Ngomhla wesi-3 kweyoMnga ngo-2024, iyeza elitsha iZepzelca (i-lurbinectin yokujova) livunyiwe ukuba lithengiswe yi-National Medical Products Administration (NMPA) yaseTshayina ngenkqubo yokuphonononga izinto ezibalulekileyo. Eli yeza liboniswe kunyango lwezigulane ezindala ezinomhlaza wemiphunga weeseli ezincinci (i-SCLC) eziqhubeka nesifo emva okanye emva kwe-chemotherapy esekelwe kwiplatinum.
I-Zepzelca sisithinteli esikhethiweyo sokubhalwa kwe-oncogenic. Nangona ithintela ukubhalwa kwe-oncogenic, ilawula imeko-bume yeethumba kwaye ikhokelele ekuqhekekeni kweeseli zethumba. Eli yeza likwavunyiwe yi-US Food and Drug Administration (FDA) ngeNkqubo yayo yokuVunywa okuKhawulezayo ngo-2020. Kangangeminyaka engama-27, ibililo lodwa icandelo elitsha leekhemikhali elivunyiweyo yi-FDA kunyango lwe-SCLC ephinde yabuyela kwisimo sayo ukususela ngo-1997.
Ukuvunywa kweZepzelca yi-NMPA kwakusekelwe kwiziphumo zezifundo ezimbini zeklinikhi. Olunye lwazo yayiluphando olubalulekileyo olwenziwe phesheya kolwandle, uphando oluvulekileyo, oluneziko ezininzi, kunye nolwengalo enye (uvavanyo lweSigaba sesi-2 sebhasikithi) kwizigulane ezindala ezine-SCLC (kuquka izigulane ezibuthathaka kwiplatinum kunye nezinganyangekiyo kwiplatinum) eziye zaqhubeka nesifo emva kokufumana i-chemotherapy esekelwe kwiplatinum. Kolu phononongo, banyangwa ngeZepzelca yodwa ngokufaka iyeza ngemithambo rhoqo kwiiveki ezi-3 ngedosi ye-3.2 mg/m2. Olu phononongo lupapashwe kwi-The Lancet Oncology, eyabonisa izinga lokuphendula ngokubanzi (ORR) le-35.2%, ixesha eliphakathi lokuphendula (mDoR) leenyanga ezi-5.3, ukusinda okuphakathi okungenazo iinkqubela phambili (mPFS) leenyanga ezi-3.5, kunye ne-mOS yeenyanga ezi-9.3 kuzo zonke izigulane ezinyangwa ngeZepzelca. Olunye uphando yayiluphando lweklinikhi olusebenzisa ingalo enye, oludibanisa ukunyuka kwedosi kunye nokwandiswa kweZepzelca ukuze kuvavanywe ukhuseleko lwayo, ukunyamezeleka kwayo, i-pharmacokinetics (PK), kunye nokusebenza kwayo kwangaphambili kwizigulana zaseTshayina ezineethumba eziqinileyo eziphucukileyo, kuquka ne-SCLC ephindaphindayo. Olu phononongo lubonise i-ORR engama-45.5%, i-mDoR yeenyanga ezi-4.2, i-mPFS yeenyanga ezi-5.6 kunye ne-mOS yeenyanga ezili-11.0 kwizigulana ze-SCLC ezinyangwa nge-Zepzelca ngokuyinika ngemithambo rhoqo kwiiveki ezi-3 ngedosi eyi-3.2 mg/m2.
Izifundo ezimbini ezingentla zibonise umsebenzi obalulekileyo wokulwa nomhlaza kwiZepzelca njengonyango lwesibini lwe-SCLC oluneprofayili yokhuseleko elawulekayo. Ukongeza, uphando olwenziwe kubemi baseTshayina lubonise iziphumo ezingcono kwizigulana.
Ukongeza, iZepzelca ikwaphandwa kwiimvavanyo ezininzi zeklinikhi zamazwe ngamazwe. Kwisifundo seSigaba 1/2, iZepzelca kunye ne-atezolizumab zibonise i-ORR engama-66.67%, i-mPFS yeenyanga ezi-4.7, kunye ne-mOS yeenyanga ezili-14.5 xa isetyenziswa njengonyango lwesibini kwizigulane ezine-SCLC ebanzi. Kolunye uphando lweSigaba 1/2, iZepzelca edibene ne-pembrolizumab ibonise i-ORR engama-46.4%, i-mPFS yeenyanga ezi-5.3, kunye ne-mOS yeenyanga ezili-11.1 njengonyango lwesibini kwizigulane ezine-SCLC ephinde yabuyela kwi-relaxation. Ngaphezu koko, izifundo zeklinikhi ezibandakanya iZepzelca kunye ne-immune checkpoint inhibitor njengonyango lolondolozo lomgca wokuqala lwe-SCLC, kunye ne-chemotherapy yonyango lwe-SCLC ephinde yabuyela kwi-relaxation, kunye nonyango lwe-leiomyosarcoma nazo ziyaqhubeka. Ezi zifundo zenzelwe ukuqhubeka nokuhlola ukusetyenziswa kweklinikhi kunye nokukwazi konyango lweyeza.
Ukuza kuthi ga ngoku, iZepzelca ivunyiwe ukuba ithengiswe kumazwe ali-17 nakwiindawo zehlabathi. ILuye Pharma inikwe amalungelo okuphuhlisa nokuthengisa eli yeza kwilizwekazi laseTshayina, iHong Kong, neMacao, kwaye ifumene imvume yokuthengisa eli yeza kwezi ndawo zintathu.
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.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Iireferensi
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）获得国家药品监督管理局上市批准 – 新闻动态 – 绿动态 – 雿可叶(luye.cn)
Ixesha leposi: Jan-14-2025