NMPA Ivomereza Trastuzumab Rezetecan (SHR-A1811) ya HER2-Mutated NSCLC

Pa Meyi 29, bungwe la National Medical Products Administration (NMPA) linavomereza mankhwala otchedwa HER2-target antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) kuti agulitsidwe. Amagwiritsidwa ntchito ngati mankhwala amodzi okha ochizira odwala akuluakulu omwe ali ndi khansa ya m'mapapo yosasinthika (NSCLC) yomwe ingayambitse matenda a HER2 (ERBB2) ndipo adalandira chithandizo chimodzi cham'mbuyomu. Ichi ndi chizindikiro choyamba cha ADC chopangidwa ku China chovomerezedwa kwa odwala omwe ali ndi HER2-mutated NSCLC, chomwe chimapereka njira yatsopano yothandizira odwalawa.

Chivomerezochi chachokera pa kafukufuku wofunika kwambiri wa HORIZON-Lung, wotsogozedwa ndi Pulofesa Lu Shun wochokera ku Shanghai Chest Hospital.

Kafukufuku wa HORIZON-Lung ndi kafukufuku wamankhwala wa Gawo I/II wochitidwa m'malo osiyanasiyana, wotsogozedwa ndi gulu la Pulofesa Lu Shun ku Shanghai Chest Hospital. Gawo la Gawo I linkafuna kudziwa mlingo wovomerezeka kwambiri (MTD) wa trastuzumab rezetecan ndikuwunika momwe imagwirira ntchito komanso chitetezo chake mwa odwala omwe ali ndi HER2-mutated NSCLC. Kapangidwe ka kafukufukuyu kanaphatikizapo magawo onse awiri a kuchuluka kwa mlingo ndi kukula kwa mlingo. Mu gawo la Gawo I, trastuzumab rezetecan inawonetsa mphamvu yoyambirira yolimbana ndi chotupa komanso mbiri yabwino yotetezeka. Kafukufuku wa Gawo II adapangidwa kuti apititse patsogolo kuwunika momwe trastuzumab rezetecan imagwirira ntchito komanso chitetezo chake mwa odwala omwe ali ndi HER2-mutated NSCLC.

Odwala onse 94 adalembetsa mu kafukufukuyu. Zotsatira zake zidawonetsa kuti chiŵerengero cha mayankho olondola (ORR), monga momwe adawunikira ndi Independent Review Committee (IRC), chinali 74.5%, ndi chiŵerengero chowongolera matenda (DCR) cha 98.9%. Nthawi yapakati yoyankha (DoR) inali miyezi 9.8. Kusanthula kwa magulu ang'onoang'ono kunawonetsa kuti kugwira ntchito kwa trastuzumab rezetecan kunali kofanana m'magulu ang'onoang'ono osiyanasiyana a odwala, mosasamala kanthu za chithandizo cha anti-HER2 tyrosine kinase inhibitor (TKI) kapena kukhalapo kwa metastases yoyambira muubongo.

Kupulumuka kosapitirira muyeso kwa IRC (PFS) kunawonetsa PFS yapakati ya miyezi 11.5, ndi chiŵerengero cha PFS cha miyezi 12 cha 48.6%. PFS yofufuzidwa (INV) inali miyezi 12.5, ndi chiŵerengero cha PFS cha miyezi 12 cha 51.4%.

Deta yonse yopulumuka (OS) sinakwaniritsidwebe, pomwe OS yapakati sinafikebe ndipo chiŵerengero cha OS cha miyezi 12 cha 88.2%.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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