Dostarlimab-gxly waxay ogolaansho degdeg ah ka heshaa FDA ee kansarka endometrial dMMR

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August 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) ka helay oggolaanshaha degdega ah Maamulka Cuntada iyo Dawooyinka ee bukaanada qaangaarka ah ee leh cillad la'aanta dayactirka (dMMR) ee soo noqnoqda ama sare u kaca kansarka endometrial, sida lagu go'aamiyay baaritaanka FDA-ay ansixisay, kuwaas oo ku hormaray ama ka dib nidaam hore oo platinum ku jira.

Tijaabada GARNET (NCT02715284), xarun-badan, koox-kooxeedyo badan, tijaabo sumad-furan oo bukaanno qaba burooyin adag oo horumarsan, waxtarka ayaa la qiimeeyay iyadoo ku xiran kooxda (A1). 71 bukaan oo qaba dMMR kansarka endometrial ee soo noqnoqda ama sare u kacay ee ku socday ama ka dib daawaynta ku jirta platinum ayaa lagu daray dadka waxtarka leh. Bukaan-socodka ayaa la siiyay 500 mg oo ah dostarlimab-gxly xididka saddexdii toddobaadba mar afar qiyaasood, ka dibna 1,000 mg xididka lixdii toddobaadba mar.

Heerka jawaabta guud (ORR) iyo muddada jawaabta (DOR) ayaa ahaa natiijooyinka waxtarka aasaasiga ah, sida lagu go'aamiyay dib-u-eegis dhexe oo madax-bannaan oo indho-la'aan ah (BICR) sida waafaqsan RECIST 1.1. ORR waxaa la xaqiijiyay inuu yahay 42.3 boqolkiiba (95 boqolkiiba CI: 30.6 boqolkiiba, 54.6 boqolkiiba). Heerka jawaabta ayaa ahaa 12.7 boqolkiiba jawaabaha dhamaystiran iyo 29.6 boqolkiiba jawaabaha aan dhamaystirnayn. Iyadoo 93.3 boqolkiiba bukaanada ay haystaan ​​muddo ka yar lix bilood, dhexdhexaadka DOR lama buuxin (qiyaastii: 2.6 ilaa 22.4 bilood, oo socota qiimayntii u dambaysay).

In 34 percent of individuals who received dostarlimab-gxly, serious side effects occurred. Sepsis, acute renal injury, urinary tract infection, abdominal discomfort, and pyrexia were among the serious adverse responses experienced by more than 2% of patients. Fatigue/asthenia, nausea, diarrhoea, anaemia, and constipation were the most prevalent side effects (20%). Anemia and elevated transaminases were the most common grade 3 or 4 adverse events (2%). Pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis are all immune-mediated adverse responses that might occur.

Waxaa laga yaabaa inaad jeceshahay inaad akhriso: Daweynta Kansarka ee Hindiya

Dostarlimab-gxly 500 mg 3 asbuuc kasta waa qiyaasta lagu taliyey iyo jadwalka (qiyaasyada 1 ilaa 4). Laga bilaabo saddex toddobaad ka dib qiyaasta 4, qiyaasta waxaa la kordhiyaa ilaa 1,000 mg lixdii toddobaadba mar ilaa cudurku ka sii socdo ama sunta aan loo dulqaadan karin. Dostarlimab-gxly waa in la keenaa sida faleebo 30-daqiiqo ah oo xidid ah.

Tixraac: https://www.fda.gov/

Fiiri faahfaahinta halkan.

Qaado ra'yi labaad oo ku saabsan daaweynta kansarka endometrial


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