Chikafu neDrug Administration yakabvumidza repotrectinib (Augtyro, Bristol-Myers Squibb Kambani) yenzvimbo yepamusoro kana metastatic ROS1-positive isiri diki cell cancer cancer (NSCLC) muna Mbudzi 15, 2023.
Iyi mvumo yeFDA ndiyo yekutanga kusanganisa varwere vane ROS1-positive NSCLC vakamborapwa neROS1 tyrosine kinase inhibitor (TKI), pamwe nevanhu vasina kumborapwa TKI.
Mvumo yakapiwa ichitevera TRIDENT-1 kliniki yekuedza (NCT03093116), chidzidzo chepasi rose chinosanganisira nzvimbo dzakawanda, neruoko rumwe chete, rakazaruka-label design, uye mapoka akasiyana-siyana evarwere ane ROS1-positive munharaunda inofambira mberi kana metastatic NSCLC. Kubudirira kwakaongororwa mu71 ROS1 TKI-naïve varwere vakanga vambopfuura 1 yapfuura mutsara weplatinum-based chemotherapy uye / kana. immunotherapy, uye muvarwere makumi mashanu nevatanhatu vakange vagamuchira 56 yapfuura ROS1 TKI vasina preplatinum-based chemotherapy kana immunotherapy.
Iwo ekutanga efficacy matanho aive akazara mhinduro mwero (ORR) uye nguva yekupindura (DOR) yakavakirwa paRECIST v1.1 sezvakaongororwa neasingasaruri central wongororo. Yakasimbiswa Objective Response Rate (ORR) yaiva 79% (95% CI: 68, 88) muboka revarwere vakanga vasina kurapwa neROS1 TKI kare, uye 38% (95% CI: 25, 52) muvarwere vane akanga ambogamuchira kurapwa neROS1 inhibitor. Nguva yepakati yekupindura yaiva 34.1 mwedzi (95% CI: 25.6, isingaenzaniswi) uye 14.8 mwedzi (95% CI: 7.6, isingaenzaniswi) mumapoka maviri, maererano. Kucherechedzwa kwakaitwa mumaronda ehuropi evarwere vane quantifiable central nervous system metastases, pamwe chete mune vanhu vane kushorwa shanduko mushure me tyrosine kinase inhibitor therapy.
Mhinduro dzakaipa dzinowanzoitika, dzinoitika mune dzinopfuura 20% dzezviitiko, dzaive dzungu, dysgeusia, peripheral neuropathy, kuvimbiswa, dyspnea, ataxia, kuneta, matambudziko ekuziva, uye kushaya simba kwetsandanyama.
Iyo yakakurudzirwa repotrectinib dosage ndeye 160 mg inotorwa nemuromo kamwe pazuva, nekudya kana pasina, kwemazuva gumi nemana. Mushure mezvo, iyo dosage inofanira kuwedzerwa kusvika ku14 mg inotorwa kaviri pazuva kusvikira kufambira mberi kwechirwere kana kusagadzikana kwehuturu.
kenza
Lutetium Lu 177 dotatate inotenderwa neUSFDA kune vana vane makore gumi nemaviri zvichikwira neGEP-NETS.
Lutetium Lu 177 dotatate, kurapwa kwepasi, ichangobva kugamuchira mvumo kubva kuUS Food and Drug Administration (FDA) yevarwere vevana, zvichiratidza chiitiko chakakosha muvana oncology. Mvumo iyi inomiririra chiedza chetariro kuvana vari kurwisana neuroendocrine tumors (NETs), isingawanzowanikwi asi inonetsa yegomarara iro rinowanzoratidza kuti rinoshingirira pakurapa kwakajairika.
Alysha Mendossa
Dai 11, 2024
