Ngomhlaka-7 kuNhlolanja 2025, iSichuan Kelun-Biotech Biopharmaceutical yamemezela ukuvunyelwa kwe-Cetuximab N01 Injection yayo yi-National Medical Products Administration yokwelapha umdlavuza we-colorectal osakazeke kabanzi (mCRC) eShayina.
Ukuvunyelwa kusekelwe ocwaningweni olukhulu lwezokwelapha lwesigaba sesi-3 olubonisa ukulingana komuthi ekusebenzeni kahle nasekuphepheni kokwelashwa okukhona, okungenzeka kwandise ukufinyeleleka kokwelashwa kwe-mCRC eShayina lapho izinga lokutheleleka kanye nokufa likhuphuka khona.
Ucwaningo luhlanganise iziguli ezingu-688, futhi imiphumela ibonise ukuthi uhlelo lwe-chemotherapy oluhlanganisiwe lwe-cetuximab N01 lwalulingana ngokwezokwelapha ngesilinganiso sokuphendula esiqondile (ORR) uma kuqhathaniswa ne-cetuximab injection (Erbitux) combined chemotherapy (ORR). Isilinganiso sokuphendula esiqondile (ORR) se-cetuximab N01 kanye ne-cetuximab injection (Erbitux) sasingu-71.0% kanye no-77.5%, ngokulandelana. Kwakungekho mehluko obalulekile ngokwezokwelapha noma ngokwezibalo esikhathini sokuphendula (DoR) kanye nokusinda okungenamkhawulo (PFS) phakathi kwe-cetuximab N01 kanye ne-cetuximab injection (Erbitux), kanye nokusinda okungenamkhawulo okungenamkhawulo kwezinyanga ezingu-10.9 kanye nezinyanga ezingu-10.8, ngokulandelana.
Ngokuphathelene nokuphepha, lesi sivivinyo somtholampilo esikhulu sesigaba III esilawulwa ikhanda nekhanda siqinisekisa ngokugcwele ukuthi uhlelo lwe-chemotherapy oluhlanganisiwe lwe-cetuximab N01 lufana ngokuphepha, ukubekezeleleka, kanye nokuqina komzimba uma kuqhathaniswa ne-chemotherapy ehlanganisiwe ye-cetuximab injection (Erbitux).
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Izinkomba
1.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250207150842162.html
2.Wu CC, Hsu CW, Hsieh MC, nabanye. Ukulandelana Okuhle kanye Nokwelashwa Okuhlelekile Komugqa Wesibili Kweziguli Ezine-RAS Umdlavuza We-Colorectal We-Wild-Type Metastatic: Ukuhlaziywa Kwe-Meta. J Clin Med. 2021 Nov 4;10(21):5166.
Isikhathi sokuthunyelwe: Feb-13-2025