Iyo US FDA nhasi yatendera kuvhurwa zviri pamutemo kweAstraZeneca mushonga mutsva AZD9291! Zita rekutengesa uye zita rinozivikanwa reAZD9291 rinonzi Tagrisso kana Osimertinib. Ichi ndicho chizvarwa chechitatu cheTKI yakanangana nemishonga yekurapwa kwepamusoro isiri-diki kenza yemapapu, uye kuuya kwayo kwakaunza mabhenefiti ekupona kune vamwe varwere vekenza yemapapu.
Panguva imwecheteyo, nyanzvi kubva kuGlobal Oncology Medical Network dzakaudza varwere kuti Tagrisso inongonangwa kune varwere vasina diki-diki kenza yemapapu EGFR mutations, uye haisiriyo sarudzo yekutanga kurapwa. Inofanira kurapwa maererano nezvinodiwa nachiremba. Varwere havafanire kuenda kunze kwenyika kunorapwa.
Mushonga mutsva weAstraZeneca AZD9291 ndeyemumuromo diki molecule yechitatu inomiririra ganda kukura factor tyrosine kinase inhibitor (EGFR-TKI), iyo inogona panguva imwe chete kubata neEGFR gene mutations (kusanganisira 18, 19, 21) Mutation) uye EGFR-TKI yakawana kuramba (T790M) . AZD9291, seWZ4002 uye CO-1686, inobvawo pane pyrimidine skeleton, asi pane kusiyana. AZD9291 zvakare ine imwe hutsinye kune EGFR mhuka dzesango masero.
Musi waMbudzi 13, 2015, mushonga mutsva wemukanwa Tagrisso (Osimertinib) wakakwidziridzwa neFDA pakurapa varwere vane advanced non-diki cell lung cancer (NSCLC). Tagrisso inoshandiswa kurapa isiri-diki kenza yemapapu yemapapu inotakura chaiyo epidermal growth factor receptor (EGFR) mutation (T790M), chirwere chinowedzera mushure mekugamuchira mamwe EGFR inhibitors.
Maererano neNational Cancer Institute, kenza yemapapu ndiyo inonyanya kukonzera kufa kwegomarara muUnited States. Inofungidzirwa kuti pane 221,200 yekenza yemapapu matsva uye 158,040 kufa kwekenza yemapapu muUnited States muna 2015. Non-small cell lung cancer (NSCLC) ndiyo inowanzozivikanwa yekenza yemapapu. Kana masero emukenza akaumbwa mumapapu emapapu, isiri-diki kenza yemapapu inoitika, uye EGFR gene ipuroteni inobatanidzwa mukukura nekupararira kwekenza masero.
Kana uchida kutora chikamu mukuedza kwekiriniki kwemushonga mutsva AZD9291 kana kugamuchira kurapwa kutsva kwezvinodhaka, ndapota pindai paGlobal Oncologist Network kana kutifonera panhamba dzinoti 4006667998.
Richard Pazdur, MD, director weFDA's Center for Drug Evaluation and Research, akati: “Tine nzwisiso yakadzama yehwaro hwemamorekuru ekenza yemapapu uye zvikonzero zvekuramba kenza yemapapu pakurapwa kwakapfuura. Mvumo iyi yakanaka kune isingarapike nemishonga EGFR T790M kuchinja kwevarwere vane isiri-diki kenza yemapapu inopa mushonga mutsva. Zvinoenderana nehuwandu hukuru hwemakiriniki ekuyedzwa, Tagrisso yakaderedza zvakanyanya mapundu einopfuura hafu yevarwere. “
Nhasi, iyo FDA yakabvumidzawo yekutanga bvunzo yekuongorora mukoti (coba seGFR mutation bvunzo v2) kuona yakanangwa kurwisa zvinodhaka EGFR shanduko. Iyo nyowani batch vhezheni yakaedzwa (V2) yakawedzera kuwanikwa kweiyo T790M shanduko neiyo yekutanga coba seGFR mutation bvunzo (V1).
