Musi wa3 Zvita, 2024, mushonga mutsva weZepzelca (lurbinectin yejekiseni) wakatenderwa kutengeswa neNational Medical Products Administration (NMPA) yeChina kuburikidza nechirongwa chekuongorora zvinhu zvakakosha. Mushonga uyu unoratidzwa kurapa varwere vakuru vane kenza yemapapu inopararira (SCLC) ine chirwere ichi mushure mekurapwa kana mushure mekurapwa kwechemotherapy yakagadzirwa neplatinum.
Zepzelca inodzivirira kunyorwa kwekenza. Kunyange zvazvo ichidzivirira kunyorwa kwekenza, inodzora nharaunda yemabundu uye inotungamira mukubuda kwemasero emabundu. Mushonga uyu wakatenderwawo neUS Food and Drug Administration (FDA) kuburikidza neAccelerated Approval Program muna 2020. Kwemakore makumi maviri nemanomwe, ndiyo yega kambani itsva yemakemikari yakatenderwa neFDA yekurapa SCLC yakadzoka kubva muna 1997.
Kubvumidzwa kweZepzelca neNMPA kwakavakirwa pamhedzisiro yezvidzidzo zviviri zvekiriniki. Chimwe chazvo chaive chidzidzo chakakosha chakaitwa mhiri kwemakungwa, chidzidzo che open-label, multicenter, uye single-arm study (Phase 2 basket trial) muvarwere vakuru vane SCLC (kusanganisira varwere vane platinum sensitive neplatinum resistant) avo vakaenderera mberi nechirwere mushure mekugamuchira chemotherapy inobva kuplatinum. Muchidzidzo ichi, vakarapwa neZepzelca chete kuburikidza nekuisirwa mushonga mutsinga mavhiki matatu ega ega pachiyero che3.2 mg/m2. Chidzidzo ichi chakaburitswa muThe Lancet Oncology, iyo yakaratidza huwandu hwemhinduro (ORR) hwe35.2%, huwandu hwemhinduro (mDoR) hwemwedzi 5.3, huwandu hwehupenyu husina kufambira mberi (mPFS) hwemwedzi 3.5, uye huwandu hwemwedzi 9.3 kune varwere vese vanorapwa neZepzelca. Imwe ongororo yaive yekudzidza kwekiriniki kweruoko rumwe chete, kwakabatana nekuwedzera kwemushonga weZepzelca uye kuwedzera kwawo kuti aone kuchengetedzeka kwawo, kushivirira, pharmacokinetics (PK), uye kushanda kwawo kwekutanga muvarwere vekuChina vane bundu rakasimba, kusanganisira recurrent SCLC. Chidzidzo ichi chakaratidza ORR ye45.5%, mDoR yemwedzi 4.2, mPFS yemwedzi 5.6 uye mOS yemwedzi 11.0 kune varwere veSCLC vanorapwa neZepzelca kuburikidza ne intravenous infusion mavhiki matatu ega ega padanho re3.2 mg/m2.
Zvidzidzo zviviri zviri pamusoro zvakaratidza kushanda kwakakosha kweZepzelca mukurwisa bundu senzira yechipiri yekurapa SCLC ine ruzivo rwakachengeteka runogoneka. Pamusoro pezvo, chidzidzo chakaitwa muvanhu vekuChina chakaratidza mhedzisiro iri nani yevarwere.
Pamusoro pezvo, Zepzelca iri kuongororwawo mumiedzo yakawanda yekiriniki yepasi rose. Muchidzidzo chePase 1/2, Zepzelca pamwe chete neatezolizumab yakaratidza ORR ye66.67%, mPFS yemwedzi 4.7, uye mOS yemwedzi 14.5 painoshandiswa sekurapa kwechipiri kune varwere vane SCLC yakakura. Mune chimwe chidzidzo chePase 1/2, Zepzelca pamwe chete nepembrolizumab yakaratidza ORR ye46.4%, mPFS yemwedzi 5.3, uye mOS yemwedzi 11.1 sekurapa kwechipiri kune varwere vane SCLC yakadzokera shure. Uyezve, zvidzidzo zvekiriniki zvinosanganisira Zepzelca pamwe chete ne immune checkpoint inhibitor senzira yekutanga yekuchengetedza SCLC, pamwe chete ne chemotherapy yekurapa SCLC yakadzokera shure, uye yekurapa leiomyosarcoma zviri kuenderera mberiwo. Zvidzidzo izvi zvakagadzirirwa kuramba zvichiongorora mashandisirwo ekiriniki uye kugona kwekurapa kwemushonga uyu.
Kusvika pari zvino, Zepzelca yakatenderwa kutengeswa munyika gumi nenomwe nematunhu pasi rose. Luye Pharma yakapihwa kodzero dzekugadzira nekutengesa mushonga uyu munyika yeChina, Hong Kong, neMacao, uye yakagamuchira mvumo yekutengeswa kwemushonga uyu munzvimbo idzi nhatu.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Email：myimmnet@163.com
Mareferensi
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)
Nguva yekutumira: Ndira-14-2025