FDA ta Amurka a yau ta amince da ƙaddamar da sabon magani na AstraZeneca a hukumance AZD9291! Sunan ciniki da sunan gama gari na AZD9291 ana kiransa Tagrisso ko Osimertinib. Wannan shine ƙarni na uku na magungunan TKI da aka yi niyya don maganin ci gaba da cutar kansar huhu mara ƙanƙanta, kuma zuwan sa ya kawo fa'idodin rayuwa mai kyau ga ƙarin masu cutar kansar huhu.
A lokaci guda kuma, masana daga Cibiyar Kula da Lafiya ta Duniya ta Duniya, sun shaida wa marasa lafiya cewa Tagrisso an yi niyya ne kawai ga marasa lafiya da ke fama da cutar kansar huhu mara ƙanƙanta EGFR, kuma ba shine zaɓi na farko na magani ba. Dole ne a bi da shi bisa ga buƙatun likita. Kada majinyata su fita waje a makance don neman magani.
Sabon magani na AstraZeneca AZD9291 shine ƙaramin ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar cuta ta uku wakilin fata girma factor tyrosine kinase inhibitor (EGFR-TKI), wanda zai iya magance lokaci guda tare da maye gurbi na EGFR (ciki har da 18, 19, 21) maye gurbi) da EGFR-TKI sun sami juriya (T790M) . AZD9291, kamar WZ4002 da CO-1686, kuma sun dogara ne akan kwarangwal na pyrimidine, amma akwai bambance-bambance. AZD9291 kuma yana da ƙayyadaddun kisa ga ƙwayoyin cutar daji na EGFR.
A ranar 13 ga Nuwamba, 2015, FDA ta haɓaka sabon magani na baka Tagrisso (Osimertinib) don kula da marasa lafiya da ke fama da ciwon huhu na huhu (NSCLC). Ana amfani da Tagrisso don magance ciwon daji na huhu wanda ba ƙananan ƙwayoyin cuta ba wanda ke ɗauke da takamaiman maye gurbi na haɓakar haɓakar epidermal (EGFR) (T790M), cutar da ke tsananta bayan karɓar wasu masu hana EGFR.
A cewar Cibiyar Ciwon daji ta Kasa, ciwon huhu shine babban dalilin mutuwar ciwon daji a Amurka. An kiyasta cewa akwai sabbin cututtukan daji na huhu 221,200 da kuma mutuwar cutar kansar huhu guda 158,040 a Amurka a cikin 2015. Ciwon daji na huhu mara karami (NSCLC) shine nau'in kansar huhu da aka fi sani. Lokacin da kwayoyin cutar kansa suka fito a cikin nama na huhu, ciwon huhu mara ƙananan ƙwayar cuta yana faruwa, kuma kwayar EGFR shine furotin da ke cikin girma da yaduwar kwayoyin cutar kansa.
Idan kuna son shiga cikin gwajin asibiti na sabon magani AZD9291 ko karɓar sabon magani, da fatan za a shiga Cibiyar Sadarwar Oncologist ta Duniya ko a kira mu a 4006667998.
Richard Pazdur, MD, darektan Cibiyar Nazarin Magunguna da Magunguna ta FDA, ya ce: "Muna da zurfin fahimtar tushen kwayoyin cutar kansar huhu da kuma abubuwan da ke haifar da ciwon huhu na huhu ga jiyya na baya. Wannan amincewa yana da inganci ga maye gurbi na EGFR T790M mai jure wa magani Na marasa lafiya da ciwon huhu marasa ƙananan ƙwayoyin cuta suna ba da sabon magani. Bisa ga babban adadin gwaje-gwaje na asibiti, Tagrisso ya rage yawan ciwace-ciwacen ƙwayoyi fiye da rabin marasa lafiya. "
A yau, FDA ta kuma amince da gwajin gwajin jinya na farko (gwajin maye gurbin coba seGFR v2) don gano maye gurbi na EGFR da aka yi niyya. Sabuwar sigar batch da aka gwada (V2) ta ƙara gano maye gurbin T790M ta ainihin gwajin maye gurbin coba seGFR (V1).
