ກອນກະດາຄົມ 2022: Dabrafenib (Tafinlar, Novartis) ແລະ trametinib (Mekinist, Novartis) ໄດ້ຮັບການເລັ່ງການອະນຸມັດຈາກອົງການອາຫານແລະຢາສໍາລັບການປິ່ນປົວຄົນເຈັບຜູ້ໃຫຍ່ແລະເດັກນ້ອຍທີ່ມີອາຍຸຫຼາຍກວ່າ 6 ປີທີ່ມີເນື້ອງອກແຂງທີ່ບໍ່ສາມາດແກ້ໄຂໄດ້ຫຼື metastatic ດ້ວຍການກາຍພັນຂອງ BRAF V600E ທີ່ມີຄວາມກ້າວຫນ້າຫຼັງຈາກໄດ້ຮັບການປິ່ນປົວດ້ວຍກ່ອນແລະບໍ່ມີທາງເລືອກການປິ່ນປົວທີ່ເຫມາະສົມອື່ນໆ. ສໍາລັບບຸກຄົນທີ່ເປັນມະເຮັງລໍາໄສ້ໃຫຍ່, dabrafenib ແລະ trametinib ບໍ່ໄດ້ຖືກແນະນໍາເນື່ອງຈາກຄວາມຕ້ານທານພາຍໃນທີ່ຮູ້ຈັກກັບ BRAF inhibition. ຄົນເຈັບທີ່ມີເນື້ອງອກແຂງທີ່ເປັນປະເພດ BRAF ບໍ່ໄດ້ຖືກແນະນໍາໃຫ້ກິນ 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 ໂຣກມະເຮັງຄໍລໍາ, 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 ກີໂລມາ 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.
ຄົນເຈັບຜູ້ໃຫຍ່ມີ pyrexia, ເມື່ອຍລ້າ, ປວດຮາກ, ຜື່ນ, ໜາວ ສັ່ນ, ເຈັບຫົວ, ເລືອດອອກ, ໄອ, ຮາກ, ທ້ອງຜູກ, ຖອກທ້ອງ, myalgia, arthralgia, ແລະ edoema ເລື້ອຍໆທີ່ສຸດ (20%).
ໃນບັນດາຄົນເຈັບເດັກນ້ອຍ, pyrexia, ຜື່ນ, ຮາກ, ອ່ອນເພຍ, ຜິວຫນັງແຫ້ງ, ໄອ, ຖອກທ້ອງ, dermatitis acneiform, ເຈັບຫົວ, ເຈັບກະເພາະອາຫານ, ປວດຮາກ, ຕົກເລືອດ, ທ້ອງຜູກ, ແລະ paronychia ແມ່ນຜົນຂ້າງຄຽງທີ່ພົບເລື້ອຍທີ່ສຸດ (20%).
ຄົນເຈັບຜູ້ໃຫຍ່ຄວນກິນຢາ trametinib 2 mg ປາກມື້ຫນຶ່ງພ້ອມກັບ 150 mg (ສອງແຄບຊູນ 75 mg) ຂອງ dabrafenib ສອງເທື່ອຕໍ່ມື້. ອີງຕາມນ້ໍາຫນັກຕົວ, ຄົນເຈັບເດັກນ້ອຍຄວນກິນ trametinib ແລະ dabrafenib ໃນປະລິມານທີ່ເຫມາະສົມ. ສໍາລັບຄົນເຈັບທີ່ມີນ້ໍາຫນັກຫນ້ອຍກວ່າ 26 ກິໂລ, ບໍ່ມີປະລິມານທີ່ກໍານົດໄວ້.
View full prescribing information for Tafinlar and Mekinist
