Iulii 2022: Dabrafenib (Tafinlar, Novartis) et trametinib (Mekinist, Novartis) Acceleratus approbatio recepta a Cibus et medicamentis Administrationis ad curationem aegrorum adultorum et pediatricorum antiquiorem quam 6 annorum cum tumoribus solidis irresectibilibus vel metastaticis cum mutatione BRAF V600E, qui progressi sunt, acceptis prius therapiis et nullas alias optiones curationes idoneas habent. Singuli enim cum cancro colorectali, dabrafenib et trametinib non commendantur ob repugnantiam intrinsecam notae inhibitionis BRAF. Aegris cum solidis tumoribus qui sunt BRAF silvestres species non commendantur ut dabrafenib capiatur.
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 colorectal cancer, 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.
Aegroti adulti pyrexia, languor, nausea, temeritas, infrigidatio, capitis, sanguinis, tussis, vomitus, constipatio, diarrhoea, myalgia, arthralgia, edoema frequentius sunt (20%).
Inter aegros pediatricos, pyrexia, temeraria, vomitus, lassitudo, cutis arida, tussis, diarrhoea, dermatitis acneiformes, capitis, dolor stomachi, nausea, haemorrhagia, constipatio, et paronychia frequentissimi effectus sunt (20%).
Aegri adulti viva voce trametinib 2 mg semel in die cum 150 mg (capsulae 75 mg duo) bis in die dabrafenib. Ex pondere corporis, aegros pediatricis trametinib et dabrafenib congruis dosibus sumere debet. Aegris qui minus quam 26 kg pendunt, nulla dosis statuta est.
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