Pa June 30, tsamba lovomerezeka la National Medical Products Administration (NMPA) linalengeza kuti Anlotinib, mankhwala atsopano a Class 1 omwe adapangidwa ndi Chia Tai Tianqing, avomerezedwa ndi chizindikiro chatsopano ku China: mankhwala ophatikizana ndi chemotherapy pochiza odwala omwe ali ndi sarcoma yofewa yomwe singathe kuchiritsidwa m'deralo kapena yofalikira m'thupi (STS) omwe sanalandire chithandizo chamankhwala. Ichi ndi chizindikiro chachisanu ndi chinayi chovomerezeka cha Anlotinib ku China ndipo chikusonyeza kuvomerezedwa ndi boma kwa mankhwala oyamba padziko lonse lapansi ophatikizana a chemotherapy pochiza matenda oyamba a STS.
Anlotinib (AL3818, Anlotinib Hydrochloride) ndi mankhwala atsopano a tyrosine kinase inhibitor (TKI) omwe ali ndi mamolekyulu ang'onoang'ono omwe amaletsa bwino ma kinase monga VEGFR, PDGFR, FGFR, ndi c-Kit, omwe ali ndi mphamvu zotsutsana ndi chotupa komanso zoletsa kukula kwa chotupa.
Sarcoma ya minofu yofewa (STS) ndi mtundu wa chotupa choipa chochokera ku minofu yopanda epithelial extraskeletal, ndipo chiŵerengero cha anthu pachaka chimakhala pafupifupi 2.91 pa anthu 100,000 ku China, zomwe zikusonyeza kuti chikukwera chaka ndi chaka [1-3]. STS imaphatikizapo mitundu 19 ya histological ndi mitundu yoposa 50 yosiyana ya matenda. Kwa zaka zambiri, mankhwala ochizira matenda a anthracycline akhala ngati maziko a chithandizo choyamba cha STS.
Pa Msonkhano Wapachaka wa 2025 wa American Society of Clinical Oncology (ASCO), kampaniyo idapereka zotsatira zabwino kuchokera ku kafukufuku wachipatala wa Gawo III wa Anlotinib Hydrochloride Capsules pamodzi ndi chemotherapy pochiza matenda a STS osachiritsika kapena ofalikira.
Njira: Madokotala oyenerera anali asanalandire chithandizo, atatsimikiziridwa kuti ali ndi matenda, osachira m'deralo kapena STS yofalikira. Madokotala adapatsidwa mankhwala mwachisawawa mu chiŵerengero cha 1:1 kuti alandire ALTN (12mg) pakamwa kamodzi patsiku (kupuma kwa milungu iwiri pa sabata imodzi) kuphatikiza EH (90 mg/m2) kudzera m'mitsempha kamodzi pa milungu itatu iliyonse mpaka maulendo 6, kutsatiridwa ndi ALTN yosamalira (12mg) pakamwa kamodzi patsiku (kupuma kwa milungu iwiri pa sabata imodzi) kapena PBO (0mg) pakamwa kamodzi patsiku (kupuma kwa milungu iwiri pa sabata imodzi) kuphatikiza EH (90 mg/m2) kudzera m'mitsempha kamodzi pa milungu itatu iliyonse mpaka maulendo 6, kutsatiridwa ndi PBO yosamalira (0mg) pakamwa kamodzi patsiku (kupuma kwa milungu iwiri pa sabata imodzi). Mapeto oyamba anali PFS yowunikidwa ndi komiti yowunikira yodziyimira payokha malinga ndi RECIST 1.1. Mapeto achiwiri anali OS, Objective Response Rate (ORR), Disease control rate (DCR) ndi chitetezo.
Zotsatira: Ma pts 272 onse adachitika mwachisawawa: 135 ku ALTN + EH arm, 137 ku PBO + EH arm. Pofika pa 15 February, 2024, pambuyo pa kutsatiridwa kwapakati kwa miyezi 7.16, ALTN + EH arm idasintha kwambiri PFS (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; yapakati 8.57 vs 3.02 mo), ndi ORR (17.8% vs 2.90%; P < 0.001), DCR (79.3% vs 54.7%; P < 0.001) motsutsana ndi PBO + EH arm. Median OS sinafike m'manja onse awiri (HR = 0.78 [95% CI: 0.49-1.25]). Ubwino wa ALTN + EH unawonedwa m'magulu ambiri omwe adayesedwa, kuphatikizapo leiomyosarcoma, synovial sarcoma ndi mitundu ina ya matenda. Kuchuluka kwa zochitika zoyipa za Giredi ≥3 (AEs) (69.6% vs 59.1%), AE zomwe zidapangitsa kuti chithandizo chisiye (3.7% vs 4.4%), AEs zakupha (3.7% vs 3.6%) zinali zofanana pakati pa manja awiri.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Nthawi yotumizira: Julayi-01-2025