August 2022: Pentru pacienții adulți cu cancer pulmonar fără celule mici (NSCLC) metastatic ale căror tumori au o mutație care duce la omiterea exonului 14 de tranziție mezenchimato-epitelială (MET), așa cum a fost detectat de un test aprobat de FDA, Food and Drug Administration a dat capmatinib (Tabrecta). , Novartis Pharmaceuticals Corp.) aprobare regulată.
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 adenocarcinom, iar 16% au avut metastaze la sistemul nervos central. 81% dintre pacienții care au avut anterior tratament au primit doar o singură linie de terapie sistemică; 16% primiseră două; iar 3% primiseră trei. 86% dintre pacienții care au avut anterior tratament au primit chimioterapie pe bază de platină.
Pacienții au prezentat cel mai frecvent edoemă, greață, dureri musculo-scheletice, oboseală, vărsături, dispnee, tuse și scăderea apetitului (20%).
Capmatinib trebuie administrat oral de două ori pe zi, în doză de 400 mg, cu sau fără mese.
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