Ovqat va farmatsevtika idorasi (FDA) 2023-yil noyabr oyida Encorafenib (Braftovi, Array BioPharma Inc., Pfizer’ning 600 XNUMX sho‘ba korxonasi) va binimetinibni (Mektovi, Array BioPharma Inc.) metastatik bo‘lmagan kichik bo‘lmagan kattalarni davolashda qo‘llanilishi mumkin bo‘lgan dorilar sifatida tasdiqladi. hujayrali o'pka saratoni (NSCLC) va FDA tomonidan tasdiqlangan test tomonidan topilgan BRAF VXNUMXE mutatsiyasi.
FDA, shuningdek, FoundationOne CDx (to'qima) va FoundationOne Liquid CDx (plazma) ni binimetinib bilan birgalikda enkorafenib uchun qo'shimcha diagnostika sifatida tasdiqladi. Plazma namunasi mutatsiyalarni aniqlamasa, o'simta to'qimasini tekshirish kerak.
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.
Mustaqil tekshiruv qo'mitasi samaradorlikning asosiy ko'rsatkichlari bo'lgan javob muddati (DoR) va ob'ektiv javob tezligini (ORR) baholadi. Davolanmagan 75 bemor orasida ORR 95% (62% CI: 85, 59), o'rtacha DoR esa 95% (95% CI: 23.1, NE) da baholanmaydi. Oldin davolangan 46 bemor orasida ORR 95% (30% CI: 63, 39) va o'rtacha DoR 16.7 oyni (95% CI: 7.4, NE) tashkil etdi.
Charchoq, ko'ngil aynishi, diareya, mushak-skelet tizimining og'rig'i, qusish, qorin og'rig'i, ko'rishning buzilishi, ich qotishi, nafas qisilishi, dermatit va yo'tal eng ko'p uchraydigan nojo'ya ta'sirlar (25 foiz va undan ko'p) edi.
For NSCLC mutated to BRAF V600E, the recommended oral doses of enkorafenib 450 mg once daily and binimetinib 45 mg twice daily are administered.
Braftovi va Mektovi uchun retsept bo'yicha to'liq ma'lumotni ko'ring.
