Pemazyre (pemigatinib), lub zog FGFR kinase inhibitor, yuav pom zoo sai sai hauv EU

Incyte tsis ntev los no tau tshaj tawm tias Pawg Neeg Saib Xyuas Kev Noj Tshuaj hauv Tebchaws Europe (EMA) rau Cov Khoom Siv Tshuaj rau Cov Neeg Siv (CHMP) tau tshaj tawm cov lus pom zoo hais txog kev pom zoo ntawm Pemazyre (pemigatinib), uas yog xaiv tau fibroblast kev loj hlob tau txais receptor FGFR kinase inhibitors siv los kho cov neeg mob uas nyob hauv ib cheeb tsam siab lossis metastatic cholangiocarcinoma (cholangiocarcinoma) uas muaj mob rov huam lossis rov huam dua, FGFR2 fusion lossis rov kho dua tshiab, thiab tsis tuaj yeem raug tshem tawm tom qab tau txais kev kho mob tsawg kawg. Yog tias tau txais kev pom zoo, Pemazyre yuav dhau los ua Tebchaws Europe' s thawj lub hom phiaj kho rau qhov ntsuas no. Tam sim no, CHMP cov tswv yim yuav muab xa mus rau European Commission (EC) rau kev tshuaj xyuas, uas yuav tsum ua qhov kev txiav txim siab zaum kawg li ntawm 2 lub hlis.

Thaum Lub Plaub Hlis 2020, Tsoom Fwv Teb Chaws Asmeskas FDA tau pom zoo Pemazyre rau kev kho mob hauv cheeb tsam qib siab lossis metastatic cholangiocarcinoma cov neeg mob uas tau raug kho yav tas los, muaj FGFR2 fusion lossis rov kho dua tshiab, thiab tsis tuaj yeem xa rov tuaj. Pemazyre tau txais kev pom zoo nyob rau hauv kev ua kom tiav kev pom zoo thiab cov txheej txheem pom zoo ua ntej raws li cov lus teb tag nrho (ORR) thiab lub sijhawm teb (DOR) cov ntaub ntawv. Txuas ntxiv kev pom zoo rau qhov ntsuas no yuav yog los ntawm kev txheeb xyuas qhov tseeb thiab raug pov thawj ntawm cov kev pab kho mob hauv kev lees paub tseeb. piav qhia.

Nws tsim nyog teev tias Pemazyre yog thawj qhov thiab tsuas yog tsom cov tshuaj pom zoo los ntawm Asmeskas FDA rau kev kho mob ntawm cholangiocarcinoma. Cov tshuaj no tuaj yeem tiv thaiv kev loj hlob thiab nthuav tawm 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, Pemazyre tau yav dhau los tau tso cai rau tus tub ntsuag txoj cai, yeeb tshuaj dhau los, thiab tshuaj xyuas qhov muaj feem.

Tebchaws Asmeskas FDA pom zoo thiab cov kev soj ntsuam zoo ntawm EU CHMP yog saib raws cov ntaub ntawv ntawm kev kawm txog FIGHT-202. Txoj kev tshawb no tau ua rau cov neeg mob hauv cheeb tsam ua ntej 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), qhov nruab nrab taug qab li 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 9.1 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 ua. Hauv cov neeg mob kho nrog Pemazyre, cov kev mob tshwm sim ntau tshaj plaws uas tshwm sim hauv ≥20% ntawm cov neeg mob yog hyperphosphatemia thiab hypophosphatemia (electrolyte cuam tshuam), alopecia (alopecia areata), raws plab, ntsia hlau lom, nkees, dysgeusia, 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 pob txha, mob plab, mob nraub qaum thiab ua kom tawv nqaij qhuav. Qhov muag mob toxicity tseem muaj kev pheej hmoo rau Pemazyre.

Txawm hais tias cholangiocarcinoma yog suav hais tias yog ib tus kab mob tsis tshua muaj tshwm sim, 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 thawj zaug lossis kev phais mob tom qab muaj kev xaiv tsawg dua thiab muaj qhov rov zoo dua, nws tau txais kev txhawb siab 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 (cholangiocarcinoma) yog ib tus kabmob kheesxaws tsawg tsawg uas tuaj yeem raug cais raws li nws keeb kwm: qhov mob cholangiocarcinoma (iCCA) tshwm sim hauv cov leeg ntshav mob mus rau sab hauv. Cov neeg mob cholangiocarcinoma feem ntau yog nyob rau theem lig lossis lig dua nrog kev mob 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 haujlwm, hloov chaw thiab hloov kho cov noob hauv FGFR yog ze ze rau qhov tshwm sim thiab nthuav tawm ntau cov qog.

Pemazyre' s cov tshuaj ua haujlwm, pemigatinib, yog lub 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 paub tias muaj cov muaj zog thiab xaiv cov tshuaj muaj zog tiv thaiv qog hlwb nrog FGFR noob kev hloov.

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 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 hlwb cov hlav hlav loj (8p11 MPN, Ntu II FIGH-203), mob qog nqaij hlav-mob siab (hom qog-agnostic, Theem II FIGH-207), mob zais zis (kho thawj kab, Ntu II FIGH-205), kab thawj 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 nqe lus ntawm kev koom tes sib cog lus, Incyte yuav tau txais $ 40 lab daus las los ntawm kev them nyiaj los ntawm Innovent thiab qhov nyiaj thib ob $ 20 lab nyiaj tom qab thawj daim ntawv thov kev siv tshuaj tshiab tau xa hauv Suav xyoo 2019. Ntxiv rau, Incyte yuav tsim nyog rau lub peev xwm kev txhim kho cov nqi tseem ceeb ntawm cov nyiaj tau txog $ 129 lab thiab muaj peev xwm lag luam kev them nqi txog $ 202.5 lab.