ሐምሌ 2022: ዳብራፊኒብ (ታፊንላር፣ ኖቫርቲስ) ና ትራሜቲኒብ (ሜኪኒስት ፣ ኖቫርቲስ) ከ6 አመት በላይ የሆናቸው የጎልማሶች እና የህፃናት ህመምተኞች ከ BRAF V600E ሚውቴሽን ጋር ያልተለቀቁ ወይም የሜታስታቲክ ጠንካራ እጢዎች ቀድመው ህክምና ካገኙ በኋላ እድገት ያደረጉ እና ሌላ ተስማሚ የህክምና አማራጮች ለሌሉት ከምግብ እና መድሀኒት አስተዳደር የተፋጠነ ይሁንታ አግኝቷል። የኮሎሬክታል ካንሰር ላለባቸው ግለሰቦች ዳብራፊኒብ እና ትራሜቲኒብ ለ BRAF መከልከል በሚታወቀው ውስጣዊ ተቃውሞ ምክንያት አይመከሩም። የ BRAF የዱር ዓይነት የሆኑ ጠንካራ እጢዎች ያለባቸው ታካሚዎች ዳብራፊኒብ እንዲወስዱ አይመከሩም.
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 ሜላኖማ 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 ካንሰር, 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.
የአዋቂዎች ታካሚዎች ፒሬክሲያ፣ ድካም፣ ማቅለሽለሽ፣ ሽፍታ፣ ብርድ ብርድ ማለት፣ ራስ ምታት፣ ደም መፍሰስ፣ ሳል፣ ማስታወክ፣ የሆድ ድርቀት፣ ተቅማጥ፣ ማያልጂያ፣ አርትራልጂያ እና ኢዶማ (20%) ነበራቸው።
ከህጻናት ህመምተኞች መካከል ፒሬክሲያ ፣ ሽፍታ ፣ ማስታወክ ፣ ድካም ፣ ደረቅ ቆዳ ፣ ሳል ፣ ተቅማጥ ፣ የቆዳ በሽታ አክኔይፎርም ፣ ራስ ምታት ፣ የሆድ ህመም ፣ ማቅለሽለሽ ፣ የደም መፍሰስ ፣ የሆድ ድርቀት እና ፓሮኒቺያ በጣም በተደጋጋሚ የጎንዮሽ ጉዳቶች (20%) ናቸው።
የአዋቂዎች ታካሚዎች በቀን ሁለት ጊዜ ትራሜቲኒብ 2 mg በአፍ ከ150 mg (ሁለት 75 mg capsules) ዳብራፊኒብ ጋር በቀን ሁለት ጊዜ መውሰድ አለባቸው። በሰውነት ክብደት ላይ በመመስረት, የሕፃናት ታካሚዎች ትራሜቲኒብ እና ዳብራፊኒብ በተገቢው መጠን መውሰድ አለባቸው. ክብደታቸው ከ 26 ኪሎ ግራም በታች ለሆኑ ታካሚዎች የተወሰነ መጠን የለም.
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