Avgust 2022: FDA tomonidan tasdiqlangan testda aniqlanganidek, o'smalari mezenximal-epitelial o'tish (MET) 14 eksonini o'tkazib yuborishga olib keladigan mutatsiyaga ega bo'lgan metastatik kichik hujayrali bo'lmagan o'pka saratoni (KHDAK) bo'lgan katta yoshli bemorlarga oziq-ovqat va farmatsevtika idorasi kapmatinib (Tabrecta) berdi. , Novartis Pharmaceuticals Corp.) muntazam tasdiqlash.
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, va 16% markaziy asab tizimiga metastazlar bo'lgan. Ilgari davolangan bemorlarning 81% tizimli terapiyaning faqat bitta qatorini olgan; 16% ikkitasini olgan; va 3% uchtasini olgan. Ilgari davolangan bemorlarning 86% platina asosidagi kimyoterapiyaga ega edi.
Bemorlarda shish, ko'ngil aynishi, mushak-skelet tizimining og'rig'i, charchoq, qusish, nafas qisilishi, yo'tal va ishtahaning pasayishi (20%) eng ko'p uchraydi.
Kapmatinibni kuniga ikki marta 400 mg dozada, ovqat bilan yoki ovqatlanmasdan ichish kerak.
Enhertu uchun to'liq retsept ma'lumotlarini ko'ring.
