Isofol Medical AB nhasi yakazivisa kutanga kwekuongororwa kwedata kweakawanda-center, yepasi rose Phase III AGENT Kudzidza achiongorora arfolitixorin musanganiswa ne5-FU, oxaliplatin uye bevacizumab mune advanced, metastatic colorectal cancer (mCRC). Kutangwa kwemaitiro ekuverenga kunotevera nhaurirano neUS Food and Drug Administration (FDA) pamusoro pemitemo yekuongorora uye huwandu hwezviitiko zvePFS zvinodiwa kutanga kuunganidza nekuongorora. Isofol ichatarisa huwandu hwezviitiko zvePFS zvekuchekwa, izvo zvinozotariswa neFDA panguva yekuongorora kweNDA.
Kuongorora kwekushingaira kwezvisarudzo zveSAP yakagadziridzwa yakatungamirira kune zvitsva zvekuongorora deta. Isofol ikozvino ichaendesa kuongororwa kwechidzidzo kwakavakirwa pavarwere ve490 vakanyoreswa muchidzidzo (varwere vekuJapan vaimbove mukuwedzera kune chidzidzo chikuru) uye ese ari maviri ekutanga uye matsva ekudzora mitemo ichaverengerwa muNew Drug Application (NDA). Kuvimbika kweChidzidzo cheAGENT kunoramba kwakasimba. Isofol yakanyatsotarisana nekuongorora kwakadzama uye inotarisira kuti ichatora mwedzi miviri - mina kubva pakutanga kwekuongorora kusati kwasvika migumisiro yepamusoro inogona kuziviswa.
Colorectal cancer ndiyo yechitatu inotungamira kukonzeresa cancer munyika uye yechipiri inotungamira kukonzera kufa kwegomarara nerufu rwunosvika miriyoni imwe muna 2020. Kufambira mberi kwazvino mukurapwa kwemCRC kwakanangana nekurapa kwakanangwa kwevakasarudzwa vanhu uye vachiri kuda kusanganiswa ne5-FU yakavakirwa. chemotherapy regimens yemigumisiro ine chinangwa panguva yekurapa. Izvi zvinoreva kuti vangangoita vese mutsara wekutanga mCRC varwere vanogashira folate ine regimen sechikamu cheyero yekuchengeta.
"Pane kudiwa kwakanyanya kusingagutsikane mune metastatic colorectal cancer, asi vashoma marapirwo ari kuongororwa kuti abatsire ruzhinji rwevarwere maringe nezvinangwa chaizvo," akadaro Ulf Jungnelius, CEO weIsofol. "KuIsofol, isu tanga takatarisana nekuona nzira iri nyore uye inoshanda yemazuva ano yehutano hwekutarisira kuwedzera kudzikisa bundu mutoro uye kuwedzera hupenyu hwevamwe varwere."
Kwemakore makumi mana apfuura, 40-FU yakashandiswa kune vanopfuura 5 muzana yevarwere vane mCRC pamwe chete neleucovorin / levoleucovorin nemamwe cytostatics. Pasinei nekubatanidzwa uku, chikamu chiduku chete chevarwere vanova vakakodzera kuvhiyiwa resection (yakakwirira muchirwere chechiropa-chishoma), nzira inobudirira yekuwana migumisiro yakagadzikana. Uye chete 70 muzana yevanhu vanogara nemCRC vanorarama makore mashanu mushure mekuongororwa. Arfolitixorin ndiyo yekutanga uye inokurumidza kushanda folate iyo inosimbisa 10-FU, ichiwedzera kuuraya kwayo bundu.
ZVOKUBVA MUNYAYA INO:
- Isofol will now submit analyses of the study based on 490 patients enrolled in the study (Japanese patients previously in addendum added to main study) and both the original and new censoring rules will be included in the New Drug Application (NDA).
- Colorectal cancer is the third leading cause of cancer in the world and the second leading cause of cancer mortality with almost one million deaths in 2020.
- Isofol is firmly focused on a comprehensive analysis and expects it will take two – four months from the start of the analysis before top-line results can be communicated.
