August 2022: Bukaannada qaangaarka ah ee qaba kansarka sambabada unugyada yaryar ee dheef-shiid kiimikaadka (NSCLC) kuwaas oo burooyinkoodu ay leeyihiin isbeddel taasoo keentay kala-guurka mesenchymal-epithelial (MET) exon 14, sida lagu ogaaday baaritaanka FDA-ansixisay, Maamulka Cuntada iyo Dawooyinka ayaa siiyay capmatinib (Tabrecta). , Novartis Pharmaceuticals Corp.) oggolaanshaha joogtada ah.
Capmatinib was given fast approval for the same use on May 6, 2020, based on the overall response rate and length of response in the GEOMETRY mono-1 trial (NCT02414139), a multicenter, non-randomized, open-label, multi-cohort research study. Based on data from an additional 63 patients and an additional 22 months of follow-up to evaluate response durability and confirm therapeutic benefit, the conversion to regular approval was made.
160 patients with advanced NSCLC with a mutation skipping exon 14 of MET showed efficacy. Patients received capmatinib 400 mg twice a day until their disease progressed or the side effects became intolerable.
A Blinded Independent Review Committee (BIRC) determined the ORR and duration of response (DOR) as the major efficacy measures (BIRC). 60 individuals who had never received treatment had an ORR of 68% (95% CI: 55, 80) and a DOR of 16.6 months (95% CI: 8.4, 22.1). The ORR was 44% (95% CI: 34, 54) among 100 patients who had previously received treatment, and the DOR was 9.7 months (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, iyo 16% waxay qabeen metastases habka dhexe ee neerfayaasha. 81% bukaanada hore loo daaweeyay waxay heleen hal xariiq oo daawaynta habaysan; 16% waxay heleen laba; oo 3% ay heleen saddex. 86% bukaanada hore loo daaweeyay waxay haysteen kiimoterabi platinum ku salaysan.
Bukaanku waxay la kulmeen edoema, lallabbo, xanuun murqo-xanuun, daal, matag, dyspnea, qufac, iyo rabitaanka cuntada oo hoos u dhacay inta badan (20%).
Capmatinib waa in afka laga qaataa laba jeer maalintii qiyaasta 400 mg, cunto la'aan ama la'aan.
U fiirso macluumaadka dhamaystiran ee Enhertu.
