Dawada kansarka sanbabada ee loo yaqaan "ALK-Positive Cancer Cancer" Ceritinib (LDK378) "- AASraw
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Certinib

 

    1. Ceritinib Waxaa Loo Ansixiyay Si Loogu Isticmaalo Midowga Yurub
    2. Sharaxaada Ceritinib
    3. Sidee Ceritinib Ugu Shaqeeysaa Daaweynta NSCLC?
    4. Sidee Ku Saabsan Isticmaalka Caafimaadka Ceritinib?
    5. Sidee loo kaydiyaa Ceritinib (LDK378)?
    6. Waa Maxay Waxyeelada Ceritinib?
    7. Waa maxay Faa'iidooyinka kale ee Ceritinib lagu muujiyey Daraasadaha?
    8. Ceritinib Ayaa Ansixisa Safka Hore ee FDA Ansixinta kansarka sanbabada ee ALK

 

Ceritinib Waxaa Loo Ansixiyay Isticmaalka EU

Ceritinib (CAS: 1032900-25-6) ayaa lagu muujiyey inay wax ku ool u tahay daaweynta bukaanada cudurkoodu ku sii socday muddadii ama waxyar ka dib daaweynta Crizotinib iyo kuwa hadda haysta fursado daaweyn oo aad u kooban, iyo sidoo kale bukaanno aan horay loo daweyn. Marka laga hadlayo amniga, dhibaatooyinka soo raaca Ceritinib guud ahaan waxay u muuqdeen kuwo la maareyn karo.

Wakaaladda dawooyinka Yurub ayaa sidaas darteed go'aansatay in dheefaha Ceritinib ay ka badan yihiin halisteeda waxayna ku talisay in loo oggolaado in loo isticmaalo EU.

Ceritinib markii hore waxaa la siiyay 'ogolaansho shuruud ah' maxaa yeelay waxaa jiray cadeymo dheeri ah oo ku saabsan daawada. Maaddaama shirkaddu ay bixisay macluumaadka dheeriga ah ee lagama maarmaanka u ah, oggolaanshaha waxaa laga beddelay mid shuruud ku jira oo loo oggolaaday.

Waa inaad xiise u yeelatid badeecadan, Aynu aqrino is-fahan badan oo ku saabsan Certinib:

 

Sharaxaada Ceritinib

Ceritinib waxaa loo isticmaalaa daaweynta dadka qaangaarka ah oo leh laf-dhabarka anaplastic lymphoma kinase (ALK) kansarka sanbabada ee aan yareyn (NSCLC) ka dib guuldaradii (labaad ee iska caabin ama dulqaad la'aan) daaweynta hore ee crizotinib. Qiyaastii 4% bukaannada qaba NSCLC waxay leeyihiin dib-u-habeyn koromosoom ah oo soo saarta hiddo-wadaha u dhexeeya EML4 (echinoderm microtubule-associated protein-like 4) iyo ALK (anaplastic lymphoma kinase), taas oo keenta waxqabad firfircoon oo kinase ah oo gacan ka geysta kansarka isla markaana u muuqda inuu wado astaamaha xun.

Ceritinib wuxuu sameeyaa saameynteeda daaweynta iyadoo la xakameynayo autophosphorylation-ka ee ALK, fosforyaalka ALK-dhexdhexaad ah ee borotiinka hoose ee calaamadaha STAT3, iyo faafitaanka unugyada kansarka ee ku tiirsan ALK. Daaweynta ka dib crizotinib (jiilka kowaad ee ALK inhibitor), burooyinka badankood waxay yeeshaan iska caabin daroogo sababtoo ah isbeddellada haraaga "albaabka" muhiimka ah ee enzme. Dhacdadani waxay horseedday horumarinta jiilka labaad ee ALK inhibitors sida ceritinib si looga adkaado caabbinta crizotinib. FDA ayaa ansixisay ceritinib bishii Abriil 2014 sababtoo ah heerka jawaab celinta aadka u sarreysa (56%) ee burooyinka u adkaysta crizotinib waxayna u qoondeysay xaalad daroogo agoon ah.

 

Sidee Ceritinib Ugu Shaqeeysaa Daaweynta NSCLC?

