Kusanthula kwa data kumayamba pophunzira za khansa yapamwamba ya metastatic colorectal

Isofol Medical AB lero yalengeza za kuyambika kwa kusanthula kwa data kwa Multi-center, Global Phase III AGENT Study yofufuza arfolitixorin kuphatikiza 5-FU, oxaliplatin ndi bevacizumab yapamwamba, metastatic colorectal cancer (mCRC). Kuyambika kwa ndondomeko yowerengera kumatsatira zokambirana ndi US Food and Drug Administration (FDA) pa malamulo owunika komanso kuchuluka kwa zochitika za PFS zomwe zimayenera kuyambitsa kusonkhanitsa ndi kusanthula deta. Isofol iwonetsa kuchuluka kwa zochitika za PFS zodulidwa, zomwe zidzaganiziridwa ndi FDA pakuwunika kwa NDA.

Kuwunika mwakhama kwa zosankha za SAP yosinthidwa kunayambitsa malingaliro atsopano pofufuza deta. Isofol tsopano ipereka kusanthula kwa kafukufukuyu kutengera odwala 490 omwe adalembetsa nawo kafukufukuyu (odwala aku Japan omwe adawonjezeredwa kale kumaphunziro akulu) ndipo malamulo onse oyambilira komanso atsopano owunikira adzaphatikizidwa mu New Drug Application (NDA). Kukhulupirika kwa Phunziro la AGENT kumakhalabe kolimba. Isofol imayang'ana kwambiri pakuwunika kwatsatanetsatane ndipo ikuyembekeza kuti idzatenga miyezi iwiri - inayi kuyambira chiyambi cha kusanthula zisanachitike zotsatira za mzere wapamwamba.

Khansara ya colorectal ndi yachitatu yomwe imayambitsa khansa padziko lonse lapansi komanso yachiwiri yomwe imayambitsa kufa kwa khansa ndi kufa pafupifupi miliyoni miliyoni mu 2020. Kupita patsogolo kwaposachedwa kwa chithandizo cha mCRC kwayang'ana kwambiri pamankhwala omwe amawathandizira anthu osankhidwa ndipo amafunabe kuphatikiza ndi 5-FU yochokera. mankhwala a chemotherapy kuti apeze zotsatira zabwino panthawi ya chithandizo. Izi zikutanthauza kuti pafupifupi odwala onse oyamba a mCRC adzalandira folate yokhala ndi regimen monga gawo la chisamaliro choyenera. 

"Pali kusowa kwakukulu kosakwanira mu khansa yamtundu wa metastatic, komabe mankhwala ochepa omwe akuphunziridwa kuti apindule odwala ambiri motsutsana ndi zolinga zenizeni," adatero Ulf Jungnelius, CEO wa Isofol. "Ku Isofol, takhala tikuyang'ana kwambiri pakuzindikira njira yosavuta komanso yothandiza kwambiri ya chisamaliro kuti muchepetse chotupa ndikuwonjezera moyo wa odwala ambiri." 

Kwa zaka 40 zapitazi, 5-FU yaperekedwa kwa odwala oposa 70 peresenti ya odwala omwe ali ndi mCRC kuphatikiza leucovorin/levoleucovorin ndi ma cytostatics ena. Ngakhale kuphatikizikaku, ndi gawo lochepa chabe la odwala omwe ali oyenerera kuchitidwa opaleshoni (pamwamba pa matenda a chiwindi), njira yabwino yopezera zotsatira zokhazikika. Ndipo 10 peresenti yokha ya anthu omwe ali ndi mCRC amakhala ndi moyo zaka zisanu atazindikira. Arfolitixorin ndiye folate yoyamba komanso yogwira nthawi yomweyo yomwe imathandizira 5-FU, kukulitsa mphamvu yake yopha chotupa.