Agosto 2022: Para los pacientes adultos con cáncer de pulmón de células no pequeñas (CPCNP) metastásico cuyos tumores tienen una mutación que provoca la omisión del exón 14 de la transición mesenquimatosa-epitelial (MET), detectada mediante una prueba aprobada por la FDA, la Administración de Alimentos y Medicamentos administró capmatinib (Tabrecta , Novartis Pharmaceuticals Corp.) aprobación regular.
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 adenocarcinomay el 16% tenía metástasis en el sistema nervioso central. El 81% de los pacientes que habían recibido tratamiento anteriormente solo habían recibido una línea de terapia sistémica; el 16% había recibido dos; y el 3% había recibido tres. El 86% de los pacientes que habían recibido tratamiento previamente recibieron quimioterapia basada en platino.
Los pacientes experimentaron edema, náuseas, dolor musculoesquelético, cansancio, vómitos, disnea, tos y disminución del apetito con mayor frecuencia (20%).
Capmatinib debe tomarse por vía oral dos veces al día a una dosis de 400 mg, con o sin comidas.
Vea la información de prescripción completa de Enhertu.