Dokta Alberto Gutierrez, Daraktan Ofishin In Vitro Diagnostics da Lafiyar Radiyo na Na'urorin Kiwon Lafiya na FDA da Cibiyar Lafiya ta Radiation, ya ce "amincewa da amintattun gwaje-gwajen gwajin jinya da magunguna har yanzu wani muhimmin ci gaba ne a fagen ilimin cututtukan daji. Ana iya amfani da gwajin maye gurbin Coba seGFR v2 don gano maye gurbi na EGFR na sa magani ya fi tasiri. "
An tabbatar da aminci da ingancin Tagrisso ta hanyar zanga-zangar tsakiya guda biyu da binciken hannu guda. Jimillar cutar kansar huhun huhu guda 411 da ba ƙananan ƙwayoyin cuta ba tare da maye gurbin EGFR T790M sun tabbata, kuma waɗannan marasa lafiya duk sun yi muni bayan sun karɓi EGFR blockers. Bayan karbar Tagrisso, 57% na marasa lafiya a cikin binciken farko da 61% na marasa lafiya a cikin binciken na biyu sun sami cikakkiyar kawar da ƙwayar cuta ko raguwa (wanda aka sani da ƙimar amsawar haƙiƙa).
Mafi yawan illolin Tagrisso sune gudawa, bushewar fata, rashes, cututtukan farce, ko ja. Tagrisso na iya haifar da mummunar illa, gami da kumburin huhu da lalacewar zuciya. Hakanan yana iya cutar da tayin da ke tasowa.
Hukumar Abinci da Magunguna ta Amurka ta amince da AstraZeneca's Tagrisso a matsayin ingantaccen magani, yana ba da fifiko ga yin la'akari da cancanta da tantance magungunan marayu. Ƙwararrun Ƙwararrun Ƙwararru ya ƙayyade cewa ana amfani da miyagun ƙwayoyi da aka ba da izini don magance cututtuka masu tsanani. A lokacin aikace-aikacen, akwai shaidar asibiti na farko cewa wannan magani na iya nuna ci gaba mai mahimmanci a cikin jiyya na yanzu. An ba da izinin fifiko, musamman saboda maganin yana da aminci mai mahimmanci ko tasiri a cikin maganin cututtuka masu tsanani. Magungunan marayu suna ba da abubuwan ƙarfafawa kamar sassaucin haraji, rage kuɗin mai amfani, kuma sun cancanci keɓance kasuwa don taimakawa da ƙarfafa magunguna don haɓaka magunguna don cututtukan da ba kasafai ba.
FDA ta amince da aikace-aikacen Tagrisso bayan ingantaccen tsarin amincewa. Ana amfani da tsarin amincewa da gaggawa don amincewa da magungunan da ke kula da cututtuka masu tsanani ko masu barazana ga rayuwa. Idan miyagun ƙwayoyi na iya hango hasashen fa'idar asibiti na marasa lafiya, kuma zai iya shafar ƙarshen ƙarshen maye. Wannan tsari na yarda ya ba marasa lafiya damar samun sababbin magungunan da ke da damar da za a sayar da su mataki daya a baya yayin gwajin asibiti na kamfanonin harhada magunguna.
AstraZeneca ne ke siyar da Tagrisso a Wilmington, Delaware. Coba seGFR gano maye gurbin v2 ana siyar da shi ta Roche Molecular Diagnostics a Pleasanton, California.
FDA wata hukuma ce da Majalisar Wakilan Amurka, Gwamnatin Tarayya ta ba da izini, kuma tana yin ayyukan kiwon lafiyar jama'a da ayyukan jama'a don tabbatar da aminci da ingancin magungunan ɗan adam da na dabbobi, alluran rigakafi, samfuran halitta, da na'urorin likitanci. Har ila yau, hukumar tana da alhakin kare lafiyar kayan abinci, kayan kwalliya, kayan kiwon lafiya masu gina jiki, da na'urorin lantarki na lantarki a Amurka tare da daidaita kayan sigari.
Kamfanonin harhada magunguna na gabaɗaya za su ba shi sunan lamba yayin lokacin bincike. AZD9291 shine sunan lambar sa yayin lokacin bincike. Da zarar an amince da miyagun ƙwayoyi, za a sami sunan kasuwanci bayyananne da sunan gama gari. Sunan kasuwanci na yanzu da sunan gama gari na AZD9291 sune Tagrisso da Osimertinib).
