Febraayo 2023: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) waxaa la siiyay ogolaanshaha FDA si loogu daweeyo bukaanada qaangaarka ah ee qaba cillad la'aanta dayactirka (dMMR) ee soo noqnoqda ama sare u kaca kansarka endometrial kaas oo horumaray intii lagu jiray ama ka dib nidaam hore oo platinum ku jira goob kasta oo aan u sharaxin qalliinka daaweynta ama shucaaca, sida lagu go'aamiyay Tijaabada FDA-ansixisay.
Dostarlimab-gxly waxay heshay oggolaansho degdeg ah Abriil 2021 ee bukaannada qaangaarka ah ee qaba dMMR soo noqnoqda ama kansarka endometrial ee horumaray intii lagu jiray ama ka dib daawaynta ka kooban platinum, sida lagu go'aamiyay baaritaanka FDA-ansixisay.
GARNET (NCT02715284), xarun-badan, koox-kooxeedyo badan, tijaabo sumad-furan oo lagu sameeyay bukaannada qaba burooyinka adag ee horumarsan, ayaa baadhay waxtarka oggolaanshaha caadiga ah. Koox ka kooban 141 bukaan oo qaba dMMR kansarka endometrial oo soo noqnoqday ama sare u maray kuwaas oo soo maray intii lagu jiray ama ka dib markii la helay daawaynta platinum-ku-jirta ayaa ka dhigay dadka waxtarka leh. Bukaannada dhawaan helay dawooyinka difaaca jirka ee jirrooyinka difaaca jirka ama kuwa hore u helay unugyada difaaca jirka ee PD-1/PD-LI ama kuwa kale ee isbaarada difaaca ayaa laga saaray.
Heerka jawaabta guud (ORR) iyo muddada jawaabta (DOR), sida lagu go'aamiyay indho-indheynta dib-u-eegista dhexe ee madax-bannaanida sida waafaqsan RECIST v1.1, ayaa ahaa tallaabooyinka waxtarka leh ee muhiimka ah. ORR la xaqiijiyay wuxuu ahaa 45.4% (95% CI: 37.0, 54.0), iyadoo 15.6% jawaab bixiyaasha ay si buuxda uga jawaabeen iyo 29.8% qayb ahaan u jawaabay. Iyadoo 85.9% bukaanada ay leeyihiin mudo ka yar 12 bilood iyo 54.7% oo leh mudo ka badan 24 bilood (kala duwan: 1.2+, 52.8+), dhexdhexaadka DOR lama kulmin.
The most frequent negative effects (20%) were asthenia/fatigue, anaemia, rash, nausea, diarrhoea, and vomiting. Pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal failure, and skin adverse reactions are examples of immune-mediated adverse reactions that can happen.
Qiyaasaha 1 ilaa 4 ee dostarlimab-gxly waa in lagu bixiyaa qiyaas iyo jadwal ah 500 mg saddexdii toddobaadba mar. Qiyaasta xigta waa 1,000 mg 6 asbuuc kasta laga bilaabo 3 usbuuc ka dib qiyaasta 4, sii socota ilaa uu cudurku ka sii socdo ama uu jiro waxyeelo aan loo dulqaadan karin. Dostarlimab-gxly waa in xididka la siiyo muddo 30 daqiiqo ah.
U fiirso macluumaadka dhamaystiran ee Jemperli.
