Sacituzumab Tirumotecan (sac-TMT) Yavomerezedwa Kuti Igulitsidwe mu Chizindikiro Chachiwiri ndi NMPA ya EGFRm NSCLC

Pa Marichi 10, 2025, Sichuan Kelun-Biotech adalengeza kuti kampani ya trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, yomwe kale inali SKB264/MK-2870) yavomerezedwa kuti igulitsidwe ndi National Medical Products Administration (NMPA) ngati chizindikiro chachiwiri chomwe ndi chithandizo cha odwala akuluakulu omwe ali ndi epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) pambuyo pa kupita patsogolo kwa chithandizo cha EGFR-tyrosine kinase inhibitor (TKI) ndi platinum-based chemotherapy. Ichi ndi mankhwala oyamba a TROP2 ADC omwe avomerezedwa kuti agulitsidwe khansa ya m'mapapo padziko lonse lapansi. Poyerekeza ndi muyezo wa chisamaliro chamakono, sac-TMT imawonjezera kwambiri phindu lonse la odwala awa.

Kuvomerezedwa kumeneku kumachokera ku kafukufuku wofufuza wa malo ambiri, wosasankhidwa, wowongoleredwa, komanso wofunikira (OptiTROP-Lung03) womwe umawunika momwe mankhwala a sac-TMT monotherapy a 5mg/kg amagwirira ntchito sabata iliyonse (Q2W) monga jakisoni wolowetsedwa m'mitsempha motsutsana ndi docetaxel pochiza odwala omwe ali ndi EGFR-mutant NSCLC yotsogola kapena yofalikira kwambiri omwe alephera atalandira chithandizo cha EGFR-TKI ndi platinum-based chemotherapy (yogwiritsidwa ntchito motsatizana kapena mophatikizana). Monga momwe zasonyezedwera mu kusanthula kwakanthawi kofotokozedwa kale, sac-TMT monotherapy yawonetsa kusintha kwakukulu komanso kofunikira kuchipatala mu objective response rate (ORR), progression-free survival (PFS) ndi oversuffering (OS) poyerekeza ndi docetaxel.

About sac-TMT

Sac-TMT ndi kampani yatsopano ya TROP2 ADC ya anthu yomwe Kampaniyo ili ndi ufulu waumwini wazinthu zamaganizo, ikuyang'ana kwambiri zotupa zolimba monga NSCLC, khansa ya m'mawere (BC), khansa ya m'mimba (GC), zotupa za amayi, pakati pa zina. Sac-TMT imapangidwa ndi cholumikizira chatsopano kuti igwirizane ndi katundu wolipira, choletsa cha topoisomerase I chochokera ku belotecan chokhala ndi chiŵerengero cha mankhwala-ku-antibody (DAR) cha 7.4. Sac-TMT imazindikira makamaka TROP2 pamwamba pa maselo a chotupa ndi ma antibodies a monoclonal opangidwa ndi recombinant anti-TROP2, omwe kenako amachotsedwa ndi maselo a chotupa ndikutulutsa KL610023 mkati mwa maselo. KL610023, monga choletsa topoisomerase I, imayambitsa kuwonongeka kwa DNA kwa maselo a chotupa, zomwe zimapangitsa kuti maselo asamayende bwino komanso kuti apoptosis ichitike. Kuphatikiza apo, imatulutsanso KL610023 m'malo ozungulira chotupa. Popeza KL610023 imatha kulowa mu nembanemba, imatha kuyambitsa zotsatira zowoneka ngati munthu akuyang'ana, kapena mwa kuyankhula kwina kupha maselo otupa omwe ali pafupi.

M'mbuyomu, NMPA idavomereza kutsatsa kwa sac-TMT ku China kwa odwala akuluakulu omwe ali ndi khansa ya m'mawere yosachiritsika kapena yofalikira m'malo omwe ali ndi khansa ya m'mawere (TNBC) yomwe singathe kuchiritsidwa omwe adalandirapo mankhwala osachepera awiri am'mbuyomu (osachepera amodzi mwa iwo omwe ali ndi khansa ya m'mawere yomwe ili ...

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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Nthawi yotumizira: Marichi-20-2025