August 2022: Kune varwere vakuru vane metastatic isiri-diki cell yemapapu cancer (NSCLC) vane mabundu ane shanduko inokonzeresa mesenchymal-epithelial transition (MET) exon 14 kusvetuka, sezvaonekwa neFDA-yakatenderwa bvunzo, iyo Food and Drug Administration yakapa capmatinib (Tabrecta). , Novartis Pharmaceuticals Corp.) mvumo yenguva dzose.
Capmatinib yakapihwa mvumo yekukurumidza kushandiswa kumwe chete muna Chivabvu 6, 2020, zvichibva pachiyero chemhinduro uye kureba kwemhinduro muGEOMETRY mono-1 muedzo (NCT02414139), yakawanda, isina-randomized, yakavhurika-label, yakawanda-cohort. tsvakurudzo kudzidza. Kubva pane data kubva kune vamwe varwere ve63 uye imwezve mwedzi ye22 yekutevera kuti uongorore kusimba kwekupindura uye kusimbisa rubatsiro rwekurapa, kutendeuka kune kubvumirwa nguva dzose kwakaitwa.
Varwere 160 vane NSCLC yepamusoro ine mutation skipping exon 14 yeMET yakaratidza kushanda. Varwere vakagamuchira capmatinib 400 mg kaviri pazuva kusvikira chirwere chavo chichifambira mberi kana kuti migumisiro yakave isingagoneki.
Blinded Independent Ongororo Komiti (BIRC) yakasarudza ORR uye nguva yekupindura (DOR) seyakanyanya kushanda matanho (BIRC). 60 vanhu vakanga vasati vambogamuchira kurapwa vaiva neORR ye68% (95% CI: 55, 80) uye DOR yemwedzi 16.6 (95% CI: 8.4, 22.1). IORR yaiva 44% (95% CI: 34, 54) pakati pevarwere ve100 vakanga vambogamuchira kurapwa, uye DOR yaiva mwedzi 9.7 (95% CI: 5.6, 13).
The patients’ average age was 71 years (48 to 90). The following specific demographics were reported: 61% female, 77% were white, 61% never smoked, 83% had adenocarcinoma, uye 16% yakanga ine metastases kune yepakati tsinga system. 81% yevarwere vakanga vamborapwa vakanga vangowana mutsara mumwe chete we systemic therapy; 16% yakanga yawana maviri; uye 3% yakanga yawana matatu. 86% yevarwere vakamborapwa vaine platinum-based chemotherapy.
Varwere vakawana edoema, kusvotwa, kurwadziwa kwetsandanyama, kuneta, kurutsa, dyspnea, kukosora, uye kuderera kwechido kazhinji (20%).
Capmatinib inofanira kutorwa nemuromo kaviri zuva nezuva pamuyero we400 mg, pamwe kana pasina kudya.
Wona ruzivo rwakazara rwekurayira Enhertu.