Limertinib Yawana Mvumo muChina yeEGFR T790M+ NSCLC

Musi wa16 Ndira, 2025, National Medical Products Administration (NMPA) yeChina yakabvumidza New Drug Application (NDA) ye limertinib yekurapa varwere vakuru vane EGFR T790M-mutated non-small cell lung cancer (NSCLC) yakakwira kana kuti yakapararira munharaunda.

Nezve Limertinib

Limertinib mushonga wechizvarwa chechitatu weEGFR TKI unopihwa nemuromo, une kodzero dzekuva muridzi, wakatenderwa neNMPA yeChina yekurapa varwere vakuru vane kenza yemapapu yeEGFR T790M yakachinja masero madiki (NSCLC). NDA yechipiri iri pasi peongororo yeNMPA yekurapa varwere vakuru vane kenza yemapapu yeEGFR T790M yakachinja masero madiki (NSCLC) kana kuti yakachinja masero eEGFR exon 19 kana exon 21 L858R.

Mushonga uyu wakabudirira mukuyedzwa kwekiriniki kwechikamu chechitatu chekurapa kwakaitwa munzvimbo dzakawanda, kwakasarudzwa, kusina kupofumadzwa kaviri, uye kwakadzorwa, uchienzanisa kushanda kwawo uye kuchengetedzeka kwegefitinib mukurapa varwere vane NSCLC yepamusoro kana kuti ine EGFR mutations munharaunda. Kana mhedzisiro yekutanga yawanikwa, mhedzisiro icharatidzwa pamisangano yedzidzo iri kuuya kana kuburitswa mumajenari edzidzo.

Sarudzo yemutemo yakatsigirwa nedata kubva muongororo yechikamu chechipiri chebvunzo (NCT03502850). Iyi iongororo yechikamu chechipiri chebvunzo imwe chete, yakavhurika, yakaitwa muzvipatara makumi matanhatu nembiri muPeople's Republic of China. Varwere vane NSCLC yepamusoro kana kuti yakapararira munharaunda vane shanduko dzeEGFR T790M dzakasimbiswa munyama yebundu kana plasma yeropa vakaenderera mberi mushure mekutanga kana kwechipiri EGFR tyrosine kinase inhibitors kana vane shanduko dzekutanga dzeEGFR T790M vakanyoreswa.

Kubva musi wa16 Chikunguru 2019, kusvika musi wa10 Kurume 2021, varwere vanosvika 301 vakanyoreswa uye vakatanga kurapwa ne limertinib. Varwere vese vakapinda muongororo yakazara uye seti yekuchengetedza. Pakazosvika zuva rekupedzisira redata musi wa9 Gunyana 2021, 76 (25.2%) vakaramba vari pakurapwa. Nguva yekutevera yaive mwedzi 10.4. Zvichienderana neongororo yakazara, komiti yakazvimirira yekuongorora ORR yaive 68.8% uye chiyero chekutonga chirwere chaive 92.4%. PFS yaive mwedzi 11.0, DoR yaive mwedzi 11.1, uye OS yepakati haina kusvikwa. Mhinduro dzechinangwa dzakawanikwa mumapoka ese akatarwa. Kune varwere 99 (32.9%) vane chirwere chepakati petsinga (CNS), ORR yaive 64.6%, avhareji yePFS yaive mwedzi 9.7 (95% CI: 5.9–11.6), uye avhareji yeDoR yaive mwedzi 9.6. Kune varwere 41 vaive nechirwere cheCNS chinoongororwa, CNS-ORR yakasimbiswa yaive 56.1% uye avhareji yeCNS-PFS yaive mwedzi 10.6.

Mukuchengetedzwa kwakachengeteka, varwere 289 (96.0%) vakasangana nedambudziko rimwe chete rine chekuita nekurapwa (TRAE), iro rinonyanya kuitika riri manyoka (81.7%), anemia (32.6%), mapundu (29.9%), uye anorexia (28.2%). Mapundu eTRAE eGiredhi ≥3 akaitika muvarwere 104 (34.6%), ayo akanyanya kuitika anosanganisira manyoka (13.0%), hypokalemia (4.3%), anemia (4.0%), uye mapundu (3.3%). Mapundu eTRAE anokonzera kukanganisika kwedosi uye kurega kutora dosi akaitika mu24.6% ne2% yevarwere, zvichiteerana. Hapana TRAE yakakonzera rufu yakaitika.

Mhedziso

Limertinib (ASK120067) yakawanikwa iine simba rinovimbisa uye ine humbowo hwekuchengetedza hunogamuchirika pakurapa varwere vane EGFR T790M-mutated NSCLC yepamusoro kana kuti yakapararira munharaunda.

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.国家药品监督管理局 (nmpa.gov.cn)

2.Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) (ask-pharm.com)

3.Innovation naASK Pharm Vakabatana Kuzivisa Kubvumidzwa kweNMPA kweLimertinib, mushonga wechizvarwa chechitatu weEGFR TKI wekurapa Cancer yeMapupa (prnewswire.com)

4.https://www.jto.org/article/S1556-0864(22)00267-2/fulltext