US FDA tau tso cai rau arfolitixorin ceev khiav kev tsim nyog

Isofol Medical AB tsis ntev los no tshaj tawm tias US Food and Drug Administration (FDA) tau tso cai Modufolin (arfolitixorin, [6R]-5,10-methylenetetrahydrofolate, [6R]-MTHF) fast track qualification (FTD) rau siv rau kev kho mob metastatic. mob qog nqaij hlav hauv plab (mCRC). Arfolitixorin yog ib qho kev sib xyaw tshiab raws li folic acid, uas yog siv los txhim kho kev ua tau zoo thiab txo cov kev mob tshwm sim ntawm cov tshuaj tiv thaiv metabolite hauv kev kho mob qog noj ntshav. Isofol tau kos npe rau daim ntawv cog lus tshwj xeeb thoob ntiaj teb nrog Merck KGaA los tsim thiab ua lag luam arfolitixorin rau kev qhia txog oncology.

Arfolitixorin yog lub luag haujlwm tseem ceeb hauv metabolite ntawm cov tshuaj folic acid uas siv dav hauv leucovorin thiab levoleucovorin. Folinic acid thiab levofolinic acid yuav tsum tau hloov mus rau hauv daim ntawv nquag [6R]-MTHF hauv lub cev kom ua tau zoo. Qhov no nyob ntawm, piv txwv li, genetic susceptibility. Tsis yog txhua tus neeg mob ua rau qhov kev ua haujlwm no. Cov kev tshawb fawb tau pom tias peb-quarters ntawm mCRC cov neeg mob tsis muaj peev xwm hloov pauv leucovorin thiab levofolic acid, thiab qhov kev vam meej tsis muaj sia nyob (PFS) tau txo qis dua piv rau cov neeg mob uas muaj peev xwm hloov tau zoo.

Arfolitixorin yog ib qho tshuaj rau kev kho mob ntawm CRC siab heev. Txij li nws tsis tas yuav muaj kev ua kom cov metabolism hauv kev ua haujlwm, arfolitixorin tuaj yeem tsim nyog rau txhua tus neeg mob uas muaj CRC siab heev, tsis hais nws lub peev xwm los qhib folic acid.

Fast Track Qualification (FTD) lub hom phiaj txhawm rau txhawm rau txhawm rau txhim kho tshuaj thiab tshuaj xyuas sai rau cov kab mob loj los daws cov kev xav tau kev kho mob hnyav hauv cov chaw tseem ceeb. Tau txais kev tsim nyog tau txais txiaj ntsig sai rau cov tshuaj hauv kev txhim kho txhais tau tias cov tuam txhab tshuaj tuaj yeem cuam tshuam nrog FDA ntau dua thaum lub sijhawm tshawb fawb thiab txhim kho. Tom qab xa daim ntawv thov kev lag luam, lawv tsim nyog tau txais kev pom zoo nrawm dua thiab kev tshuaj xyuas ua ntej yog tias lawv ua tau raws li cov qauv tsim nyog. Tsis tas li ntawd, lawv kuj tsim nyog rau kev tshuaj xyuas dov.

Hauv Tebchaws Meskas, CRC yog qhov thib ob ua rau mob qog noj ntshav thiab thib peb hom mob qog noj ntshav. Hais txog kev kho mob mCRC, muaj qhov xav tau kev kho mob tseem ceeb rau cov kev kho mob tshiab thiab zoo dua. FDA tau tso cai rau arfolitixorin FTD raws li cov tshuaj' lub peev xwm los daws cov kev xav tau kev kho mob tseem ceeb ntawm mCRC.

Raws li thawj thiab tsuas yog ntshiab folic acid metabolically active tshuaj ([6R]-MTHF) uas nce 5-fluorouracil (5-FU) cytotoxicity, arfolitixorin yog tam sim no tau ua nyob rau hauv lub ntiaj teb no tseem ceeb Phase 3 AGENT txoj kev tshawb no (NCT03750786) soj ntsuam. Txoj kev tshawb no yuav tsum ua kom tiav hauv 2022. Tom qab ntawd, Isofol npaj yuav xa daim ntawv thov kev lag luam mus rau US FDA thiab EU EMA, thiab xav tias yuav ua lag luam thaum ntxov li 2023.

Ulf Jugnelius, CEO ntawm Isofol, tau hais tias:" Peb zoo siab heev uas FDA tau tso cai rau peb cov neeg siv tshuaj yeeb tshuaj arfolitixorin ceev ceev raws li txoj cai. Qhov no yog qhov muaj zog sab nraud lees paub txog cov txiaj ntsig zoo ntawm arfolitixorin hauv kev kho mob ntawm mCRC, kab mob loj heev. Peb qhov chaw kho mob tom ntej no yog Achieve 300 cov xwm txheej tsis muaj sia nyob tsis muaj sia nyob hauv Phase 3 AGENT txoj kev tshawb fawb, thiab tom qab ntawd tshem tawm cov ntaub ntawv kom peb tuaj yeem txheeb xyuas thiab nthuav tawm cov txiaj ntsig saum toj kawg nkaus hauv thawj ib nrab xyoo 2022. FTD kev tsim nyog yuav cia peb koom tes. nrog FDA ntau zaus, txhawm rau txhim kho txoj kev txhim kho txuas ntxiv ntawm arfolitixorin, thiab yuav ua rau nws yog thawj cov tshuaj tshiab los txhim kho tus qauv kev saib xyuas rau mCRC hauv ntau dua 40 xyoo."