Yuli 2022: Dabrafenib (Tafinlar, Novartis) da kuma Trametinib (Mekinist, Novartis) An sami karɓuwa da sauri daga Hukumar Abinci da Magunguna don kula da tsofaffi da marasa lafiya na yara waɗanda suka girmi shekaru 6 tare da ciwace-ciwacen da ba za a iya jurewa ba ko metastatic tare da maye gurbin BRAF V600E waɗanda suka ci gaba bayan sun karɓi magani na farko kuma ba su da sauran zaɓuɓɓukan magani masu dacewa. Ga mutanen da ke da ciwon daji na launi, dabrafenib da trametinib ba a ba da shawarar ba saboda sanannen juriya na ciki ga hana BRAF. Marasa lafiya tare da ciwace-ciwacen daji waɗanda ke da nau'in daji na BRAF ba a ba da shawarar ɗaukar dabrafenib ba.
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 maganin ciwon daji, 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.
Manya marasa lafiya suna da pyrexia, gajiya, tashin zuciya, rash, sanyi, ciwon kai, zubar jini, tari, amai, maƙarƙashiya, zawo, myalgia, arthralgia, da edoema akai-akai (20%).
Daga cikin marasa lafiya na yara, pyrexia, kurji, amai, gajiya, bushewar fata, tari, gudawa, dermatitis kuraje, ciwon kai, ciwon ciki, tashin zuciya, zubar jini, maƙarƙashiya, da paronychia sune mafi yawan lokuta (20%).
Ya kamata manya marasa lafiya su sha trametinib 2 MG da baki sau ɗaya a rana tare da 150 MG (biyu 75 capsules) na dabrafenib sau biyu a rana. Dangane da nauyin jiki, marasa lafiya na yara ya kamata su dauki trametinib da dabrafenib a matakan da suka dace. Ga marasa lafiya waɗanda ba su da nauyin kilogiram 26, babu wani adadin da aka saita.
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