Ceritinib waa xulasho oo awood u leh ka-hortagga qanjirada 'lymphoma kinase' (ALK). Dhaqanka caadiga ah, Hawlaha ALK tallaabo muhiim ah u ah horumarka iyo shaqada unugyada habka neerfaha. Si kastaba ha noqotee, beddelka koromosoomyada iyo isugeynta waxay keenaysaa nooc ka mid ah kansarka 'ALK' kaas oo ku lug lahaa horumarka NSCLC. Ceritinib ayaa sidaas u dhaqmeysa si loo joojiyo enzyme-kan isbedelay iyo joojinta faafitaanka unugyada, ugu dambeyntiina joojiso horumarka kansarka Sababtoo ah ceritinib waxaa loo tixgeliyaa daaweynta kansarka la bartilmaameedsaday, baaritaanka FDA-ansaxiyay ayaa loo baahan yahay si loo go'aamiyo bukaanada u tartamaya ceritinib. Tijaabadan, oo ay soo saartay Roche, ayaa ah VENTANA ALK (D5F3) CDx Assay waxaana loo isticmaalaa in lagu aqoonsado bukaanada ALK-positive ee NSCLC ee ka faa’iideysan doona daaweynta ceritinib.

AASraw waa soo saaraha xirfadlaha ah ee Ceritinib.

Fadlan halkan guji si aad u hesho macluumaadka xigashada: Nala soo xiriir

 

Sidee Ku Saabsan Isticmaalka Caafimaadka Ceritinib?

Ceritinib (LDK378) waa dawo loo isticmaalo in lagu daaweeyo kansarka sanbabada ee unugyada aan yareyn ee ku faaftay qeybaha kale ee jirka waana anaplastic lymphoma kinase (ALK). Waxaa sidoo kale lagu baranayaa daaweynta noocyada kale ee kansarka. Ceritinib wuxuu xannibayaa borotiinka uu sameeyay hiddo-wadaha ALK. Joojinta borotiinkan waxay joojin kartaa koritaanka iyo faafitaanka unugyada kansarka. Ceritinib waa nooc ka mid ah tyrosine kinase inhibitor.

 

Certinib

 

Sidee loo kaydiyaa Ceritinib (LDK378)?

Ceritinib (LDK378) ku hay weelka uu soo galay, si adag u xir, oo ka fog carruurta. Ku keydi heerkulka qolka oo ka fog iftiinka, kuleylka badan iyo qoyaanka (ha ku jirin musqusha).

Daawooyinka aan loo baahnayn waa in lagu tuuraa siyaabo gaar ah si loo hubiyo in xayawaanka, carruurta, iyo dadka kaleba aysan cuni karin. Si kastaba ha noqotee, waa inaadan ku shubin Ceritinib (LDK378) musqusha. Taabadalkeed, sida ugufiican ee dawada looga takhalusi karaa waa iyada oo loo maro barnaamijka dib-u-celinta daawada. La hadal farmashiistahaaga ama la xiriir waaxda qashinka / dib u warshadaynta si aad wax uga ogaato barnaamijyada dib-u-celinta ee bulshadaada. Eeg Qashin Bixinta Amni ee FDA Bogga internetka ee dawooyinka wixii macluumaad dheeraad ah haddii aadan haysan barnaamijka dib-u-celinta.

Waxaa muhiim ah in daawada oo dhan la ilaaliyo oo ay gaaraan carruurta oo ay weheliyaan weelal badan (sida mashiinka kiniinka ee toddobaadlaha ah iyo kuwa dhibcaha kiniiniga, kiriimyada, dhejisyada, iyo neefsashada) ma aha ilmo u adkaysta caruurta yar yarna si fudud ayey u furi karaan. Si carruurta yar yar looga ilaaliyo sunta, marwalba xir albaabyada amniga iyo isla markaaba daawada meel nabadgelyo leh - waa mid kor u kaca oo ka baxsan aragtidooda iyo gaadho.

 

Waa Maxay Waxyeelada Ceritinib? 

Waxyaabaha muhiimka ah ee laga xasuusto dhibaatooyinka soo raaca 'ceritinib'

Dadka badankood ma dareemaan dhammaan dhibaatooyinka soo raaca ee taxan.

Effects Dhibaatooyinka soo raaca badanaa waa la saadaalin karaa marka loo eego bilowgooda iyo muddadooda.

Effects Dhibaatooyinka soo raaca badanaa waa la beddeli karaa waxayna bixi doonaan ka dib marka daaweyntu dhammaato.

