Cuntada iyo Maamulka Dawooyinka (FDA) waxay ansixiyeen Encorafenib (Braftovi, Array BioPharma Inc., oo ah shirkad ay iska leedahay Pfizer) iyo binimetinib (Mektovi, Array BioPharma Inc.) bishii Noofambar 2023 sida dawooyin loo isticmaali karo in lagu daweeyo dadka waaweyn ee qaba metastatic aan yareyn. Kansarka sambabada unugyada (NSCLC) iyo isbeddelka BRAF V600E, kaas oo lagu helay baaritaan ay oggolaatay FDA.
FDA waxay kaloo ansixisay FoundationOne CDx (unug) iyo FoundationOne Liquid CDx (plasma) sida saaxiibka ogaanshaha ee encorafenib iyadoo lala kaashanayo binimetinib. Baaritaanka nudaha burada waa lagama maarmaan haddii shaybaarka balasmaha uusan muujin wax isbedel ah.
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 binimetinib were administered to patients until disease progression or unacceptable toxicity occurred.
Guddi dib u eegis madaxbannaan ayaa qiimeeyay muddada jawaabta (DoR) iyo heerka jawaabta ujeeddada (ORR), kuwaas oo ahaa tilmaamayaasha ugu muhiimsan ee waxtarka. ORR wuxuu ahaa 75% (95% CI: 62, 85) oo ka mid ah bukaannada 59-daawaynta, halka dhexdhexaadka DoR aan la qiyaasi karin (NE) 95% (95% CI: 23.1, NE). ORR wuxuu ahaa 46% (95% CI: 30, 63) oo ka mid ah bukaannada 39 ee hore loo daweeyay, iyo dhexdhexaadiyaha DoR wuxuu ahaa 16.7 bilood (95% CI: 7.4, NE).
Daal, lallabbo, shuban, muruq xanuun, matag, calool xanuun, arag la'aan, calool istaag, dyspnea, dermatitis, iyo qufac ayaa ahaa saamaynta xun ee soo noqnoqda (25 boqolkiiba ama ka badan).
For NSCLC mutated to BRAF V600E, the recommended oral doses of encorafenib 450 mg once daily and binimetinib 45 mg twice daily are administered.
U fiirso macluumaadka dawaynta oo dhamaystiran Braftovi iyo Mektovi.
