Roche PD-1 inhibitor therapy isku darka kansarka beerka waxaa u aqoonsaday FDA inay tahay daaweyn horumarineed

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Kooxda Swiss Roche Group ayaa shalay ku dhawaaqday in TECENTRIQ® (atezolizumab) Marka lagu daro Avastin® (bevacizumab) waxaa oggolaatay Maamulka Cuntada iyo Dawooyinka ee Maraykanka (FDA) si loogu horumariyo daawaynta bilawga (khadka koowaad) ee daaweynta beerka sare ama metastatic Bukaanka qaba kansarka unugyada (HCC).

HCC waa nooca ugu badan ee aasaasiga ah kansarka beerka . Daaweyntan horumarineed waxay ku saleysan tahay natiijooyinka daraasad Weji Ib ah oo ku saabsan amniga iyo dhaqdhaqaaqa caafimaad ee TECENTRIQ oo ay weheliso Avastin.

Dr. Sandra Horning, oo ah madaxa caafimaadka Roche ahna madaxa horumarinta wax soo saarka adduunka, ayaa tiri: Cudurka 'Hepatocellular carcinoma', maadaama uu yahay buro xun, wuxuu leeyahay xulashooyin daaweyn oo xadidan waana sababta ugu weyn ee dhimashada adduunka. Xog hordhac ah oo ku saabsan daaweynta cudurkan TECENTRIQ iyo Avastin ayaa rajo leh. Waxaan rajeyneynaa inaan la shaqeyno waaxda caafimaadka si aan u keenno qorshahan daaweynta ee rajo-gelinta sare leh bukaannada qaba cudurka kansarka 'hepatocellular carcinoma' sida ugu dhakhsaha badan.

Magacaabista Daaweynta 'Breakthrough Therapy Designation' (BTD) waxay ujeedkeedu tahay in la dardar-geliyo horumarinta iyo dib-u-eegista daawooyinka cusub ee daaweynta cudurrada halista ah ama halista ku ah nolosha si loo hubiyo in daawooyinkaan ay ansixisay FDA sida ugu dhakhsaha badan ee looga faa'iideysto bukaannada. Kani maahan oo kaliya 22-kii BTD ee laga helay khadka wax soo saarka dawada ee Roche, laakiin sidoo kale waa kii 3-aad ee BTD ee ay heshay shirkadda TECENTRIQ.

Kooxda Roche Group waxay daabacday xog laga helay daraasada Phase Ib ee cudurka kansarka 'hepatocellular carcinoma' ee kulanka sanadlaha ah ee bulshada American ee Clinical Oncology (ASCO) bishii Juun 2018. Natiijooyinka daraasada waxay muujiyeen in dabagalka dhexdhexaadka ah ee 10.3 bilood kadib, laga saamaxay 15 (65%) oo ka mid ah 23 bukaan oo la qiimeyn karo.

After a median follow-up of 10.3 months, the median progression-free survival (PFS), duration of remission (DOR), disease progression time (TTP), and overall survival (OS) were not reached. Of the safety-evaluable patients (n = 43), 28% (n = 12) experienced grade 3-4 treatment-related adverse events, and no treatment-related grade 5 adverse events were observed.

Roche waxay bixisay xog dheeri ah iyadoo la raacayo shuruudaha FDA, waxaana lasiiyay aqoonsi heer sare ah. Ka dib helitaanka xogta la cusbooneysiiyay ee tijaabooyinka la socoshada, Roche wuxuu ku daabici doonaa natiijooyinka cilmi baarista shir caafimaad mustaqbalka.

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1) Daaweynta kansarka ee dibadda?
2) CAR T-Cell therapy
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5) daawaynta Proton