Ukudla kanye neDrug Administration (FDA) igunyaze i-Encorafenib (i-Braftovi, i-Array BioPharma Inc., inkampani ephethwe ngokuphelele ye-Pfizer) kanye ne-binimetinib (Mektovi, Array BioPharma Inc.) ngoNovemba 2023 njengemithi engasetshenziswa ukwelapha abantu abadala abane-metastatic engeyona encane. umdlavuza wamaphaphu weseli (NSCLC) kanye nokuguqulwa kwe-BRAF V600E, okutholwe ukuhlolwa okugunyazwe yi-FDA.
I-FDA iphinde yagunyaza i-FoundationOne CDx (tissue) kanye ne-FoundationOne Liquid CDx (plasma) njengokuxilonga okuhambisanayo kwe-enorafenib ngokuhlangana ne-binimetinib. Ukuhlolwa kwezicubu zesimila kuyadingeka uma isampula ye-plasma ingavezi noma yiziphi izinguquko.
The open-label, multicenter, single-arm PHAROS (NCT03915951) study looked at 98 people with metastatic NSCLC and the BRAF V600E mutation. The study’s effectiveness was tested on these people. Prior use of inhibitors of BRAF or MEK was prohibited. Encorafenib and ibinimetinib were administered to patients until disease progression or unacceptable toxicity occurred.
Ikomidi elibuyekezayo elizimele lihlole ubude besikhathi sokuphendula (DoR) kanye nezinga lokuphendula lenhloso (ORR), okwakuyizinkomba eziyinhloko zokusebenza ngempumelelo. I-ORR yayingama-75% (95% CI: 62, 85) phakathi kweziguli ezingama-59 ezingenazo ukwelashwa, kuyilapho i-DoR emaphakathi yayingalinganiselwe (NE) ku-95% (95% CI: 23.1, NE). I-ORR yayingama-46% (95% CI: 30, 63) phakathi kweziguli ezingama-39 ezake zelashwa ngaphambilini, kanti i-DoR emaphakathi yayiyizinyanga eziyi-16.7 (95% CI: 7.4, NE).
Ukukhathala, isicanucanu, isifo sohudo, ubuhlungu bemisipha namathambo, ukuhlanza, ubuhlungu besisu, ukungaboni kahle, ukuqunjelwa, i-dyspnea, i-dermatitis, nokukhwehlela kwakuyimiphumela emibi kakhulu evame kakhulu (amaphesenti angama-25 noma ngaphezulu).
For NSCLC mutated to BRAF V600E, the recommended oral doses of encorafenib 450 mg once daily and binimetinib 45 mg twice daily are administered.
