2022 Juli: Dabrafenib (Tafinlar, Novartis) jeung trametinib (Mekinist, Novartis) nampi persetujuan gancangan ti Administrasi Pangan sareng Narkoba pikeun pengobatan pasien dewasa sareng murangkalih langkung lami ti 6 taun kalayan tumor padet anu teu tiasa direseksi atanapi métastatik kalayan mutasi BRAF V600E anu parantos maju saatos nampi terapi sateuacanna sareng teu gaduh pilihan perawatan anu sanés. Pikeun individu kalawan kanker kolorektal, dabrafenib na trametinib teu dianjurkeun alatan résistansi intrinsik dipikawanoh pikeun inhibisi BRAF. Pasien sareng tumor padet anu tipe liar BRAF henteu disarankeun nyandak dabrafenib.
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 kangker colorectal, 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.
Pasén déwasa ngalaman pyrexia, kacapean, seueul, baruntus, chills, nyeri sirah, perdarahan, batuk, utah, kabebeng, diare, myalgia, artralgia, sarta edema paling sering (20%).
Diantara pasien murangkalih, pyrexia, ruam, utah, kacapean, kulit garing, batuk, diare, dermatitis acneiform, nyeri sirah, nyeri beuteung, seueul, perdarahan, kabebeng, sareng paronychia mangrupikeun efek samping anu paling sering (20%).
Pasién sawawa kedah nyandak trametinib 2 mg sacara lisan sakali dinten sareng 150 mg (dua kapsul 75 mg) dabrafenib dua kali sadinten. Dumasar beurat awak, penderita murangkalih kedah nyandak trametinib sareng dabrafenib dina dosis anu pas. Pikeun pasien anu beuratna kirang ti 26 kg, teu aya dosis anu diatur.
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