A ranar 30 ga Yuni, shafin yanar gizo na Hukumar Kayayyakin Lafiya ta Kasa (NMPA) ya sanar da cewa Anlotinib, wani sabon magani na Aji 1 da Chia Tai Tianqing ta ƙirƙiro, ya sami amincewar wani sabon magani a China: maganin haɗin gwiwa tare da maganin chemotherapy don maganin farko ga marasa lafiya da ke fama da sarcoma mai laushi na jiki (STS) wanda ba a iya cirewa ba a cikin gida ko kuma waɗanda ba a taɓa samun maganin tsari ba a baya. Wannan ya nuna alama ta tara da aka amince da ita ga Anlotinib a China kuma yana nuna amincewar hukuma ta hanyar maganin haɗin gwiwa na farko na chemotherapy a duniya don maganin farko na STS mai ci gaba ko wanda ya ci gaba.
Anlotinib (AL3818, Anlotinib Hydrochloride) wani sabon maganin hana ƙwayoyin cuta masu yawa (small-molecule multi-target tyrosine kinase inhibitor) ne wanda ke hana kinases kamar VEGFR, PDGFR, FGFR, da c-Kit yadda ya kamata, yana haifar da tasirin hana ci gaban ƙari da hana ci gaban ƙari.
Sarcoma na nama mai laushi (STS) wani nau'in ciwon daji ne mai tsanani wanda ya samo asali daga kyallen da ba na epithelial ba, tare da adadin kamuwa da cutar a kowace shekara kusan 2.91 a cikin mutane 100,000 a China, wanda ke nuna karuwar ci gaba kowace shekara [1-3]. STS ya ƙunshi nau'ikan histological guda 19 da kuma nau'ikan cututtuka daban-daban sama da 50. Tsawon shekaru da dama, chemotherapy da aka yi da anthracycline ya yi aiki a matsayin ginshiƙin maganin farko ga STS.
A taron shekara-shekara na American Society of Clinical Oncology (ASCO) na shekarar 2025, kamfanin ya gabatar da sakamakon nasara daga nazarin asibiti na Mataki na III na Anlotinib Hydrochloride Capsules tare da haɗin gwiwa da chemotherapy don maganin STS na farko wanda ba za a iya cirewa ba ko kuma wanda ya kamu da cutar.
Hanyoyi: An riga an yi wa waɗanda suka cancanta magani, waɗanda aka tabbatar da cewa suna da cutar, waɗanda ba a iya cire su daga jiki ba, waɗanda suka kamu da cutar, ko kuma waɗanda suka kamu da cutar a yankinsu. An yi wa waɗanda suka kamu da cutar gwaji a cikin rabo na 1:1 don a ba su ALTN (12mg) ta baki sau ɗaya a rana (mako 2 a rana/mako 1 a hutu) da EH (90 mg/m2) ta jijiya sau ɗaya a kowace mako 3 har zuwa zagaye 6, sannan a yi musu magani ALTN (12mg) ta baki sau ɗaya a rana (mako 2 a rana/mako 1 a hutu) ko PBO (0mg) ta baki sau ɗaya a rana (mako 2 a rana/mako 1 a hutu) da EH (90 mg/m2) ta jijiya sau ɗaya a kowace mako 3 har zuwa zagaye 6, sannan a yi musu magani PBO (0mg) ta baki sau ɗaya a kowace rana (mako 2 a rana/mako 1 a hutu). Babban ƙarshen gwajin an tantance shi ta kwamitin bita mai zaman kansa mai zaman kansa bisa ga RECIST 1.1. Babban ƙarshen gwajin ya haɗa da OS, Matsakaicin Amsawar Manufofi (ORR), Matsakaicin Kula da Cututtuka (DCR) da aminci.
Sakamako: Jimillar maki 272 an yi su ne bisa ka'ida: 135 zuwa hannun ALTN + EH, 137 zuwa hannun PBO + EH. Tun daga ranar 15 ga Fabrairu, 2024, bayan an yi bin diddigin matsakaicin watanni 7.16, hannun ALTN + EH ya inganta PFS sosai (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; matsakaicin watanni 8.57 vs 3.02), da ORR (17.8% vs 2.90%; P < 0.001), DCR (79.3% vs 54.7%; P < 0.001) idan aka kwatanta da hannun PBO + EH. Ba a kai matsakaicin OS a kowane hannu ba (HR = 0.78 [95% CI: 0.49-1.25]). An lura da fa'idar hannun ALTN + EH a yawancin ƙananan ƙungiyoyi da aka gwada, ciki har da leiomyosarcoma, synovial sarcoma da sauran nau'ikan cututtuka. Yawan aukuwar abubuwan da suka faru na rashin lafiya na Grade ≥3 (AEs) (69.6% vs 59.1%), AEs waɗanda suka haifar da dakatar da magani (3.7% vs 4.4%), AEs masu mutuwa (3.7% vs 3.6%) sun kasance iri ɗaya tsakanin hannuwa biyu.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Lokacin Saƙo: Yuli-01-2025