Chikafu uye Drug Administration (FDA) yakabvumidza Encorafenib (Braftovi, Array BioPharma Inc., inotsigirwa nePfizer) uye binimetinib (Mektovi, Array BioPharma Inc.) muna Mbudzi 2023 semishonga inogona kushandiswa kurapa vanhu vakuru vane metastatic isiri-diki. cell lung cancer (NSCLC) uye BRAF V600E mutation, iyo yakawanikwa neFDA-yakatenderwa bvunzo.
Iyo FDA yakabvumidzawo FoundationOne CDx (tissue) uye FoundationOne Liquid CDx (plasma) seshamwari yekuongorora encorafenib pamwe chete nebinimetinib. Kuongororwa kwebundu tishu kunodiwa kana plasma sampuli isingaratidze chero shanduko.
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.
Dare rekuongorora rakazvimiririra rakaongorora nguva yekupindura (DoR) uye chinangwa chekupindura (ORR), izvo zvaive zviratidzo zvikuru zvekushanda. IORR yaiva 75% (95% CI: 62, 85) pakati pevarwere ve59 vasina kurapwa, nepo DoR yepakati yakanga isingafungidziki (NE) pa95% (95% CI: 23.1, NE). Iyo ORR yaive 46% (95% CI: 30, 63) pakati pevarwere makumi matatu nevapfumbamwe vakamborapwa, uye yepakati DoR yaive mwedzi 39 (16.7% CI: 95, NE).
Kuneta, kusvotwa, manyoka, kurwadziwa kwetsandanyama, kurutsa, kurwadziwa mudumbu, kusaona zvakanaka, kuvimbiswa, dyspnea, dermatitis, uye kukosora ndizvo zvaiwanzoita zvakaipa (25 muzana kana kupfuura).
For NSCLC mutated to BRAF V600E, the recommended oral doses of encorafenib 450 mg once daily and binimetinib 45 mg twice daily are administered.