Aqbalaadda Codsiga Ruqsadda Bayoolajiga ee TIVDAK ee Daaweynta Bukaannada qaba Kansarka Afka ee Soo Noqnoqda ama Kaadida Macmalka ah

Maarso 12, 2025, Zai Lab Limited ayaa ku dhawaaqday in Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) uu aqbalay Codsiga Ruqsadda Bayoolajiga (BLA) ee TIVDAK (tisotumab vedotin-tftv) si loogu daaweeyo bukaanada qaba kansarka ilmo-galeenka ee soo noqnoqda ama faafa oo leh cudurro faafa daaweynta nidaamsan ama ka dib.

Soo gudbinta BLA waxaa taageeray natiijooyinka ka soo baxay tijaabada caafimaad ee caalamiga ah ee aan kala sooca lahayn ee innovaTV 301 (NCT04697628) iyo natiijooyinka ka soo baxay tirada yar ee Shiinaha ee daraasaddan.

Wadarta guud ee 502 bukaan ayaa la sameeyay kala soocid (253 ayaa loo qoondeeyay kooxda tisotumab vedotin iyo 249 kooxda kiimoterabiga); kooxuhu waxay isku mid ahaayeen marka loo eego astaamaha dadka iyo cudurrada. Badnaanta guud ee dhexdhexaadka ah waxay si weyn uga dheerayd kooxda tisotumab vedotin marka loo eego kooxda kiimoterabiga (11.5 bilood [95% kalsoonida muddada {CI}, 9.8 ilaa 14.9] marka loo eego 9.5 bilood [95% CI, 7.9 ilaa 10.7]), natiijooyinku waxay muujiyeen khatar dhimasho oo 30% ka hooseysa tisotumab vedotin marka loo eego kiimoterabiga (saamiga khatarta, 0.70; 95% CI, 0.54 ilaa 0.89; laba-dhinac P=0.004). Badbaadada dhexdhexaadka ah ee aan horumarka lahayn waxay ahayd 4.2 bilood (95% CI, 4.0 ilaa 4.4) oo leh tisotumab vedotin iyo 2.9 bilood (95% CI, 2.6 ilaa 3.1) oo leh kiimoterabi (saamiga khatarta, 0.67; 95% CI, 0.54 ilaa 0.82; P-laba-dhinac ah oo laba-dhinac ah oo ah <0.001). Heerka jawaab celinta ujeeddada la xaqiijiyay wuxuu ahaa 17.8% kooxda tisotumab vedotin iyo 5.2% kooxda kiimoterabi (saamiga u-dhiganta, 4.0; 95% CI, 2.1 ilaa 7.6; P-laba-dhinac ah oo ah <0.001). Wadarta 98.4% bukaanada kooxda tisotumab vedotin iyo 99.2% kooxda kiimoterabigu waxay lahaayeen ugu yaraan hal dhacdo oo xun oo dhacday muddada daaweynta (oo lagu qeexay muddada laga bilaabo maalinta 1aad ee qiyaasta 1aad ilaa 30 maalmood ka dib qiyaasta ugu dambeysay); Dhacdooyinka heerka 3aad ama ka weyn waxay dhaceen 52.0% iyo 62.3%, siday u kala horreeyaan. Wadarta 14.8% bukaannada ayaa joojiyay daaweynta tisotumab vedotin sababtoo ah saameyn sun ah.

Ku saabsan TIVDAK (tisotumab vedotin-tftv)

TIVDAK (tisotumab vedotin) waa isku-xidhka daawada antibody-dawada (ADC) oo ka kooban antibody-ga monoclonal-ka aadanaha ee Genmab ee loo jiheeyay qodobka unugyada (TF) iyo tignoolajiyada ADC ee Pfizer kaas oo adeegsada isku xidhe protease-ka-goyn kara kaas oo si isku-dhafan ugu xidha wakiilka microtubule-ka ee khalkhal geliya monomethyl auristatin E (MMAE) antibody-ga. Xogta aan kiliinikada ahayn waxay soo jeedinaysaa in dhaqdhaqaaqa ka-hortagga kansarka ee tisotumab vedotin ay sabab u tahay isku xidhka ADC ee unugyada kansarka ee muujiya TF, oo ay ku xigto gudaha isku-dhafka ADC-TF, iyo sii deynta MMAE iyada oo loo marayo kala-goynta proteolytic. MMAE waxay carqaladeysaa shabakadda microtubule ee unugyada si firfircoon u qaybiya, taasoo horseedaysa xidhitaanka wareegga unugyada iyo dhimashada unugyada apoptotic. In vitro, tisotumab vedotin sidoo kale waxay dhexdhexaadisaa phagocytosis-ka unugyada ku tiirsan antibody-da iyo sunta unugyada ku tiirsan antibody-da.

Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.

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Tixraacyada

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.https://cn.zailaboratory.com/

3.Tisotumab Vedotin oo ah Daaweyn Labaad ama Saddexaad oo loogu talagalay Kansarka Afka ee Soo Noqnoqda | New England Journal of Medicine (nejm.org)