Julayi 2022: I-Dabrafenib (Tafinlar, Novartis) futhi i-trametinib (i-Mekinist, i-Novartis) ithole ukugunyazwa okusheshisiwe okuvela kwabeFood and Drug Administration yokwelapha iziguli ezikhulile nezezingane ezindala kuneminyaka engu-6 ubudala ezinamathumba aqinile angenakuhlanzwa noma ama-metastatic ngokuguqulwa kwe-BRAF V600E eziye zathuthuka ngemva kokuthola ukwelashwa kwangaphambili futhi azinazo ezinye izindlela zokwelapha ezifanele. Kubantu abanomdlavuza we-colorectal, i-dabrafenib ne-trametinib akunconywa ngenxa yokwaziwa kwangaphakathi ukumelana nokuvinjelwa kwe-BRAF. Iziguli ezinezimila eziqinile eziwuhlobo lwasendle lwe-BRAF azinconywa ukuthi zithathe i-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 umdlavuza 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 ama-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.
Iziguli zabantu abadala zazine-pyrexia, ukukhathala, isicanucanu, ukuqubuka, ukugodola, ikhanda elibuhlungu, ukopha, ukukhwehlela, ukuhlanza, ukuqunjelwa, isifo sohudo, i-myalgia, i-arthralgia, kanye ne-edoma kaningi (20%).
Ezigulini zezingane, i-pyrexia, ukuqubuka, ukuhlanza, ukukhathala, isikhumba esomile, ukukhwehlela, isifo sohudo, i-dermatitis acneiform, ikhanda elibuhlungu, ubuhlungu besisu, isicanucanu, ukopha, ukuqunjelwa, kanye ne-paronychia kwakuyimiphumela emibi kakhulu (20%).
Iziguli zabantu abadala kufanele zithathe i-trametinib 2 mg ngomlomo kanye ngosuku kanye no-150 mg (amaphilisi amabili angu-75 mg) we-dabrafenib kabili ngosuku. Ngokusekelwe esisindweni somzimba, iziguli zezingane kufanele zithathe i-trametinib ne-dabrafenib ngemithamo efanelekile. Ezigulini ezinesisindo esingaphansi kwama-26 kg, awekho umthamo obekiwe.
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