Ngomhlaka-3 Disemba 2024, umuthi omusha i-Zepzelca (i-lurbinectin yomjovo) uvunyelwe ukumakethwa yi-National Medical Products Administration (NMPA) yaseShayina ngohlelo lokubuyekeza okubalulekile. Umuthi ukhonjiswe ekwelapheni iziguli ezindala ezinomdlavuza wamaphaphu wamaseli amancane (i-SCLC) osakazeke kakhulu ngesifo esiqhubekayo ngesikhathi noma ngemva kokwelashwa ngamakhemikhali asekelwe eplatinum.
I-Zepzelca iyisithiyo esikhethekile sokubhalwa kwe-oncogenic. Ngenkathi ivimbela ukubhalwa kwe-oncogenic, ilawula indawo encane yezimila futhi iholela ekuqhekekeni kwamaseli ezimila. Lo muthi wavunyelwa futhi yi-US Food and Drug Administration (FDA) ngohlelo lwayo lwe-Accelerated Approval Program ngo-2020. Sekuyiminyaka engama-27, bekulokhu kuyiyona kuphela inhlangano entsha yamakhemikhali evunyelwe yi-FDA yokwelapha i-SCLC ephinde yasetshenziswa kusukela ngo-1997.
Ukuvunyelwa kwe-Zepzelca yi-NMPA kwakusekelwe emiphumeleni yezifundo ezimbili zezokwelapha. Esinye sazo kwaba ucwaningo olubalulekile olwenziwe phesheya kwezilwandle, ucwaningo oluvulekile, olunezikhungo eziningi, kanye nolwesandla esisodwa (isilingo sebhasikiti seSigaba sesi-2) ezigulini ezindala ezine-SCLC (kufaka phakathi iziguli ezizwela i-platinum kanye neziguli ezingamelani ne-platinum) ezathola ukuqhubekela phambili kwesifo ngemuva kokuthola i-chemotherapy esekelwe ku-platinum. Kulolu cwaningo, belashwa nge-Zepzelca yodwa ngokufaka umuthi ngemithambo njalo emavikini ama-3 ngomthamo ongu-3.2 mg/m2. Ucwaningo lushicilelwe ku-The Lancet Oncology, olubonise izinga lokuphendula eliphelele (ORR) elingu-35.2%, isikhathi esimaphakathi sokuphendula (mDoR) sezinyanga ezingu-5.3, ukusinda okumaphakathi okungenakho ukuqhubekela phambili (mPFS) kwezinyanga ezingu-3.5, kanye ne-mOS yezinyanga ezingu-9.3 kuzo zonke iziguli ezelashwe nge-Zepzelca. Olunye ucwaningo kwakuwucwaningo lwezokwelapha olusebenzisa ingalo eyodwa, oluhlanganisa ukwanda komthamo kanye nokwandiswa kweZepzelca ukuze kuhlolwe ukuphepha kwayo, ukubekezeleleka kwayo, i-pharmacokinetics (PK), kanye nokusebenza kwayo kokuqala ezigulini zaseShayina ezinezimila eziqinile ezithuthukile, okuhlanganisa ne-SCLC ephindaphindayo. Ucwaningo lubonise i-ORR engu-45.5%, i-mDoR yezinyanga ezingu-4.2, i-mPFS yezinyanga ezingu-5.6 kanye ne-mOS yezinyanga ezingu-11.0 ezigulini ze-SCLC ezelashwe nge-Zepzelca ngokuyinika nge-intravenous njalo emavikini ama-3 ngomthamo ongu-3.2 mg/m2.
Izifundo ezimbili ezingenhla zibonise umsebenzi obalulekile wokulwa nomdlavuza we-Zepzelca njengokwelashwa komugqa wesibili kwe-SCLC ngephrofayili yokuphepha elawulekayo. Ngaphezu kwalokho, ucwaningo olwenziwe kubantu baseShayina lubonise imiphumela engcono yeziguli.
Ngaphezu kwalokho, i-Zepzelca iyaphenywa nasezivivinyweni eziningi zezokwelapha zamazwe ngamazwe. Esifundweni seSigaba 1/2, i-Zepzelca ehlanganiswe ne-atezolizumab ibonise i-ORR engu-66.67%, i-mPFS yezinyanga ezingu-4.7, kanye ne-mOS yezinyanga ezingu-14.5 uma isetshenziswa njengokwelashwa komugqa wesibili kweziguli ezine-SCLC enesigaba esikhulu. Kwesinye isifundo seSigaba 1/2, i-Zepzelca ehlanganiswe ne-pembrolizumab ibonise i-ORR engu-46.4%, i-mPFS yezinyanga ezingu-5.3, kanye ne-mOS yezinyanga ezingu-11.1 njengokwelashwa komugqa wesibili kweziguli ezine-SCLC ephinde yasetshenziswa. Ngaphezu kwalokho, izifundo zezokwelapha ezihilela i-Zepzelca ehlanganiswe ne-immune checkpoint inhibitor njengokwelashwa komugqa wokuqala we-SCLC, ehlanganiswe ne-chemotherapy yokwelapha i-SCLC ephinde yasetshenziswa, kanye nokwelashwa kwe-leiomyosarcoma nazo ziyaqhubeka. Lezi zifundo zenzelwe ukuqhubeka nokuhlola ukusetshenziswa kwezokwelapha kanye nekhono lokwelapha lomuthi.
Kuze kube manje, iZepzelca ivunyelwe ukumaketha emazweni nasezifundeni eziyi-17 emhlabeni jikelele. ILuye Pharma inikezwe amalungelo okuthuthukisa nokuthengisa lesi sidakamizwa ezwenikazi laseShayina, iHong Kong, kanye neMacao, futhi ithole imvume yokumaketha lesi sidakamizwa kulezi zifunda ezintathu.
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.
Inombolo yocingo: 4008803716
Email：myimmnet@163.com
Izinkomba
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)
Isikhathi sokuthunyelwe: Jan-14-2025