I-FDA yase-US namuhla igunyaze ukwethulwa ngokusemthethweni komuthi omusha we-AstraZeneca i-AZD9291! Igama lokuhweba negama elivamile le-AZD9291 libizwa ngokuthi i-Tagrisso noma i-Osimertinib. Lesi yisizukulwane sesithathu semithi ehloselwe i-TKI yokwelapha umdlavuza wamaphaphu ongewona omncane omncane, futhi ukufika kwawo kulethe izinzuzo ezinhle zokusinda ezigulini eziningi ezinomdlavuza wamaphaphu.
Ngesikhathi esifanayo, ochwepheshe be-Global Oncology Medical Network batshele iziguli ukuthi i-Tagrisso iqondiswe kuphela ezigulini ezinomdlavuza wamaphaphu ongewona omncane we-EGFR, futhi akuyona into yokuqala yokwelashwa. Kumele yelashwe ngokwezidingo zikadokotela. Iziguli akufanele ziphuphutheke ziye phesheya ukuze ziyokwelashwa.
Umuthi omusha we-AstraZeneca i-AZD9291 iyi-molecule encane yomlomo emele isikhumba sesithathu esimele ukukhula kwesici i-tyrosine kinase inhibitor (EGFR-TKI), engabhekana kanyekanye nokuguqulwa kofuzo kwe-EGFR (kuhlanganise 18, 19, 21) Ukuguqulwa) kanye ne-EGFR-TKI etholwe ukumelana (T790M) . I-AZD9291, njenge-WZ4002 ne-CO-1686, nayo isekelwe kumathambo e-pyrimidine, kodwa kunomehluko. I-AZD9291 iphinde ibe nobungozi obuthile kumaseli e-EGFR wild tumor.
Ngomhla ziyi-13 kuNovemba 2015, umuthi omusha womlomo i-Tagrisso (Osimertinib) washeshiswa yi-FDA ekwelapheni iziguli ezinomdlavuza wamaphaphu ongewona omncane omncane (NSCLC). I-Tagrisso isetshenziselwa ukwelapha umdlavuza wamaphaphu ongewona omncane ophethe i-epidermal growth factor receptor (EGFR) mutation (T790M) ethize, isifo esiba sibi ngemva kokuthola amanye ama-EGFR inhibitors.
NgokweNational Cancer Institute, umdlavuza wamaphaphu uyimbangela ehamba phambili yokufa komdlavuza e-United States. Kulinganiselwa ukuthi kube nezigameko zomdlavuza wamaphaphu ezintsha ezingu-221,200 kanye nezi-158,040 zokufa komdlavuza wamaphaphu e-United States ngo-2015. Umdlavuza wamaphaphu ongewona omncane (NSCLC) uwuhlobo oluvame kakhulu lomdlavuza wamaphaphu. Lapho amangqamuzana omdlavuza akha ezicutshini zamaphaphu, umdlavuza wamaphaphu ongewona omncane uyenzeka, futhi isakhi sofuzo se-EGFR siyiphrotheni ehilelekile ekukhuleni nasekusakazekeni kwamangqamuzana omdlavuza.
Uma ufuna ukubamba iqhaza esivivinyweni somtholampilo sesidakamizwa esisha i-AZD9291 noma uthole ukwelashwa kwezidakamizwa ezintsha, sicela ungene ku-Global Oncologist Network noma usishayele ku-4006667998.
URichard Pazdur, MD, umqondisi weSikhungo Sokuhlola Nokucwaninga Sezidakamizwa se-FDA, wathi: “Sinokuqonda okujulile ngesisekelo samangqamuzana omdlavuza wamaphaphu kanye nezimbangela zokumelana nomdlavuza wamaphaphu ekwelapheni kwangaphambilini. Lokhu kugunyazwa kuhle ezinguqukweni ezingazweli emuthini ze-EGFR T790M Ezigulini ezinomdlavuza wamaphaphu ongewona omncane zihlinzeka ngokwelashwa okusha. Ngokwenani elikhulu lezivivinyo zomtholampilo, i-Tagrisso inciphise kakhulu izimila zeziguli ezingaphezu kwesigamu. “
Namuhla, i-FDA iphinde yagunyaza ukuhlolwa kokuqala kokuxilonga ubuhlengikazi (i-coba seGFR mutation test v2) ukuthola ukuguqulwa kwe-EGFR okuhlosiwe ukumelana nomuthi. Inguqulo ye-batch entsha ehloliwe (V2) yengeze ukutholwa kokuguqulwa kwe-T790M ngokuhlolwa kokuguqulwa kwe-coba seGFR kwasekuqaleni (V1).
