Mankhwala a Tagitanlimab avomerezedwa kuti agwiritsidwe ntchito pochiza odwala omwe ali ndi khansa ya m'mphuno yomwe imabwereranso kapena yofalikira.

Pa Januware 20, National Medical Products Administration (NMPA) yavomereza mankhwala atsopano a monoclonal antibody tagitanlimab.(yomwe kale inali KL-A167) Mankhwala ophatikizana a cisplatin ndi gemcitabine pochiza odwala khansa ya m'mphuno (NPC) omwe amabwereranso kapena kufalikira kwa khansa ya m'mphuno.

Ichi ndi chizindikiro chachiwiri chovomerezedwa cha Tagolizumab. Kale, NMPA yavomereza ku China kuti tagitanlimab monotherapy igwiritsidwe ntchito pochiza odwala omwe ali ndi NPC yobwerezabwereza kapena yofalikira omwe adalephera pambuyo pa chemotherapy ya 2L+ yapitayi.

Kuvomerezedwa kumeneku kumachokera ku kafukufuku wachipatala wa gawo lachitatu wochitidwa mwachisawawa, wopangidwa ndi maso awiri, wolamulidwa ndi placebo, wokhala ndi malo ambiri, womwe umawunika zotsatira za tagitanlimab pamodzi ndi cisplatin ndi gemcitabine motsutsana ndi placebo pamodzi ndi cisplatin ndi gemcitabine pochiza NPC yobwerezabwereza kapena yofalikira, yomwe idatsogozedwa ndi Pulofesa Shi Yuankai wa Cancer Hospital Chinese Academy of Medical Sciences monga wofufuza wamkulu.

Malinga ndi zotsatira za kafukufukuyu, tagitanlimab yogwiritsidwa ntchito limodzi ndi cisplatin ndi gemcitabine pochiza matenda oyamba a NPC yobwerezabwereza kapena yofalikira ikhoza kukhala ndi moyo wabwino wopanda progression-free survival (PFS), higher objective response rate (ORR) komanso extended duration of response (DoR) poyerekeza ndi chemotherapy, komwe odwala onse angapindule mosasamala kanthu za PD-L1 expression. PFS yapakati ya tagitanlimab yophatikizidwa ndi chemotherapy siifikiridwa poyerekeza ndi miyezi 7.9 ya placebo yophatikizidwa ndi chemotherapy, ndipo chiopsezo cha kupita patsogolo kwa matenda ndi imfa chimachepetsedwa ndi 53%; ORR ndi 81.7% vs 74.5%; DoR yapakati ndi miyezi 11.7 vs 5.8, yomwe yawirikiza kawiri poyerekeza ndi placebo arm; pakadali pano apakati pa moyo wonse (OS) sanakule, komabe njira yopindulitsa ya OS ya tagitanlimab yophatikizidwa ndi chemotherapy yawonedwa kale, ndipo chiopsezo chake cha imfa chimachepetsedwa ndi 38%. Tagitanlimab idawonetsanso chitetezo chodalirika.

Zokhudza NPC

Deta ya GLOBOCAN ya 2022 inasonyeza kuti panali milandu yatsopano yoposa 120,000 ya khansa ya m'mphuno padziko lonse lapansi, milandu yatsopano 51,000 ya khansa ya m'mphuno ndi imfa 28,400 ku China. Malinga ndi malangizo a CSCO a 2021, njira yothandizira khansa ya m'mphuno ya 1L yomwe singathe kuchiritsidwa m'deralo imachokera ku mankhwala ophatikizana okhala ndi platinum, ndipo chithandizo cha 2L chimachokera ku monotherapy. Chiwerengero cha odwala omwe ali ndi khansa ya m'mphuno ya ...

About Tagitanlima

Tagitanlima, yopangidwa ndi Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (Chengdu, China), ndi antibody ya IgG1κ monoclonal yopangidwa ndi munthu yomwe imayang'ana PD-L1 yomwe imaletsa kuyanjana kwa PD-L1 ndi PD-1.

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.

Nambala ya Foni: 4008803716

Imelo：myimmnet@163.com

Zolemba

1.国家药品监督管理局 (nmpa.gov.cn)

2.Kampani ya Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.