Iyul: 2022: Dabrafenib (Tafinlar, Novartis) va trametinib (Mekinist, Novartis) BRAF V6E mutatsiyasiga ega rezektsiya qilinib bo'lmaydigan yoki metastatik qattiq o'smalari bo'lgan 600 yoshdan katta kattalar va pediatrik bemorlarni davolash uchun oziq-ovqat va farmatsevtika idorasidan tezlashtirilgan ruxsatnoma oldi, ular oldingi terapiyadan so'ng kuchaygan va boshqa mos davolash usullari mavjud emas. Kolorektal saraton bilan og'rigan bemorlarga dabrafenib va trametinib BRAF inhibisyoniga ma'lum bo'lgan ichki qarshilik tufayli tavsiya etilmaydi. BRAF yovvoyi tipidagi qattiq o'smalari bo'lgan bemorlarga dabrafenibni qabul qilish tavsiya etilmaydi.
36 paediatric patients from CTMT212X2101 (NCT02124772), 131 adult patients from open-label, multiple cohort trials BRF117019 (NCT02034110) and NCI-MATCH (NCT02465060), and results from COMBI-d, COMBI-v, and BRF113928 were used to evaluate the safety and efficacy (studies in melanoma and lung cancer already described in product labeling). Patients with certain solid tumours, such as high grade glioma (HGG), biliary tract cancer, low grade glioma (LGG), small intestinal adenocarcinoma, gastrointestinal stromal tumour, and anaplastic thyroid cancer, that are positive for the BRAF V600E mutation were enrolled in the study BRF117019 (ATC). Except for patients with melanoma, thyroid cancer, or kolorektal saraton, NCI-MATCH Subprotocol H recruited adult patients with BRAF V600E mutation positive solid tumours. A total of 36 paediatric patients with BRAF V600 refractory or recurrent LGG or HGG were included in Parts C and D of Study CTMT212X2101. The overall response rate (ORR) utilising conventional response criteria served as the trials’ primary efficacy outcome measure. A total of 54 (41 percent, 95 percent CI: 33, 50) of the 131 adult patients showed an objective response. Patients with 24 distinct tumour types, including several subtypes of LGG and HGG, were enrolled in the study. Among the most prevalent tumour forms, the ORR for biliary tract cancer was 46% (95% CI: 31, 61), for combined high grade glioma it was 33% (95% CI: 20, 48), and for low grade gliomas it was 50% (95% CI: 23, 77). (combined). The ORR for the 36 paediatric patients was 25% (95% CI: 12, 42); the DOR was 6 months or less for 78 percent of patients and 24 months or less for 44 percent.
Voyaga etgan bemorlarda pireksiya, charchoq, ko'ngil aynishi, toshma, titroq, bosh og'rig'i, qon ketish, yo'tal, qusish, ich qotishi, diareya, miyalji, artralgiya va shish paydo bo'lgan (20%).
Pediatrik bemorlarda pireksiya, toshma, qusish, charchoq, quruq teri, yo'tal, diareya, akneiform dermatit, bosh og'rig'i, oshqozon og'rig'i, ko'ngil aynishi, qon ketishi, ich qotishi va paronixiya eng ko'p uchraydigan nojo'ya ta'sirlar (20%).
Voyaga etgan bemorlar kuniga bir marta og'iz orqali 2 mg trametinib va kuniga ikki marta 150 mg (ikki 75 mg kapsula) dabrafenibni qabul qilishlari kerak. Tana vazniga qarab, pediatrik bemorlar trametinib va dabrafenibni tegishli dozalarda qabul qilishlari kerak. Og'irligi 26 kg dan kam bo'lgan bemorlar uchun belgilangan doza yo'q.
View full prescribing information for Tafinlar and Mekinist
