Kansarka xameetida ee daawada lala beegsaday, kansarka ganaca BRCA beddelka daroogada lala beegsaday olaparib (Olaparib, Liprot Lynparza) ayaa helay taageero khabiir FDA
Sababo la xiriira soo galitaanka xooggan iyo daawaynta xaddidan ee kansarka ganaca, wax daawayn horumarsan ah lama soo bandhigin dhawrkii sano ee la soo dhaafay, bukaannada qaba kansarka ganaca ee sare waxay si degdeg ah ugu baahan yihiin dawooyin iyo daweyn cusub oo waxtar leh. Caalamka, dhacdooyinka kudhaca jeermiska BRCA ee kudhaca kansarka ganaca waa 5-7%.
The targeted drug olapaly, which specifically targets BRCA mutations, has achieved excellent clinical data in the maintenance treatment of kansarka ganaca, which is enough to improve the current clinical treatment and help patients with advanced pancreatic cancer prolong their survival. Bishii Oktoobar 2018, Maamulka Cuntada iyo Dawooyinka ee Mareykanka (FDA) ayaa siiyay olapaly daaweynta daroogada agoonta ah ee kansarka ganaca.
Olaparib waxaa taageera guddiga khabiirada ee FDA ee daaweynta kansarka ganaca ee 'gBRCAm'
Diseembar 17, Maamulka Cuntada iyo Dawooyinka ee Mareykanka (FDA) Guddiga La-talinta Daawooyinka Oncology (ODAC) ayaa u codeeyay 7 ilaa 5 si ay ugu taliyaan ansixinta dawada lidka ku ah kansarka ee Lynparza (magaca sumadda Shiinaha: Liprot, magaca guud): Olaparib, olaparib), Sida daawaynta safka koowaad ee monotherapy, daaweynta bukaanada qaba kansarka qanjidhada dheef-shiid kiimikaadka kuwaas oo aan lahayn wax horumar ah ka dib markii la helo kiimoterabiga platina ee safka hore ugu yaraan 16 usbuuc oo xanbaarsan isu-beddelka BRCA ee jeermiska (gBRCAm).
Soo gudbinta sNDA waxay ku saleysan tahay natiijooyinka togan ee tijaabada POLO wajiga 3 ee lagu daabacay joornaalka New England Journal of Medicine oo lagu daabacay 2019 American Society of Clinical Oncology (ASCO) shir sanadeedka. Natiijooyinku waxay muujiyeen in muhiimadda tirakoobka iyo kiliinikada ee badbaadada-horumar la'aanta (PFS) si weyn loo hagaajiyay, taasoo hoos u dhigtay khatarta horumarka ama dhimashada 47%.
Olaparib wuxuu kudhowaad laba jibbaaray waqtiga badbaadada horusocod la'aanta bukaanada qaba kansarka ganaca faafa ee leh isbeddelada BRCA (3.8 vs 7.4 bilood).
Olapali has been approved by the US FDA for the treatment of ovarian and kansarka naasaha. Olaparib was approved by the US FDA in December 2014 to become the first PARP inhibitor approved globally, and has been approved in 65 countries around the world.
The good news is that Olapali has been approved for listing in China for the treatment of kansarka ugxansiduhu, and was included in the medical insurance catalog at the end of November this year. The price of drugs has dropped by about 60%. After the price reduction, it should be less than 10,000 yuan per box. According to 70% of medical insurance reimbursement, the price of each box of olapaly is almost 3,000 yuan, and the monthly cost of medication is 6,000 yuan.
Laba tilmaamood oo loogu talagalay Olapali
Bishii Ogosto 2018, Olapali waxaa loo oggolaaday in lagu qoro Shiinaha, wuxuu noqday daroogada ugu horreysa ee Shiinaha ee loogu talagalay kansarka ugxansidaha, loo isticmaalo daaweynta dayactirka kansarka ugxan-side ee soo noqnoqda ee platinum-ka (xaalad deggan ka dib daaweynta platinum, Ola Pali ayaa dib u dhigi karta waqtiga ku soo noqoshada).
Bishii Diseembar 5, 2019, China’s State Drug Administration has officially approved the use of olapa for first-line maintenance treatment of patients with BRCA-mutated advanced ovarian cancer. Benefiting from China’s vigorous support for pharmaceutical innovation and the accelerated advancement of clinically needed new drug approvals, olapaly became the first PARP inhibitor approved in China for first-line maintenance therapy of ovarian cancer.