UDkt. Alberto Gutierrez, uMqondisi weHhovisi le-In Vitro Diagnostics and Radiological Health le-FDA Medical Devices and Radiation Health Centre, wathi “ukugunyaza ukuhlolwa kokuxilonga okuphephile nokuphumelelayo kwabahlengikazi kuseyintuthuko ebalulekile emkhakheni we-oncology. I-Coba seGFR mutation test v2 ingasetshenziswa ukuthola ukuguqulwa kofuzo kwe-EGFR kwenza ukwelashwa kusebenze kakhulu. “
Ukuphepha nokusebenza kahle kwe-Tagrisso kuqinisekiswe imibukiso emibili yezikhungo eziningi kanye nocwaningo lwengalo eyodwa. Isamba esingu-411 somdlavuza wamaphaphu okungewona amancanyana athuthukile anokuguqulwa kwe-EGFR T790M ayenethemba, futhi lezi ziguli zaba zimbi kakhulu ngemva kokuthola izivimbela ze-EGFR. Ngemva kokuthola i-Tagrisso, ama-57% eziguli ocwaningweni lokuqala kanye nama-61% eziguli ocwaningweni lwesibili azuze ukuqedwa okuphelele kwesimila noma ukuncipha kancane (okwaziwa ngokuthi izinga lokuphendula lenhloso).
Imiphumela evame kakhulu ye-Tagrisso isifo sohudo, isikhumba esomile, ukuqubuka, izifo zezinzipho, noma ububomvu. I-Tagrisso ingase futhi ibangele imiphumela emibi kakhulu, okuhlanganisa ukuvuvukala kwamaphaphu nokulimala kwenhliziyo. Kungase futhi kulimaze umbungu osakhulayo.
I-US Food and Drug Administration igunyaze i-AstraZeneca's Tagrisso njengendlela yokwelapha ephumelelayo, ebeka phambili ekubuyekezeni ukufaneleka kanye nokuqokwa kwesidakamizwa sezintandane. I-Breakthrough therapy icacisa ukuthi umuthi ogunyaziwe usetshenziselwa ukwelapha izifo ezinzima. Ngesikhathi sokufaka isicelo, kunobufakazi bokuqala bomtholampilo bokuthi lesi sidakamizwa singabonisa ukuthuthukiswa okuphawulekayo ekwelapheni okukhona. Ukugunyazwa okubalulekile kunikezwa, ikakhulukazi ngoba umuthi unokuphepha okubalulekile noma ukusebenza ngempumelelo ekwelapheni izifo ezimbi kakhulu. Izidakamizwa zezintandane zinikeza izikhuthazo ezifana nokukhululwa kwentela, ukuncishiswa kwezindleko zabasebenzisi, futhi zifanelekela ukuba yedwa emakethe ukuze zisize futhi zikhuthaze izidakamizwa ukuthi zenze izidakamizwa zezifo ezingavamile.
I-FDA igunyaze ukusetshenziswa kwe-Tagrisso ngemuva kwenqubo yokugunyaza esheshisiwe. Inqubo yokugunyaza esheshisiwe isetshenziselwa ukugunyaza izidakamizwa ezilapha izifo ezimbi kakhulu noma ezisongela ukuphila. Uma umuthi ungabikezela inzuzo yomtholampilo yeziguli, futhi ungathinta iphoyinti lokugcina. Le nqubo yokugunyaza ivumela iziguli ukuthi zithole imithi emisha enethuba lokumakethwa isinyathelo esisodwa ngaphambili ngesikhathi sokuhlolwa komtholampilo kwezinkampani ezenza imithi.
I-Tagrisso ithengiswa ngabakwa-AstraZeneca ezinze eWilmington, eDelaware. I-Coba seGFR yokuthola ukuguqulwa kwe-v2 ithengiswa yi-Roche Molecular Diagnostics e-Pleasanton, eCalifornia.
I-FDA iyisikhungo esigunyazwe uKhongolose wase-US, uHulumeni Wombuso, futhi izibandakanya nezempilo yomphakathi kanye nezinsizakalo zomphakathi ukuze kuqinisekiswe ukuphepha nokusebenza ngempumelelo kwezidakamizwa zabantu nezilwane, imigomo, imikhiqizo yebhayoloji, kanye nemishini yezokwelapha. I-ejensi futhi inesibopho sokuphepha kokuhlinzekwa kokudla, izimonyo, imikhiqizo yezempilo enomsoco, nemikhiqizo yemisebe ye-elekthronikhi e-United States futhi ilawula imikhiqizo kagwayi.
Izinkampani ezijwayelekile ezithaka imithi zizoyinikeza igama lekhodi ngesikhathi sesigaba socwaningo. I-AZD9291 igama layo lekhodi phakathi nesigaba socwaningo. Uma umuthi usugunyaziwe, kuzoba negama lokuhweba elicacile negama elejwayelekile. Igama lamanje lokuhweba negama elejwayelekile le-AZD9291 yi-Tagrisso ne-Osimertinib).
