2022 Agustus: Pikeun penderita sawawa kanker paru-paru sél non-leutik métastatik (NSCLC) anu tumorna gaduh mutasi anu nyababkeun transisi mesenchymal-épitélial (MET) exon 14 skipping, sakumaha anu dideteksi ku tés anu disatujuan FDA, Administrasi Pangan sareng Narkoba masihan capmatinib (Tabrekta). , Novartis Pharmaceuticals Corp) persetujuan biasa.
Dumasar kana tingkat réspon sakabéh awal sareng durasi réspon dina percobaan GEOMETRY mono-1 (NCT02414139), panalungtikan multiséntral, non-acak, open-labél, multi-cohort, capmatinib saacanna dibéré persetujuan gancangan pikeun indikasi anu sami dina Méi 6, 2020. Dumasar data tina tambahan 63 pasien sareng tambahan 22 bulan susulan pikeun ngevaluasi daya tahan réspon sareng mastikeun kauntungan terapi, konvérsi kana persetujuan biasa dilakukeun.
160 penderita NSCLC canggih kalayan mutasi skipping exon 14 of MET némbongkeun efficacy. Pasén nampi capmatinib 400 mg dua kali sadinten dugi panyakitna ningkat atanapi efek samping janten teu kaampeuh.
A Blinded Independent Review Committee nangtukeun ORR jeung durasi respon (DOR) salaku ukuran efficacy utama (BIRC). 60 jalma anu henteu kantos nampi perlakuan ngagaduhan ORR 68% (95% CI: 55, 80) sareng DOR 16.6 bulan (95% CI: 8.4, 22.1). The ORR éta 44% (95% CI: 34, 54) diantara 100 penderita anu saméméhna geus narima perlakuan, sarta DOR éta 9.7 bulan (95% CI: 5.6, 13).
The patients’ average age was 71 years (48 to 90). The following specific demographics were reported: 61% female, 77% White, 61% never smoked, 83% had adénokarsinoma, and 16% had metastases to the central nervous system. 81% of patients who had previously had treatment had only gotten one line of systemic therapy; 16% had received two; and 3% had received three. 86% of patients who had previously had treatment had platinum-based chemotherapy.
Pasén ngalaman edema, seueul, nyeri musculoskeletal, kacapean, utah, dyspnea, batuk, sareng panurunan napsu paling sering (20%).
Capmatinib kedah dicandak sacara lisan dua kali sadinten dina dosis 400 mg, sareng atanapi tanpa tuangeun.
Ningali inpormasi resep lengkep pikeun Tabrecta
