Agustus 2022: Untuk pasien dewasa dengan kanker paru-paru non-sel kecil metastatik (NSCLC) yang tumornya memiliki mutasi yang mengakibatkan transisi mesenchymal-epithelial (MET) ekson 14 yang dilewati, seperti yang terdeteksi oleh tes yang disetujui FDA, Food and Drug Administration memberikan capmatinib (Tabrecta , Novartis Pharmaceuticals Corp.) persetujuan reguler.
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% mengalami metastasis ke sistem saraf pusat. 81% pasien yang sebelumnya menjalani pengobatan hanya mendapatkan satu lini terapi sistemik; 16% telah menerima dua; dan 3% telah menerima tiga. 86% pasien yang sebelumnya menjalani pengobatan menjalani kemoterapi berbasis platinum.
Pasien paling sering mengalami edema, mual, nyeri muskuloskeletal, kelelahan, muntah, dispnea, batuk, dan nafsu makan menurun (20%).
Capmatinib harus diminum dua kali sehari dengan dosis 400 mg, dengan atau tanpa makan.
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