Pa Disembala 3, 2024, mankhwala atsopano a Zepzelca (lurbinectin for jakisoni) avomerezedwa kuti agulitsidwe ndi National Medical Products Administration (NMPA) ku China kudzera mu pulogalamu yowunikiranso zinthu zofunika kwambiri. Mankhwalawa akuwonetsedwa kuti agwiritsidwe ntchito pochiza odwala akuluakulu omwe ali ndi khansa ya m'mapapo ya maselo ang'onoang'ono (SCLC) yomwe imafalikira pambuyo pa chemotherapy yokhala ndi platinum kapena itatha.
Zepzelca ndi mankhwala oletsa kulembedwa kwa khansa. Ngakhale kuti amaletsa kulembedwa kwa khansa, amawongolera chilengedwe cha zotupa ndipo amachititsa kuti maselo a chotupa atuluke. Mankhwalawa adavomerezedwanso ndi US Food and Drug Administration (FDA) kudzera mu Accelerated Approval Program yake mu 2020. Kwa zaka 27, wakhala mankhwala okhawo omwe adavomerezedwa ndi FDA pochiza SCLC yobwereranso m'thupi kuyambira 1997.
Kuvomerezedwa kwa Zepzelca ndi NMPA kunachokera ku zotsatira za maphunziro awiri azachipatala. Chimodzi mwa izo chinali kafukufuku wofunika kwambiri wochitidwa kunja kwa dziko, kafukufuku wotseguka, wa multicenter, ndi wa single-hand (mayeso a Gawo 2) mwa odwala akuluakulu omwe ali ndi SCLC (kuphatikizapo odwala omwe ali ndi vuto la platinamu komanso omwe sagonjetsedwa ndi platinamu) omwe adakumana ndi matenda atalandira mankhwala a chemotherapy ochokera ku platinamu. Mu kafukufukuyu, adalandira chithandizo ndi Zepzelca yokha kudzera mu intravenous infusion ya mankhwalawa milungu itatu iliyonse pa mlingo wa 3.2 mg/m2. Kafukufukuyu adasindikizidwa mu The Lancet Oncology, yomwe idawonetsa kuchuluka kwa mayankho (ORR) kwa 35.2%, nthawi yapakati yoyankha (mDoR) ya miyezi 5.3, kupulumuka kwapakati kopanda kupita patsogolo (mPFS) kwa miyezi 3.5, ndi mOS ya miyezi 9.3 kwa odwala onse omwe adalandira chithandizo ndi Zepzelca. Kafukufuku wina anali kafukufuku wachipatala wa mkono umodzi, wogwirizanitsa ndi kukulitsa mlingo wa Zepzelca kuti awone chitetezo chake, kulekerera kwake, pharmacokinetics (PK), ndi mphamvu yake yoyambirira mwa odwala aku China omwe ali ndi zotupa zolimba kwambiri, kuphatikizapo SCLC yobwerezabwereza. Kafukufukuyu adawonetsa ORR ya 45.5%, mDoR ya miyezi 4.2, mPFS ya miyezi 5.6 ndi mOS ya miyezi 11.0 kwa odwala a SCLC omwe amalandira chithandizo cha Zepzelca kudzera mu intravenous infusion milungu itatu iliyonse pa mlingo wa 3.2 mg/m2.
Maphunziro awiri omwe ali pamwambapa adawonetsa mphamvu yayikulu yolimbana ndi chotupa cha Zepzelca ngati chithandizo chachiwiri cha SCLC chokhala ndi chitetezo chodalirika. Kuphatikiza apo, kafukufuku wochitidwa kwa anthu aku China adawonetsa zotsatira zabwino kwa odwala.
Kuphatikiza apo, Zepzelca ikufufuzidwanso m'mayesero ambiri azachipatala apadziko lonse lapansi. Mu kafukufuku wa Gawo 1/2, Zepzelca pamodzi ndi atezolizumab adawonetsa ORR ya 66.67%, mPFS ya miyezi 4.7, ndi mOS ya miyezi 14.5 akagwiritsidwa ntchito ngati chithandizo chachiwiri kwa odwala omwe ali ndi SCLC yayikulu. Mu kafukufuku wina wa Gawo 1/2, Zepzelca pamodzi ndi pembrolizumab adawonetsa ORR ya 46.4%, mPFS ya miyezi 5.3, ndi mOS ya miyezi 11.1 ngati chithandizo chachiwiri kwa odwala omwe ali ndi SCLC yobwereranso. Kuphatikiza apo, maphunziro azachipatala okhudza Zepzelca pamodzi ndi choletsa chitetezo chamthupi ngati chithandizo choyamba chosamalira SCLC, kuphatikiza ndi chemotherapy pochiza SCLC yobwereranso, komanso pochiza leiomyosarcoma akuchitikanso. Maphunziro awa apangidwa kuti apitirize kufufuza momwe mankhwalawa amagwiritsidwira ntchito kuchipatala komanso kuthekera kochiritsira.
Mpaka pano, Zepzelca yavomerezedwa kuti igulitsidwe m'maiko ndi madera 17 padziko lonse lapansi. Luye Pharma yapatsidwa ufulu wopanga ndikugulitsa mankhwalawa ku China, Hong Kong, ndi Macao, ndipo yalandira chilolezo chogulitsa mankhwalawa m'madera atatuwa.
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.
Nambala ya Foni: 4008803716
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Zolemba
1.2024年12月03日药品批准证明文件送达信息 (nmpa.gov.cn)
2.绿叶制药宣布治疗小细胞肺癌创新药赞必佳® (注射用芦比替定) (luye.cn)
Nthawi yotumizira: Januwale-14-2025