Codsiga Cusub ee Dawada ee Kansarka Naasaha ee Saddex-geesoodka Metastatic

Siideynta Xorta ah ee HAYS | eTurboNews | eTN
Written by Linda Hohnholz

Everest Medicines Limited, oo ah shirkad biopharmaceutical ah oo diiradda saarey horumarinta iyo ka ganacsiga dawooyinka isbeddelka ah ee Aasiya, ayaa maanta ku dhawaaqday in Maamulka Cuntada iyo Dawooyinka ee Taiwan (TFDA) ay aqbashay soo gudbinta Codsiga Dawooyinka Cusub (NDA) ee sacituzumab govitecan (SG) ee bukaanka qaangaarka ah. leh TNBC maxalli ah oo horumarsan ama dheef-shiid kiimikaad ah kuwaas oo helay laba ama in ka badan daawayn nidaameed oo hore, ugu yaraan mid ka mid ah cudurka metastatic. Daawaynta waxaa la siiyay Dib-u-eegga Mudnaanta Cudurrada Naadirka ah ee Carruurta iyo Naadirka daran ee ay bixisay Taiwan FDA bishii Luulyo 2021.

Sida hoos timaada magaca ganacsiga Trodelvy®, US FDA waxay hore u siisay ogolaansho degdeg ah SG bishii Abriil 2020 ka dibna waxay balaadhisay tilmaanteeda iyada oo si buuxda loo oggolaaday Abriil 2021 bukaannada qaangaarka ah ee aan la silcin karin gudaha horumarsan ama mTNBC kuwaas oo helay laba ama in ka badan oo daaweyn nidaameed ka hor, at ugu yaraan mid iyaga ka mid ah oo loogu talagalay cudurka metastatic. Bishii Maajo 2021, Everest waxay ku dhawaaqday in Maamulka Alaabooyinka Caafimaadka Qaranka ee Shiinaha aqbaleen Codsiga Shatiga Bayolojiga iyada oo mudnaanta koowaad siinaysa SG bukaannada qaangaarka ah ee aan la hagaajin karin gudaha gudaha ama TNBC-da ee helay laba ama in ka badan daawaynta nidaamsan, ugu yaraan mid ka mid ah oo loogu talagalay metastatic cudur.

Bishii Noofambar 2021, Everest waxay ku dhawaaqday natiijooyinka ugu sarreeya ee wejigeeda 2b EVER-132-001 ee SG, kaas oo la kulmay barta ugu dambaysa ee 38.8% heerka jawaabta guud (ORR). Daraasaddan waxaa ku jiray 80 qof oo Shiinaha ku nool, natiijaduna waxay la jaan qaadaysay kuwii ka soo baxay daraasadda caalamiga ah ee 3 ASCENT, sidaas darteed waxay muujinaysaa waxtarka la midka ah ee dadka Shiinaha. 

TNBC waa nooca kansarka naasaha ee ugu qallafsan wuxuuna xisaabiyaa qiyaastii 15% dhammaan kansarka naasaha. Da'da dhexe ee ogaanshaha kansarka naasaha waxay u egtahay inay ka da' yar tahay Aasiyaanka wadamada galbeedka, iyo boqolkiiba nooca unugyada TNBC ayaa sii kordhayay 10kii sano ee la soo dhaafay. Unugyada TNBC ma laha estrogen iyo progesterone reseptors waxayna leeyihiin xaddidan oo ah factor factor koritaanka epidermal aadanaha 2 (HER2). Sababtoo ah dabeecadda TNBC, ikhtiyaarrada daawaynta waxtarka leh ayaa aad u xaddidan marka la barbar dhigo noocyada kale ee kansarka naasaha. TNBC waxay leedahay fursad sare oo soo noqnoqosha ah iyo metastases marka loo eego noocyada kale ee kansarka naasaha. Celceliska wakhtiga soo noqnoqoshada metastatic ee TNBC waa qiyaastii 2.6 sano marka la barbar dhigo 5 sano ee kansarrada kale ee naasaha, iyo heerka badbaadada shanta sano ee la soo dhaafay aad ayuu u hooseeyaa. Dumarka qaba TNBC metastatic, heerka badbaadada shanta sano waa 12%, marka la barbar dhigo 28% kuwa qaba noocyada kale ee kansarka naasaha ee metastatic.

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Linda Hohnholz

Tafatiraha guud ee eTurboNews ku salaysan eTN HQ.

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