July 2022: Dabrafenib (Tafinlar, Novartis) uye trametinib (Mekinist, Novartis) yakagamuchira mvumo yekukurumidza kubva kuChikafu neDrug Administration yekurapwa kwevakuru nevana vane makore anopfuura matanhatu ekuzvarwa vasina marara kana metastatic tumarara mamota ane BRAF V6E mutation akafambira mberi mushure mekumborapwa uye vasina dzimwe nzira dzekurapa dzakakodzera. Kune vanhu vane colorectal cancer, dabrafenib uye trametinib hazvikurudzirwe nekuda kwekuzivikanwa kwemukati kuramba BRAF inhibition. Varwere vane mamota akasimba ari BRAF musango-mhando havakurudzirwe kutora 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 kenza yakajeka, 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 gliomas 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.
Varwere vakura vaiva nepyrexia, kuneta, kuda kurutsa, mapundu, kutonhora, musoro, kubuda ropa, chikosoro, kurutsa, kuvimbiswa, manyoka, myalgia, arthralgia, uye edoema kakawanda (20%).
Pakati pevarwere vevana, pyrexia, mapundu, kurutsa, kuneta, ganda rakaoma, chikosoro, manyoka, dermatitis acneiform, kutemwa nemusoro, kurwadziwa nemudumbu, kusvotwa, kubuda ropa, kupererwa neropa, uye paronychia ndizvo zvaiwanzoitika (20%).
Varwere vakuru vanofanira kutora trametinib 2 mg muromo kamwe chete zuva pamwe chete ne150 mg (mbiri 75 mg capsules) yedabrafenib kaviri pazuva. Zvichienderana nehuremu hwemuviri, varwere vevana vanofanirwa kutora trametinib uye dabrafenib pamiyero yakakodzera. Kune varwere vane huremu husingasviki 26 kg, hapana dhigirii yakatarwa.
View full prescribing information for Tafinlar and Mekinist
