Abincin da Gudanar da Magunguna (FDA) sun amince da Encorafenib (Braftovi, Array BioPharma Inc., wani kamfani na Pfizer gabaɗaya) da binimetinib (Mektovi, Array BioPharma Inc.) a cikin Nuwamba 2023 a matsayin magungunan da za a iya amfani da su don kula da manya tare da ƙananan ƙananan ƙwayoyin cuta. Ciwon daji na huhu (NSCLC) da maye gurbin BRAF V600E, wanda aka samo ta hanyar gwajin da aka yarda da FDA.
FDA ta kuma amince da FoundationOne CDx (nama) da FoundationOne Liquid CDx (plasma) a matsayin abokin bincike don encorafenib tare da binimetinib. Gwajin ƙwayar ƙwayar cuta ya zama dole idan samfurin plasma bai bayyana wani maye gurbi ba.
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.
Kwamitin bita mai zaman kansa ya kimanta tsawon lokacin amsawa (DoR) da ƙimar amsa haƙiƙa (ORR), waɗanda sune manyan alamomin tasiri. ORR ya kasance 75% (95% CI: 62, 85) a tsakanin marasa lafiya na 59 marasa lafiya, yayin da DoR na tsaka-tsaki ba shi da ƙima (NE) a 95% (95% CI: 23.1, NE). ORR shine 46% (95% CI: 30, 63) tsakanin marasa lafiya 39 da aka yi musu magani a baya, kuma DoR na tsakiya shine watanni 16.7 (95% CI: 7.4, NE).
Gajiya, tashin zuciya, zawo, ciwon musculoskeletal, amai, ciwon ciki, nakasar gani, maƙarƙashiya, dyspnea, dermatitis, da tari sun kasance mafi yawan m illa (25 kashi ko fiye).
For NSCLC mutated to BRAF V600E, the recommended oral doses of encorafenib 450 mg once daily and binimetinib 45 mg twice daily are administered.