Waxaa jira fursado badan oo kaa caawinaya yareynta ama ka hortagga dhibaatooyinka soo raaca.

Is Ma jiro xiriir u dhexeeya joogitaanka ama darnaanta dhibaatooyinka soo raaca iyo waxtarka daawada.

 

Waxyeellooyinka soo socdaa waa wax caadi ah (oo ku dhaca in ka badan 30%) bukaanada qaata ceritinib:

Arrhea Shuban

Em Hemoglobin wuu yaraaday

Kordhinta enzymes-ka beerka

Lallabbo

▪ Matag

Kordhinta creatinine

Ominal Calool xanuun

Daal

▪ Gulukooska oo kordhay

▪ Hoos u dhaca fosfateerka

Ite Rabitaanka cuntada oo yaraada

AASraw waa soo saaraha xirfadlaha ah ee Ceritinib.

Fadlan halkan guji si aad u hesho macluumaadka xigashada: Nala soo xiriir

 

Dhibaatooyinkan soo raaca waa waxyeelo aan caadi ahayn (oo ku dhacda qiyaastii 10-29%) bukaanada qaata ceritinib:

Calool fadhiga

▪ Lipase wuu kordhay

Disorder Cudurka hunguriga (Wadnaha oo gubta, dyspepsia, dysphagia)

▪ Rash

Ir Bilirubin (guud ahaan) wuu kordhay

Saameyn xun oo daran, laakiin aan caadi ahayn oo loo yaqaan 'ceritinib' waa oof wareenka (barar sambabaha). Markii waxyeelladani ay dhacday, waxaa badanaa la socday neefsashada oo adkaata qufac ama qandho heer-hoose ah oo u baahan isbitaal dhigid. Calaamaduhu waxay lamid noqon karaan astaamahaas kansarka sanbabada. La xiriir dhakhtarkaaga isla markiiba haddii aad leedahay wax calaamado cusub ah ama ka sii daraya.

Saameyn kale oo halis ah laakiin aan caadi ahayn oo ku jirta ceritinib waa isbeddelada EKG. Dhibaatooyinka oo dhan kuma qorna kor. Qaar dhif iyo naadir ah (oo ku dhaca wax ka yar 10% bukaannada) halkan kuma qorna. Si kastaba ha noqotee, waa inaad marwalba ogeysiisaa bixiyahaaga daryeelka caafimaadka haddii aad isku aragto astaamo aan caadi ahayn.

 

Certinib

 

Waa maxay Faa'iidooyinka kale ee Ceritinib lagu muujiyey Daraasadaha?

Laba ka mid ah daraasaddan, oo ku lug leh bukaanno 303 ah, daawada lama barbar dhigin daaweyn kale. Jawaabta daaweynta ayaa lagu qiimeeyay iyadoo la adeegsanayo baaritaanada jirka iyo shuruudaha la isku habeeyay ee loo isticmaalo burooyinka adag, iyadoo jawaabta oo dhameystiran ay tahay marka bukaanku uusan laheyn calaamadaha kansarka. Hal daraasad 56% bukaanada lasiiyay ceritinib (92 ee 163) waxaa tixgaliyay dhaqaatiirta daaweynta inay muujiyeen jawaab dhameystiran ama qeyb ah daawada. Celceliska celceliska jawaabta wuxuu ahaa 8.3 bilood. Daraasadda labaad, heerka jawaabta guud waxay ahayd 41% (57 ka mid ah 140 bukaan ah) celceliska celceliska jawaabtuna wuxuu ahaa 10.6 bilood.

Daraasadda saddexaad ee bukaannada 231, ceritinib waxaa lala barbardhigay daaweynta kiimikada ee caadiga ah (daawooyinka lagu daaweeyo kansarka). Natiijooyinka waxay muujiyeen in bukaanada la siiyay ceritinib ay noolaayeen celcelis ahaan 5.4 bilood iyada oo cudurkooda uusan ka sii darin (badbaado aan horusocod lahayn) marka la barbardhigo 1.6 bilood bukaanada la siiyay kimikalka caadiga ah.

