De Victus et Drug Administration (FDA) approbavit Encorafenib (Braftovi, Array BioPharma Inc., subsidiaria omnino possessa Pfizer) et binimetinib (Mektovi, Array BioPharma Inc.) mense Novembri 2023 ut medicamenta quae tractari possunt adultis metastaticis non parvis cancer pulmonis cellae (NSCLC) et mutatio BRAF V600E, quae inventa est ab experimento FDA probato.
FDA approbavit etiam FoundationOne CDx et FoundationOne Liquidum CDx (plasma) ut comes diagnostica pro encorafenib in conjunctione cum binimetinib. Probatio tumoris textus necessaria est si specimen plasmatis quaslibet mutationum patefacit.
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 binmetinib were administered to patients until disease progression or unacceptable toxicity occurred.
Commissio independentis recensionis aestimata durationem responsionis (DoR) et responsionis obiectivae (ORR), quae praecipua indicia efficaciae fuerunt. ORR 75% (95% CI: 62, 85) inter 59 curationes simplices aegros erat, mediana DoR non aestimabilis (NE) ad 95% (95% CI: 23.1, NE). ORR erat 46% (95% CI: 30, 63) inter 39 aegros qui antea curati erant et medius DoR 16.7 mensis erat (95% CI: 7.4, NE).
Lassio, nausea, diarrhoea, dolor musculoskeletalis, vomitus, dolor abdominis, defectus visualis, constipatio, dyspnoea, dermatitis, et tussis frequentiores sunt effectus adversae (25 percent vel plures).
For NSCLC mutated to BRAF V600E, the recommended oral doses of encorafenib 450 mg once daily and binimetinib 45 mg twice daily are administered.