Dr. Alberto Gutierrez, Mutungamiriri weHofisi yeIn Vitro Diagnostics uye Radiological Health yeFDA Medical Devices uye Radiation Health Center, akati "kubvumidza kuongororwa kwakachengeteka uye kunobudirira kwekuongorora kuongororwa kwevanamukoti nemishonga kuchiri kufambira mberi kwakakosha mumunda weoncology. Coba seGFR mutation test v2 inogona kushandiswa kuona EGFR Genetic mutations inoita kuti kurapwa kushande. “
Kuchengetedzeka uye kushanda kwaTagrisso kwakasimbiswa nekuratidzira kwepakati-zhinji uye kutsvagisa kweruoko rumwe. Huwandu hunosvika mazana mana negumi nerimwe emhando dzekenza dzemapapu dzisiri diki neEGFR T411M mutation dzaive dzakanaka, uye varwere ava vese vakawedzera zvakanyanya mushure mekugamuchira EGFR blockers. Mushure mekugamuchira Tagrisso, 790% yevarwere muchidzidzo chekutanga uye 57% yevarwere muchidzidzo chechipiri vakawana kubviswa kwakazara kwebundu kana shrinkage chidimbu (inozivikanwa seyero yekupindura kwechinangwa).
Migumisiro yakajairika yeTagrisso manyoka, ganda rakaoma, mapundu, zvirwere zvezvipikiri, kana kutsvuka. Tagrisso inogonawo kukonzera zvakakomba mhedzisiro, kusanganisira kuzvimba kwemapapu uye kukuvara kwemoyo. Inogonawo kukanganisa mwana ari kukura.
Iyo US Chikafu neDrug Administration yakabvumidza AstraZeneca's Tagrisso senzira yekurapa, ichipa pamberi pekuongorora kukodzera uye zita remishonga yenherera. Breakthrough therapy inotsanangura kuti mushonga unobvumirwa unoshandiswa kurapa zvirwere zvakakomba. Panguva yekushandiswa, pane humbowo hwekutanga hwekiriniki hwekuti mushonga uyu unogona kuratidza kuvandudzwa kwakakosha mukurapa kuripo. Mvumo yakakosha inopihwa, kunyanya nekuti mushonga une chengetedzo yakakosha kana kushanda mukurapa kwezvirwere zvakakomba. Mishonga yenherera inopa kurudziro yakadai sekurerutsa mutero, kuderedza mari yevashandisi, uye inokodzera kutengwa pamusika kubatsira nekukurudzira mishonga kugadzira mishonga yezvirwere zvisingawanzo.
FDA yakabvumidza kushandiswa kweTagrisso mushure mekukurumidza kubvumidza maitiro. Iyo yekukurumidza kubvumidza maitiro inoshandiswa kubvumidza zvinodhaka zvinorapa zvakakomba kana zvinouraya zvirwere. Kana mushonga uchigona kufanotaura kubatsirwa kwekiriniki yevarwere, uye unogona kukanganisa surrogate endpoint. Iyi nzira yekubvumidza inobvumira varwere kuwana mishonga mitsva ine mukana wekutengeswa nhanho imwe kare panguva yekuedzwa kwekiriniki yemakambani emishonga.
Tagrisso inotengeswa neAstraZeneca inogara muWilmington, Delaware. Coba seGFR mutation yekuona v2 inotengeswa neRoche Molecular Diagnostics muPleasanton, California.
Iyo FDA isangano rakatenderwa neUS Congress, iyo Federal Government, uye inobata hutano hweveruzhinji neruzhinji masevhisi kuti ive nechokwadi chekuchengetedza uye kushanda kwemishonga yevanhu neyemhuka, majekiseni, zvigadzirwa zvebiological, uye michina yekurapa. Iyo agency inewo basa rekuchengetedza kwechikafu, zvizoro, zvigadzirwa zvehutano zvinovaka muviri, uye zvigadzirwa zvemagetsi radiation muUnited States uye inodzora zvigadzirwa zvefodya.
General makambani emishonga anozopa iyo kodhi zita panguva yekutsvagisa chikamu. AZD9291 izita rayo rekodhi panguva yekutsvagisa chikamu. Kana mushonga wacho watenderwa, pachava nezita rekutengesa rakajeka uye zita regeneric. Irizvino zita rekutengesa uye zita regeneric reAZD9291 ndiTagrisso neOsimertinib).