Ceritinib ayaa sidoo kale la muujiyay inay wax ku ool u tahay daaweynta bukaanada aan horay loo daaweyn daraasad lagu sameeyay 376 bukaan ah. Bukaannada la siiyay ceritinib waxay noolaayeen celcelis ahaan 16.6 bilood iyadoon cudurkoodu ka sii darin marka loo barbardhigo 8.1 bilood ee bukaanada la siiyay kiimikada caadiga ah.

 

Ceritinib Ayaa Ansixisa Safka Hore ee FDA Ansixinta kansarka sanbabada ee ALK

FDA waxay ballaarisay oggolaanshaha ceritinib. Wakiilka ayaa hadda loo ansixiyay inuu yahay daweynta koowaad ee bukaanada qaba metastatic, ALK-positive, non-cell-cancer cancer. Maamulka Cuntada iyo Dawooyinka ee Mareykanka (FDA) ayaa balaariyay ogolaanshaha ceritinib. Wakiilka ayaa hadda loo ansixiyay inuu yahay daweynta koowaad ee bukaanada qaba metastatic, ALK-positive, non-small-cell cancer cancer (NSCLC).

Ceritinib (LDK378) waxaa horey loogu ansixiyay 2014 for ALK-metastatic metastatic NSCLC ee bukaanada horay u maray ama aan u dulqaadan karin crizotinib. Wakiilka waa xulasho afka ah oo la yiraahdo "ALK inhibitor", oo leh awood leh labaatan jeer tan crizotinib.

Tilmaanta cusub waxay ku saleysan tahay natiijooyinka tijaabada ASCEND-4, natiijooyinkeeda oo lagu daabacay bishii Janaayo ee sanadkan Lancet. Maxkamadaynta ayaa loo kala saaray 376 bukaan ah oo leh metastatic NSCLC oo leh dib-u-habeyn ALK ah ama ceritinib (189 bukaan ah) ama daaweynta loo yaqaan 'platinum-pemetrexed double therapy' (bukaanka 187).

Bar-dhammaadka aasaasiga ahi wuxuu ahaa badbaado-horusocod la'aan, ceritinib-na wuxuu ahaa mid waxtar badan. Badbaadada dhex-dhexaad la'aanta ah ee dhexdhexaad-ahaanta waxay ahayd 16.6 bilood oo ay lajirtay daroogada daraasadda, marka la barbardhigo 8.1 bilood oo gacanta gacanta ah, loogu talagalay heerka halista ee 0.55 (95% CI, 0.42-0.73; P <.0001).

Heerka jawaabta guud sidoo kale wuu ka fiicnaaday, 73% oo leh ceritinib iyo 27% oo kiimiko ah. Muddada jawaabta dhexdhexaadku waxay ahayd 23.9 bilood oo ay lasocoto ceritinib iyo 11.1 bilood oo ay lasocoto platinum / pemetrexed. Waqtigan xaadirka ah, xogta guud ee badbaadada ayaa ah mid aan bislaan. Ceritinib waxaa FDA u qoondeeyey magacaabista The Breakthrough Therapy, oo ay weheliso dib-u-eegis mudnaan leh oo ku saabsan daaweynta-safka koowaad ee bukaankaan.

Daraasada ASCEND-4 ayaa sidoo kale baartay heerarka jawaabta ee bukaanada qaba dhaawacyada nidaamka neerfaha ee la qiyaasi karo. Qiyaasta jawaab celinta intracranial waxay ahayd 57% oo la socota ceritinib, marka la barbardhigo 22% oo leh daaweynta kemotherabi.

Dhacdooyinka halista ah ee daran (AEs) waxay ka dhaceen 38% bukaanada lagu daaweeyay ceritinib, iyo AEs oo horseedaya joojinta daawada ayaa ka dhacday 12%. Joojinta qiyaasta ee AEs ayaa lagu arkay 77% bukaannada ceritinib, iyo 66% dhimista qiyaasta loo baahan yahay. AE-yada ugu caansan ee daawada ku jira ASCEND-4 waxaa ka mid ah shuban, lallabbo, matag, daal, iyo calool xanuun. "Ansixinta maanta waxay u taagan tahay tallaabada xigta ee horumarinta Zykadia oo ah ikhtiyaar daaweyn ah oo loogu talagalay ALK-positive metastatic NSCLC, keenista daawadan muhiimka ah ee bukaanka bukaanka halkaasoo baahi loo qabo wali," ayuu yiri agaasimaha guud ee Novartis Oncology Bruno Strigini, war-saxaafadeed.

