dua, thiab tsis tuaj yeem raug tshem tawm. Pemazyre raug pom zoo raws li cov txheej txheem kev pom zoo sai thiab cov txheej txheem pom zoo ua ntej raws li cov lus teb tas nrho (ORR) thiab lub sijhawm teb (DOR) cov ntaub ntawv. Txuas ntxiv kev pom zoo rau qhov ntsuas no yuav nyob ntawm kev siv tau thiab kev pab soj ntsuam los ntawm kev piav qhia txog kev sim lub siab. Tam sim no, Pemazyre tseem tab tom tshuaj xyuas los ntawm European Medicines Agency (EMA).

Nws tsim nyog teev tias Pemazyre yog thawj zaug thiab tsuas yog FDA pom zoo siv tshuaj rau kev kho mob cholangiocarcinoma, uas tuaj yeem tiv thaiv kev loj hlob thiab sib kis ntawm cov qog ntshav los ntawm kev thaiv FGFR 2 hauv cov qog hlwb. 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 cov menyuam ntsuag tsis muaj peev xwm, cov tshuaj ua kom dhau, thiab kev tshuaj xyuas ua ntej.

Qhov kev pom zoo no yog raws cov ntaub ntawv los ntawm kev kawm txog TSWV-20 2 . Txoj kev tshawb no tau ua nyob rau hauv cov neeg mob uas muaj kab mob hauv cheeb tsam lossis kev tiv thaiv kab mob cholangiocarcinoma uas yav dhau los raug kho los soj ntsuam kev ua tau zoo thiab kev nyab xeeb ntawm Pemazyre. Cov txiaj ntsig ntawm txoj kev tshawb no tau nyuam qhuav luam tawm ntawm European Society of Medical Oncology (ESMO) 2019 lub rooj sib tham. Cov ntaub ntawv qhia tau hais tias ntawm cov neeg mob nrog FGFR 2 fusion lossis rov tsim kho dua (cohort A), qhov nruab nrab taug qab yog 15 hli. Cov lus teb tau (ORR) yog 36% (thawj qhov xaus), thiab qhov nruab nrab ntawm kev teb (DoR) yog 9. 1 lub hlis (theem nrab xaus).

Hauv qhov kev tshawb fawb no, qhov xwm txheej tsis zoo yog tswj tau thiab xwm yeem nrog Pemazyre' s mechanism ntawm kev nqis tes ua. Hauv cov neeg mob uas tau txais Pemazyre, cov kev mob tshwm sim ntau tshaj plaws hauv ≥ 20% ntawm cov neeg mob yog hyperphosphatemia thiab hypophosphatemia (electrolyte cuam tshuam), plaub hau ploj (alopecia areata), raws plab, ntsia hlau lom, nkees, saj cuam tshuam, xeev siab, cem quav , mob plab (mob lossis mob hauv qhov ncauj), qhov muag qhuav, qhov ncauj qhuav, tsis qab los noj mov, ntuav, mob caj dab, mob plab, mob nraub qaum, thiab tawv nqaij qhuav. Kev mob rau cov leeg kuj yog ib qho kev pheej hmoo rau Pemazyre.

Dr. Ghassan Abou-Alfa, MD, Memorial Sloan-Kettering Cancer Center, hais tias:" Txawm hais tias cholangiocarcinoma yog suav tias yog kab mob tsawg, qhov xwm txheej tau nce siab dhau los 30 xyoo. Rau cov neeg uas tau txais kev kho mob ua ntej lossis kev phais mob Rau cov pab pawg neeg mob uas muaj kev xaiv tsawg thiab cov kev mob huam tuaj ntau dua, muaj cov hom phiaj tshiab kho tau zoo heev thiab yuav coj kev cia siab tshiab rau cov neeg mob."

Cholangiocarcinoma yog ib qho mob kheesxaws tsawg tsawg, uas tuaj yeem raug cais raws li nws qhov keeb kwm thawj: mob cholangiocarcinoma (iCCA) tshwm sim hauv kev mob plab hauv lub plab, thiab cov kab mob ntxiv cholangiocarcinoma tshwm sim hauv kev kho mob ntxiv mus. Cov neeg muaj mob cholangiocarcinoma feem ntau yog nyob rau theem lig lossis lig nrog kev mob tsis zoo thaum lub sijhawm kuaj mob. Qhov tshwm sim ntawm cholangiocarcinoma sib txawv raws cheeb tsam, thiab qhov tshwm sim ntawm North America thiab Europe yog 0.3-3. 4 / 100000. FGFR 2 fusion lossis rov tsim dua tshwm sim yuav luag tag nrho hauv iCCA thiab tau pom hauv 10-16% ntawm cov neeg mob.

Fibroblast kev loj hlob tau receptor (FGFR) ua lub luag haujlwm tseem ceeb hauv qog nqaij hlav loj zuj zus, kev ciaj sia, tsiv teb tsaws thiab angiogenesis (neovascularization). Kev sib tov, rov ua haujlwm, hloov chaw thiab hloov kho cov noob hauv FGFR yog ze ze rau qhov tshwm sim thiab tsim ntawm ntau cov qog.

Pemazyre' s lub chaw tshuaj ua haujlwm, pemigatinib, yog lub zog, xaiv, qhov ncauj me me rau cov tshuaj tiv thaiv kab mob tawm tsam FGFR isomers 1, 2, thiab 3. Hauv cov kev tshawb fawb preclinical, pemigatinib tau pom tias muaj lub zog thiab xaiv cov chaw muag tshuaj tiv thaiv cov qog nqaij hlav cancer uas tau dhau los hloov FGFR noob.

pemigatinib (FGFR inhibitor, duab qhov chaw: medchemexpress.cn)

Tam sim no, pemigatinib tab tom raug soj ntsuam hauv ntau qhov kev tshawb fawb los kho cov qog mob qog ua rau los ntawm FGFR kev hloov pauv, suav nrog: cholangiocarcinoma (theem II FIGHT-202, theem III FIGHT-302), mob zais zis (theem II FIGHT-201), mob hlwb pob txha Proliferative. mob qog (8 p 11 MPN, theem II FIGHT-203), mob qog nqaij hlav agnostic (qog-agnostic, theem II FIGHT-207), mob zais zis (kho thawj kab, theem II FIGHT-205) ), ua ntej kho kab mob FGFR 2 fusion lossis rov mob dua Cholangiocarcinoma (theem III FIGHT-302).

Thaum Lub Kaum Ob Hlis 2018, Cinda Biotechnology thiab Incyte tau mus txog txoj kev koom tes ua tswv yim thiab kev tso cai pom zoo los txhawb kev txhim kho kev kho mob ntawm cov tshuaj ib leeg lossis kev sib koom ua ke ntawm peb cov tshuaj (itacitinib, parsaclisib, pemigatinib) hauv Suav teb suav thiab Hong Kong, Macau thiab Taiwan Thiab Kev Lag Luam. Raws li cov nqe lus ntawm kev sib koom tes pom zoo, Incyte yuav tau txais kev them nqi qis dua $ 40 lab los ntawm Cinda Biotechnology thiab thib ob $ 20 lab nyiaj them tom qab thawj daim ntawv thov rau cov tshuaj tshiab hauv Suav teb hauv 2019. Ib qho ntxiv, Incyte yuav tsim nyog txog $ 129 lab hauv cov peev txheej txhim kho, thiab ntau txog $ 202. 5 lab hauv cov peev txheej lag luam loj.