Thaum Lub Tsib Hlis 22, 2025, Kelun Bio tau tshaj tawm tias daim ntawv thov rau qhov qhia tshiab ntawm nws cov trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, tseem hu ua SKB264/MK – 2870) (®) tau txais los ntawm Center for Drug Evaluation (CDE) ntawm National Medical Products Administration (NMPA) ntawm Tuam Tshoj. Qhov qhia tshiab no yog rau kev kho mob rau cov neeg laus uas muaj mob qog noj ntshav hauv lub mis (BC) uas tsis tuaj yeem phais tau uas tau kis mus rau lwm qhov chaw lossis kis mus rau lwm qhov chaw. Qhov kev lees txais no yog raws li cov txiaj ntsig zoo ntawm kev sau npe Theem 3 OptiTROP – Breast02 kev tshawb fawb. Daim ntawv thov no yog daim ntawv thov qhia thib plaub rau sac – TMT uas NMPA tau txais.
OptiTROP – Breast02 yog ib qho kev tshawb fawb txog kev kho mob theem 3 uas tau muab faib ua ntau qhov chaw, qhib rau txhua tus neeg mob, thiab ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm kev siv tshuaj sacituzumab tirumotecan monotherapy ntawm koob tshuaj 5 mg/kg txhua ob lub lis piam (Q2W) piv rau kev xaiv tshuaj chemotherapy ntawm cov neeg mob uas muaj mob qog noj ntshav hauv lub mis uas tsis tuaj yeem phais tau lossis kis mus rau lwm qhov (immunohistochemistry [IHC] 0, IHC 1+, lossis IHC 2+/in situ hybridization [ISH]-). Raws li kev tshuaj xyuas ib ntus uas tau teev tseg ua ntej, qhov kawg ntawm kev ua tau zoo ntawm kev tshawb fawb txog kev kho mob theem 3 no tau ua tiav. Piv nrog kev xaiv tshuaj chemotherapy ntawm tus kws kho mob, kev siv tshuaj sac – TMT monotherapy tau qhia txog kev txhim kho tseem ceeb thiab muaj txiaj ntsig zoo hauv qhov kawg ntawm kev ciaj sia tsis muaj kev nce qib (PFS) raws li kev soj ntsuam los ntawm pawg neeg saib xyuas kev ywj pheej tsis pom kev (BIRC), nrog rau kev pheej hmoo ntawm kev nce qib lossis kev tuag tsawg dua. Sac – TMT kuj tau qhia txog qhov sib txawv zoo hauv kev ciaj sia tag nrho (OS).
Thaum lub Tsib Hlis 16, 2024, lub vev xaib official ntawm CDE tau tshaj tawm tias Daim Ntawv Thov yuav raug tshuaj xyuas los ntawm kev tshuaj xyuas thiab kev pom zoo ua ntej. Qhov no yog qhov qhia txog sac-TMT thib plaub uas dhau los ntawm CDE qhov kev tshuaj xyuas thiab kev pom zoo ua ntej, nrog rau peb qhov qhia txog sat-TMT yav dhau los tau pom zoo tom qab kev tshuaj xyuas ua ntej.
Hais txog sac-TMT (佳泰莱®)
Sac-TMT, yog ib yam khoom tseem ceeb ntawm Lub Tuam Txhab, yog ib qho TROP2 ADC tshiab rau tib neeg uas Lub Tuam Txhab muaj cov cai lij choj txog kev txawj ntse, tsom mus rau cov qog nqaij hlav tawv nqaij xws li mob qog nqaij hlav ntsws tsis yog me me (NSCLC), mob qog nqaij hlav BC, mob qog nqaij hlav plab (GC), mob qog nqaij hlav poj niam, thiab lwm yam. Sac-TMT tau tsim los nrog ib qho txuas tshiab los txuas cov khoom thauj, ib qho tshuaj belotecan-derivative topoisomerase I inhibitor nrog rau qhov sib piv ntawm tshuaj rau antibody (DAR) ntawm 7.4. Sac-TMT paub tshwj xeeb txog TROP2 ntawm qhov chaw ntawm cov qog nqaij hlav los ntawm cov tshuaj recombinant anti-TROP2 humanized monoclonal antibodies, uas tom qab ntawd endocytosed los ntawm cov qog nqaij hlav thiab tso tawm KL610023 hauv cov hlwb. KL610023, ua ib qho tshuaj topoisomerase I inhibitor, ua rau DNA puas tsuaj rau cov qog nqaij hlav, uas ua rau lub voj voog ntawm cov qog nqaij hlav nres thiab apoptosis. Tsis tas li ntawd, nws kuj tso tawm KL610023 hauv qhov chaw ib puag ncig ntawm cov qog nqaij hlav. Vim tias KL610023 yog daim nyias nyias permeable, nws tuaj yeem ua rau muaj kev cuam tshuam bystander, lossis hais lwm yam tua cov hlwb qog nqaij hlav ze.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Tsib Hlis-27-2025