Tilmaamaha Olapali ee ay ansixisay US FDA
Daaweynta dayactirka-safka hore ee kansarka ugxansidaha ee horumarsan oo leh isbeddelka BRCA
Daaweynta dayactirka bukaanada qaangaarka ah ee qaba waxyeelada ama looga shakisan yahay jeermiska waxyeellada leh ama isbadalka BRCA ee somatic (g BRCAm ama s BRCA m) ee bukaanka qaangaarka ah ee qaba kansarka ugxan-sidaha, kansarka ugxanta fallopian ama kansarka aasaasiga ee marinka dhameystiran ama jawaab ahaan. Xullo bukaanada loogu talagalay daaweynta iyadoo lagu saleynayo baaritaanka isku dhafan ee 'LYNPARZA' ee FDA ay ansaxisay.
Daaweynta dayactirka kansarka ugxan-side ee soo noqnoqda
Daaweynta dayactirka ee bukaanka qaangaarka ah ee qaba kansarka ugxan-yar ee epithelial, kansarka ugxanta, ama kansarka aasaasiga ah, bukaannadan waxay leeyihiin jawaab dhammaystiran ama qayb ah daaweynta kemotherabi ee ku saleysan platina.
Daaweynta boostada ee kansarka ugxansidaha ugxansidaha ee BRCA ee horumarsan
Daaweynta bukaanka qaangaarka ah ee qaba kansarka ugxansidaha ee leh waxyeelo ama looga shakiyo jeermis isku beddelka jeermiska BRCA (g BRCA m), waxay heleen 3 ama in ka badan daaweyn kiimiko ah oo safka hore ah. Xullo bukaanada loogu talagalay daaweynta iyadoo lagu saleynayo baaritaanka FDA ee LYNPARZA.
Isbedelka BRCA, daaweynta kansarka naasaha ee metastatic taban ee HER2
Daaweynta kansarka naasaha ee dheef-shiid kiimikaadka leh ee waxyeellada leh ama looga shakisan yahay jeermiska waxyeelada leh ee BRCA (g BRCA m), xuubka korriinka koritaanka bini'aadamka 2 (HER2) diidmo, kaas oo lagu daaweeyay daaweynta neoadjuvant, daaweynta adjuvant, ama kansarka metastatic. Bukaanka qaba kansarka naasaha ee hormoonka receptor (HR) togan waa inay marka hore helaan daawaynta endocrine, ama loo tixgeliyo inaysan ku habboonayn daawaynta endocrine. U dooro bukaanada daawaynta iyadoo lagu salaynayo ogaanshaha LYNPARZA ee FDA ogolaatay.
Olapali is a first-in-class, oral PARP inhibitor that utilizes defects in the DNA repair pathway to preferentially kill cancer cells. This mode of action gives Olapali the potential to treat a wide range of tumors with DNA repair defects. Currently approved for ovarian cancer and breast cancer, it is expected to be quickly approved for pancreatic cancer, and has achieved excellent results in the treatment of kansarka qanjirka 'prostate.
Mabda 'ahaan, bartilmaameedka ka-hortagayaasha PARP waa hiddo-wadaha BRCA, hadey tahay ansaxin kansarka ugxansidaha, kansarka naasaha, ama kansarka ganaca ee hadda helay taageerada khabiirada FDA, marka lagu daro daaweynta kansarka ugxan-sidaha soo noqnoqda, waxay ku habboon tahay Ola Bukaannada Parley waxay u baahan yihiin inay ogaadaan isbeddellada ku dhaca hidda-wadaha BRCA oo si indho la'aan ah uguma isticmaali karaan.
Sidaa darteed, aad bay muhiim u tahay in la helo warbixinnada baaritaanka hidda-socodka oo sax ah oo awood leh ka hor daaweynta. Kaliya haddii natiijada baadhista isku-beddelka hidda-wadaha ee BRCA ay sax yihiin ayaan rajayn karnaa inaan helno faa'iidooyinka badbaadada. Machadyada baaritaanka hidde-sidaha ee hadda suuqa ku jira aad ayey u kala duwan yihiin. Vicki waxay ku talinaysaa inaad tixgeliso isku halaynta hay'adaha baaritaanka hidda-socodka ee dhinacyada soo socda.
Marka hore, qalabka baarista qalabka - waa inuu ahaadaa mid sax ah, xogtuna waa sax!
Marka labaad, barnaamijka-keydka kombiyuutarka iyo awoodda khabiirku waa ubucda asaasiga ah!
Seddexaad, xakamaynta tayada-cabirka kooxda tijaabada ayaa go'aamisa saxnaanta natiijooyinka baaritaanka!
Tan afraad, shaybaarka-waa inuu helaa shahaadooyin qaran (caalami ah), CAP iyo CLIA labo shahaado ah!
Shanaad, aqoonsi rasmi ah-doorta baaritaanka hidda-sidaha ee la ansixiyay ee FDA ayaa ka ammaan badan.
