Agusta 2022: Ga manya marasa lafiya masu ciwon huhu marasa ƙananan ƙwayoyin cuta (NSCLC) waɗanda ciwace-ciwacen su ke da maye gurbi wanda ya haifar da mizanin mizanin-epithelial (MET) exon 14 skipping, kamar yadda gwajin da FDA ta amince da shi, Hukumar Abinci da Magunguna ta ba capmatinib (Tabrecta). , Novartis Pharmaceuticals Corp.) amincewa na yau da kullum.
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 adenocarcinoma, kuma 16% sun sami metastases zuwa tsarin juyayi na tsakiya. 81% na marasa lafiya da suka riga sun sami magani sun sami layi ɗaya kawai na tsarin tsarin tsarin; 16% sun sami biyu; kuma 3% sun sami uku. Kashi 86% na marasa lafiya waɗanda a baya suna da magani suna da maganin cutar sankarau na tushen platinum.
Marasa lafiya sun fuskanci edema, tashin zuciya, ciwon musculoskeletal, gajiya, amai, dyspnea, tari, da rage cin abinci akai-akai (20%).
Capmatinib ya kamata a sha baki sau biyu a rana a kashi na 400 MG, tare da ko ba tare da abinci ba.
Duba cikakken bayanin rubutawa don Enhertu.
