Musi wa29 Nyamavhuvhu, mushonga weHERNEXEOS® (mapiritsi ezongertinib) waBoehringer Ingelheim wakatenderwa semushonga mumwe chete neNational Medical Products Administration (NMPA) yekurapa varwere vakuru vane kenza yemapapu isingabvisike, yakakwira munharaunda kana kuti inopararira isina masero madiki (NSCLC) vane mamota ane shanduko dzinoita kuti HER2 (ERBB2) ishande uye vakamborapwa kanenge kamwe chete kare.
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
Nhamba yeWeChat: 17801183037
Email：myimmnet@163.com
Mvumo iyi yakapihwa zvichibva padata kubva mukuyedzwa kwePhase Ib Beamion-LUNG 1 (NCT04886804): Muedzo wekuwedzera huwandu hwemushonga wePhase I, une kusimbiswa kwemushonga uye kuwedzerwa, wezongertinib semushonga mumwe chete muvanhu vane tumors dzakasimba dzisingabvisike kana dzakapararira dzine HER2 alterations. Chidzidzo ichi chine zvikamu zviviri. Chikamu chekutanga chakavhurika kune vakuru vane mhando dzakasiyana dzekenza yepamusoro ine HER2 alterations dzinosanganisira mutations, amplifications, over-expression uye fusions avo kurapwa kwavo kwakamboitwa kusina kubudirira. Chikamu chechipiri chakavhurika kune vanhu vane HER2-mutant non-small cell lung cancer.
Muboka rekutanga, varwere vanosvika makumi manomwe nevashanu vakagamuchira zongertinib pachiyero che120 mg. Pakachekwa data (Mbudzi 29, 2024), 71% yevarwere ava (95% confidence interval [CI], 60 kusvika 80; P<0.001 zvichienzaniswa ne≤30% benchmark) vaive nemhinduro yakasimbiswa; nguva yepakati yemhinduro yaive mwedzi 14.1 (95% CI, 6.9 kusvika isingaongororwe), uye avhareji yekurarama pasina kufambira mberi yaive mwedzi 12.4 (95% CI, 8.2 kusvika isingaongororwe). Zviitiko zvakaipa zvine chekuita nemishonga zveGiredhi 3 kana kupfuura zvakaitika muvarwere gumi nevatatu (17%). Muboka rekutanga (varwere 31), 48% yevarwere (95% CI, 32 kusvika 65) vaive nemhinduro yakasimbiswa. Zviitiko zvakaipa zvine chekuita nemishonga zveGiredhi 3 kana kupfuura zvakaitika mumurwere mumwe chete (3%). Muboka rechitatu (varwere makumi maviri), 30% yevarwere (95% CI, 15 kusvika 52) vakaratidza mhinduro yakasimbiswa. Zviitiko zvakaipa zvine chekuita nemishonga zveGiredhi rechitatu kana kupfuura zvakaitika muvarwere vashanu (25%). Mumapoka ese matatu, hapana nyaya dzechirwere chemapapu chine chekuita nemishonga chakaitika.
"Zvinokurudzira kuona NMPA ichiramba ichiziva kugona kwezongertinib. Kusarudzwa kwenzira yekutanga yekurapa kwezongertinib muChina kunoratidza kudiwa kukuru kwevarwere ava. Danho rinotevera rakakosha rekuita kuti kurapwa uku kuwanikwe kune varwere vakawanda vanoda rubatsiro," akadaro Shashank Deshpande, Sachigaro weBhodhi reManaging Directors kuBoehringer Ingelheim.
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
Nhamba yeWeChat: 17801183037
Email：myimmnet@163.com
Nguva yekutumira: Gunyana-02-2025