Ngomhla wama-22 kuMeyi, ngo-2025, i-Allist Pharmaceuticals ibhengeze ukuba iyeza layo elitsha i-Airuikai (Glecirasib Citrate Tablets), i-KRAS-G12C inhibitor, ivunyiwe ngokusemthethweni ukuba iqaliswe kwimarike yi-National Medical Products Administration (NMPA). Le mvume ivumela i-Airuikai ukuba isetyenziswe kunyango lwezigulane zabantu abadala abane-KRAS®®G12C-mutated advanced non-small cell lung cancer (NSCLC) abakhe bafumana ubuncinane umgca omnye wonyango olucwangcisiweyo. Oku kubonisa olunye unyango olutsha lomhlaza wemiphunga oluvunyiweyo kwi-Allist Pharmaceuticals, olubonelela ngokhetho olutsha lonyango lwezigulane ezine-KRASG12C-mutated non-small cell lung cancer (NSCLC) kwaye lunceda ekwakheni ngokutsha imeko-bume yonyango lwale hlobo lomhlaza olunzima ukunyangwa.
Olu vunyiweyo lusekelwe kwiziphumo ezivela kuphando olubalulekileyo lweSigaba sesiBini oluvavanya ukhuseleko, ukunyamezeleka, kunye nokusebenza kakuhle kweGlecirasib monotherapy kwizigulane ezinomhlaza wemiphunga ongengoweeseli ezincinci eziguqukileyo ezine-KRASG12Cmutations eziye zasilela okanye zazinganyamezelani nonyango oluqhelekileyo.
Iziphumo zibonise ukuba iGoleresai iyasebenza kwaye iyanyamezela. Ukusukela nge-28 kaSeptemba 2024, izigulane ze-NSCLC ezili-119 zizonke zibandakanyiwe kuhlalutyo. Izinga lokuphendula eliqinisekisiweyo (cORR), njengoko lihlolwe yiKomiti yoHlolo oluZimeleyo (IRC), yayiyi-49.6% (40.2%-59.0%), kunye nezinga lokulawula isifo (DCR) eliyi-86.3% (78.7%-92.0%). Ubude bexesha eliphakathi lokuphendula (DOR) yayiziinyanga ezili-14.5 (iinyanga ezili-9.6 ukuya kutsho kuqikelelo), ukusinda okuphakathi okungenankqubela phambili (PFS) yayiziinyanga eziyi-8.2 (5.2–11.1), kunye nokusinda okuphakathi (OS) yayiziinyanga ezili-17.5 (iinyanga ezili-13.6 ukuya kutsho kuqikelelo).
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Email：myimmnet@163.com
Ixesha leposi: Meyi-27-2025