Uhlalutyo lwedatha luqala kuphononongo lomhlaza ophambili we-metastatic colorectal

I-Isofol Medical AB namhlanje ibhengeze ukuqaliswa kohlalutyo lwedatha kwiziko lehlabathi, iSigaba sesi-III sophononongo lwe-AGENT oluphanda i-arfolitixorin ludityaniswe ne-5-FU, i-oxaliplatin kunye ne-bevacizumab kumhlaza ophambili, we-metastatic colorectal (mCRC). Ukukhaba kwenkqubo yokufunda kulandela iingxoxo kunye ne-US Food and Drug Administration (FDA) kwimithetho yokuhlolwa kunye nenani leziganeko ze-PFS ezifunekayo ukuqala ukuqokelela idatha kunye nohlalutyo. I-Isofol iya kugqiba inani leziganeko ze-PFS zokunqunyulwa, eziza kuqwalaselwa yi-FDA ngexesha lokuphononongwa kwe-NDA.

Ukuphononongwa ngenkuthalo kweenketho ze-SAP ehlaziyiweyo kwakhokelela kwiingcamango ezintsha zokuhlalutya idatha. I-Isofol ngoku iya kungenisa ukuhlalutya kophando olusekelwe kwizigulane ze-490 ezibhaliswe kwisifundo (izigulane zaseJapan ngaphambili kwi-adendum eyongeziweyo kwisifundo esiphambili) kwaye zombini imithetho yokuqala kunye nemitsha yokuhlola iya kufakwa kwiSicelo esitsha seDrug (NDA). Ukunyaniseka kweSifundo se-AGEN sihlala somelele. I-Isofol igxininise ngokuqinileyo kuhlalutyo olubanzi kwaye ilindele ukuba kuya kuthatha iinyanga ezimbini ukuya kwezine ukususela ekuqaleni kokuhlalutya ngaphambi kokuba iziphumo eziphezulu zichazwe.

Umhlaza we-Colorectal ungoyena nobangela wesithathu okhokelayo womhlaza kwihlabathi kwaye ungowesibini unobangela wokufa komhlaza ngokufa phantse kwesigidi esinye ngo-2020. Inkqubela phambili yakutsha nje kunyango lwe-mCRC igxile kunyango olujoliswe kuluntu olukhethiweyo kwaye isafuna indibaniselwano ne-5-FU esekwe. iirejimeni zechemotherapy ngeziphumo ezinentsingiselo ngexesha lonyango. Oku kuthetha ukuba phantse zonke izigulane zomgca wokuqala we-mCRC ziya kufumana i-folate equlethe irejimeni njengenxalenye yomgangatho wokhathalelo. 

"Kukho isidingo esinzulu esingafezekanga kumhlaza we-metastatic colorectal, kodwa bambalwa amayeza afundwayo ukuze ancede uninzi lwezigulane kunye neethagethi ezithile," kusho u-Ulf Jungnelius, i-CEO ye-Isofol. "Kwi-Isofol, sigxile ngokukodwa ekuchongeni uhlengahlengiso olulula nolusebenzayo ngakumbi lomgangatho wokhathalelo ukuze sinciphise ngakumbi umthwalo wethumba kunye nokwandisa ubomi bezigulana ezininzi." 

Kwiminyaka eyi-40 edlulileyo, i-5-FU ilawulwa ngaphezu kweepesenti ze-70 zezigulane ezine-mCRC ngokudibanisa ne-leucovorin / levoleucovorin kunye nezinye i-cytostatics. Nangona ezi zidibaniso, kuphela inxalenye encinci yezigulane eziye zifaneleke ukuhlinzwa ngokuhlinzwa (eziphezulu kwisifo esilinganiselwe sesibindi), indlela esebenzayo yokufezekisa iziphumo ezizinzileyo. Kwaye kuphela iipesenti ezili-10 zabantu abahlala ne-mCRC abasinda kwiminyaka emihlanu emva kokuxilongwa. I-Arfolitixorin yeyokuqala kunye ne-folate esebenzayo ngokukhawuleza exhasa i-5-FU, iphucula isiphumo sayo sokubulala ithumba.