AASraw waa soo saaraha xirfadlaha ah ee Ceritinib.

Fadlan halkan guji si aad u hesho macluumaadka xigashada: Nala soo xiriir

 

Tixraaca

[1] Mano H: EML4-ALK oncogene: bartilmaameedka darawalka koritaanka lagama maarmaanka u ah kansarka dadka. Proc Jpn Acad Ser B Phys Biol Sci. 2015; 91 (5): 193-201. doi: 10.2183 / pjab.91.193. [PubMed: 25971657].

[2] Soria JC, Tan DS, Chiari R, Wu YL, Paz-Ares L, Wolf J, iyo al. (Maarso 2017). "Khadka koowaad ee ceritinib iyo kansarka ku saleysan platinum ee daaweynta kiimikada ee horumarsan ee ALK-dib-u-habeyn lagu sameeyay kansarka sanbabada ee unugyada yar-yar (ASCEND-4): daraasad aan kala sooc lahayn, sumad furan, wajiga 3-aad". Lancet. 389 (10072): 917–929.

[3] Xuan C, Gunduz V. "NSCLC MARKET - Saadaalinta Daroogada Caalamiga ah & Falanqaynta Suuqa illaa 2025". Horumarinta Daroogada & Gaarsiinta. Maya Nofeembar – Diseembar 2016.

[4] "FDA waxay u ansixineysaa Ceritinib kansarka sanbabada ee loo yaqaan 'ALK-Positive Loss Cancer'. Medscape. Abriil 29, 2014.

[5] Au TH, Cavalieri CC, Stenehjem DD Ceritinib: Hordhac u ah farmashiistayaasha // Dhaqanka farmashiyaha Oncology. - 2017. - Vol. 23 (8). - P. 611 (doi: 10.1177 / 1078155216672315).

[6] Nishio M, Murakami H, Horiike A, Takahashi T, Hirai F, Suenaga N, Tajima T, Tokushige K, Ishii M, Boral A, Robson M, Seto T: Wejiga 378aad ee Daraasada Ceritinib (LDK2015) ee bukaanada Japan oo leh Horumar, Anaplastic Lymphoma Kinase-Dib-u-habeyn loogu sameeyay Kansarka Sambabka ee Unugyada Yar Yar ama Burooyinka Kale. J Thorac Oncol. 10 Jul; 7 (1058): 66-10.1097. doi: 0000000000000566 / JTO.26020125. [PubMed: XNUMX].

[7] Galkin AV, Melnick JS, Kim S, Hood TL, Li N, Li L, Xia G, Steensma R, Chopiuk G, Jiang J, Wan Y, Ding P, Liu Y, Sun F, Schultz PG, Gray NS, Warmuth M : Aqoonsiga NVP-TAE684, awood, xulasho, iyo waxtar waxtar u leh NPM-ALK. Proc Natl Acad Sci US A. 2007 Jan 2; 104 (1): 270-5. Epub 2006 Dec 21. [PubMed: 17185414].

[8] Marsilje TH, Pei W, Chen B, Lu W, Uno T, Jin Y, Jiang T, Kim S, Li N, Warmuth M, Sarkisova Y, Sun F, Steffy A, Pferdekamper AC, Li AG, Joseph SB, Kim Y , Liu B, Tuntland T, Cui X, Gray NS, Steensma R, Wan Y, Jiang J, Chopiuk G, Li J, Gordon WP, Richmond W, Johnson K, Chang J, Groessl T, He YQ, Phimister A, Aycinena A, Lee CC, Bursulaya B, Karanewsky DS, Seidel HM, Harris JL, Michellys PY: Isku xidhka, xidhiidhada qaab-dhismeedka, iyo ku-noolaanshaha wax-ku-oolka ee hal-abuurka xoogga leh iyo xulashada 'anaplastic lymphoma kinase (ALK) inhibitor 5-chloro-N2- (2-isopropoxy-5-methyl-4- (piperidin-4-yl) phenyl) -N4- (2- (isopropylsulf onyl) phenyl) pyrimidine-2,4-diamine (LDK378) oo hadda kujira wajiga 1 iyo kiliinikada 2 tijaabooyin. J Med Chem. 2013 Jul 25; 56 (14): 5675-90. doi: 10.1021 / jm400402q. Epub 2013 Jun 26. [PubMed: 23742252].

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