2022 Ogos: Bagi pesakit dewasa dengan kanser paru-paru bukan sel kecil metastatik (NSCLC) yang tumornya mempunyai mutasi yang mengakibatkan peralihan mesenchymal-epithelial transition (MET) ekson 14 melangkau, seperti yang dikesan oleh ujian yang diluluskan oleh FDA, Pentadbiran Makanan dan Ubat-ubatan memberikan capmatinib (Tabrecta). , Novartis Pharmaceuticals Corp.) kelulusan tetap.
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 adenokarsinoma, dan 16% mempunyai metastasis ke sistem saraf pusat. 81% pesakit yang sebelum ini mendapat rawatan hanya mendapat satu baris terapi sistemik; 16% telah menerima dua; dan 3% telah menerima tiga. 86% pesakit yang pernah menjalani rawatan sebelum ini mempunyai kemoterapi berasaskan platinum.
Pesakit mengalami edoema, loya, sakit muskuloskeletal, letih, muntah, sesak nafas, batuk, dan kurang selera makan paling kerap (20%).
Capmatinib perlu diambil secara lisan dua kali sehari pada dos 400 mg, dengan atau tanpa makan.
Lihat maklumat preskripsi penuh untuk Enhertu.
