NMPA Yavomereza Zanidatamab pa Khansa Yapamwamba ya Biliary Tract ya HER2

Pa Meyi 29, bungwe la National Medical Products Administration (NMPA) linavomereza kugulitsidwa kwa Zanidatamab, komwe kunaperekedwa ndi BeiGene, kuti kuchiritsidwe odwala omwe ali ndi khansa ya m'mimba yosachiritsika kapena yofalikira m'matumbo (BTC) omwe adalandirapo chithandizo chamankhwala amthupi ndipo akuwonetsa HER2 expression yapamwamba (IHC 3+).

Zanidatamab ndi antibody yofufuza ya HER2-target bispecific yomwe imatha kumangirira nthawi imodzi ma epitopes awiri osalumikizana a HER2 receptor, omwe amadziwika kuti biparatopic binding. Kapangidwe kapadera aka komanso kuwonjezeka kwa kumangirira kumabweretsa njira zingapo zogwirira ntchito, kuphatikiza kutsekeka kwa chizindikiro cha HER2 kawiri, kuchotsedwa kwa mapuloteni a HER2 pamwamba pa selo, komanso kuwononga chitetezo cha mthupi zomwe zimapangitsa kuti odwala azichita bwino polimbana ndi chotupa.

Cholandira tyrosine-protein kinase, chomwe chimadziwika kuti Human Epidermal Growth Factor Receptor 2 (HER2) kapena CD340, chili pamwamba pa maselo. Puloteni iyi ndi membala wa banja la Epidermal Growth Factor Receptor (EGFR) ndipo imalembedwa ndi jini la Erythroblastic oncogene B (ERBB2). Jini la ERBB2 ndi lofunika kwambiri pazochitika zabwinobwino monga kugawa maselo, kusiyanitsa, ndi kupulumuka. Kudzera m'njira zosiyanasiyana zolumikizirana, ma HER2 receptors amalimbikitsa kuchulukana kwa maselo ndikuletsa apoptosis (kufa kwa maselo kokonzedwa). Ndikofunikira kuwongolera ma receptor awa kuti aletse kukula kwa maselo kosalamulirika. Khansa zomwe zimakulitsa kapena kukulitsa jini la HER2 zimatchedwa HER2-positive malignancies. Jini iyi imagwira ntchito ngati chizindikiro chofunikira ndipo ndi chandamale chachikulu cha mankhwala.

Komabe, pamene HER2 yakula kapena yachuluka kwambiri, kuchulukana kwa maselo ndi kugawikana kosayang'aniridwa kumathandizira kukula kwa khansa. Kukula kumeneku kapena kuchuluka kwa khansa nthawi zambiri kumapezeka m'mitundu yosiyanasiyana ya khansa ndipo kungakhale ndi tanthauzo lofunikira pa chithandizo cha khansa zomwe nthawi zambiri sizimayembekezeredwa kuti zigwirizane bwino ndi mankhwala oletsa HER2.

Kupezeka kwa HER2-positivity kumapezeka m'mitundu yosiyanasiyana ya khansa monga khansa ya m'mimba, ya biliary tract, ya m'mawere, ya m'mero, ya mazira, ndi ya m'chiberekero. Kuchuluka, kufotokozera, ndi njira zochiritsira za khansa ya HER2-positive payekha zikupezeka mu Table. Posachedwapa, mgwirizano wapezeka ndi khansa ya pancreatic ndi ya biliary tract (BTC). Odwala omwe ali ndi khansa ya HER2-positive nthawi zambiri amakhala ndi chiyembekezo chochepa poyerekeza ndi omwe ali ndi khansa ya HER2-negative, chifukwa khansa imeneyi ndi yoopsa kwambiri. Komabe, njira zatsopano zochiritsira zasonyeza zotsatira zabwino.

Kuvomerezedwa kumeneku kumachokera ku zotsatira za kafukufuku wofunikira wa zachipatala wa HERIZON-BTC-01 (NCT04466891). Uwu unali kafukufuku wapadziko lonse lapansi, wa malo ambiri, wotseguka, wa mkono umodzi, wopangidwa kuti awone momwe zanidatamab imagwirira ntchito komanso chitetezo chake mwa odwala omwe ali ndi BTC yothandizidwa kale, yosachira, HER2-amplified advanced kapena metastatic.

Kafukufukuyu adalembetsa odwala 87 a BTC, kuphatikizapo 62 omwe anali ndi HER2 yochuluka. Zotsatira zake zidawonetsa kuti chithandizo cha Zanidatamab monotherapy chinawonetsa mphamvu yothandiza kuchipatala mwa odwala omwe adachiritsidwa kale ndi HER2-high BTC. Chiwerengero cha mayankho otsimikizika (ORR) chomwe chidawunikidwa pawokha chinali 51.6%, ndi nthawi yapakati yoyankha (mDoR) ya miyezi 14.9, moyo wopanda kupita patsogolo (mPFS) wa miyezi 7.2, ndi moyo wamba (mOS) wa miyezi 18.1.

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.

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