Dahareun sareng Administrasi Narkoba (FDA) nyatujuan Encorafenib (Braftovi, Array BioPharma Inc., anak perusahaan milik Pfizer) sareng binimetinib (Mektovi, Array BioPharma Inc.) dina bulan Nopémber 2023 salaku ubar anu tiasa dianggo pikeun ngubaran déwasa kalayan metastatik non-leutik. kanker paru sél (NSCLC) sareng mutasi BRAF V600E, anu dipendakan ku uji anu disatujuan FDA.
FDA ogé nyatujuan FoundationOne CDx (jaringan) jeung FoundationOne Liquid CDx (plasma) salaku diagnostics pendamping pikeun encorafenib ditéang jeung binimetinib. Nguji jaringan tumor diperyogikeun upami spésimén plasma henteu nunjukkeun mutasi.
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.
Panitia review bebas ngaevaluasi durasi respon (DoR) jeung laju respon obyektif (ORR), nu éta indikator utama efektivitas. The ORR éta 75% (95% CI: 62, 85) diantara 59 penderita perlakuan-naif, sedengkeun DoR median teu estimable (NE) dina 95% (95% CI: 23.1, NE). ORR nyaéta 46% (95% CI: 30, 63) diantara 39 pasien anu parantos dirawat sateuacana, sareng median DoR nyaéta 16.7 bulan (95% CI: 7.4, NE).
Kacapean, seueul, diare, nyeri musculoskeletal, utah, nyeri beuteung, impairment visual, kabebeng, dyspnea, dermatitis, sarta batuk éta épék ngarugikeun paling sering (25 persen atawa leuwih).
For NSCLC mutated to BRAF V600E, the recommended oral doses of encorafenib 450 mg once daily and binimetinib 45 mg twice daily are administered.
Ningali inpormasi resep lengkep pikeun Braftovi sareng Mektovi.
