ALK-Ingantaccen Kwayar Cutar Cancer "Ceritinib (LDK378)" - AASraw
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Ceritinib

 

    1. An Amince Ceritinib Don Amfani da EU
    2. Bayanin Ceritinib
    3. Ta yaya Ceritinib ke aiki don Kula da NSCLC?
    4. Yaya Game da Amfani da Maganin Ceritinib?
    5. Ta yaya Don Adana Ceritinib (LDK378)?
    6. Menene Gurbin Ceritinib?
    7. Waɗanne Fa'idodin Ceritinib Ne Aka Nuna A Nazarin?
    8. Ceritinib ya sami Yarda da Farko na Farko na FDA don Ciwon Cutar Lantarki na ALK

 

An Amince Ceritinib Don Amfani da EU

Ceritinib (CAS: 1032900-25-6) an nuna yana da tasiri wajen kula da marasa lafiya waɗanda cutar ta ci gaba a lokacin ko jim kaɗan bayan jiyya da crizotinib kuma waɗanda a halin yanzu suna da iyakance zaɓuɓɓukan magani, da marasa lafiya waɗanda ba a yi musu magani ba a da. Game da aminci, illolin da ke tattare da Ceritinib gabaɗaya sun zama abin sarrafawa.

Don haka Hukumar Kula da Magunguna ta Turai ta yanke shawarar cewa fa'idodin Ceritinib sun fi haɗarinsa haɗari kuma ta ba da shawarar cewa a amince da amfani da shi a cikin EU.

Da farko an ba Ceritinib 'yarda da sharaɗi' saboda akwai ƙarin shaidun da zai zo game da maganin. Kamar yadda kamfanin ya kawo ƙarin bayanin da ake buƙata, an sauya izini daga sharaɗi zuwa cikakken yarda.

Dole ne ku kasance da sha'awar wannan samfurin, Bari mu karanta ƙarin haɓaka game da Ceritinib:

 

Bayanin Ceritinib

Ana amfani da Ceritinib don maganin manya tare da maganin kaifin kifin (lykhoma kinase) (ALK) cututtukan daji na kansa marasa kansar (NSCLC) bin gazawa (na biyu zuwa juriya ko rashin haƙuri) na maganin crizotinib na farko. Kimanin kashi 4% na marasa lafiya tare da NSCLC suna da tsarin sake fasalin chromosomal wanda ke haifar da kwayar halitta tsakanin EML4 (echinoderm microtubule hade da furotin-kamar 4) da ALK (anaplastic lymphoma kinase), wanda ke haifar da aikin kinase wanda ke ba da gudummawa ga carcinogenesis kuma da alama yana tuki mummunan mummunan abu.

Ceritinib yana aiki da tasirin warkewa ta hanyar hana autophosphorylation na ALK, phosphorylation mai matsakaicin matsakaici na ALK na ƙarancin siginar mai alamar STAT3, da kuma yaɗuwar ƙwayoyin cutar kansa masu dogaro da ALK. Bayan bin magani tare da crizotinib (mai hana shigar ALK na ƙarni na farko), yawancin ciwace-ciwacen suna haifar da juriya na ƙwayoyi saboda maye gurbi a cikin maɓallin "mai tsaron ƙofa" mai mahimmanci na enzyme. Wannan lamarin ya haifar da ci gaban ƙwararrun masu hana ALK na ƙarni na biyu kamar su ceritinib don shawo kan juriya crizotinib. Hukumar ta FDA ta amince da ceritinib a cikin watan Afrilu na 2014 saboda tsananin saurin mayar da martani (56%) zuwa ga ciwace-ciwacen da ke da tsayayyar crizotinib kuma an tsara shi da matsayin magungunan marayu.

 

Ta yaya Ceritinib ke aiki don Kula da NSCLC?

Ceritinib shine mai zaɓaɓɓen mai hana ƙarfi na maganin ƙwayar lymphoma kinase (ALK). A cikin ilimin lissafi na al'ada, Ayyukan ALK a matsayin babban mahimmin ci gaba a cikin ci gaba da aiki na ƙwayoyin cuta. Koyaya, canzawar chromosomal da fusion suna haifar da wani nau'ikan oncogenic na ALK wanda ke cikin ci gaban NSCLC. Ceritinib don haka yayi aiki don hana wannan maye gurbin enzyme da dakatar da yaduwar kwayar halitta, a karshe dakatar da ci gaba da cutar kansa.Domin ana daukar ceritinib a matsayin maganin cutar kansa da aka yi niyya, ana buƙatar gwajin da aka amince da FDA don tantance waɗanne marasa lafiya ne candidatesan takarar ceritinib. Wannan gwajin, wanda Roche ya haɓaka, shine VENTANA ALK (D5F3) CDx Assay kuma ana amfani dashi don gano marasa lafiya na NSCLC masu ƙarfin ALK waɗanda zasu amfana daga maganin ceritinib.

AASraw ƙwararren masani ne na Ceritinib.

Da fatan za a danna nan don bayanin zance: Saduwa da mu

 

Yaya Game da Amfani da Maganin Ceritinib?

Ceritinib (LDK378) magani ne da ake amfani da shi don magance ƙananan ƙwayoyin cuta na huhu wanda ya bazu zuwa wasu sassan jiki kuma yana da ƙwayar lymphoma kinase (ALK) mai kyau. Har ila yau, ana nazarin shi a cikin maganin wasu nau'o'in ciwon daji. Ceritinib yana toshe sunadaran da kwayar ALK tayi. Toshe wannan furotin na iya dakatar da ci gaba da yaduwar ƙwayoyin kansa. Ceritinib wani nau'in mai hana cin hanci ne na tyrosine kinase.

 

Ceritinib

 

Ta yaya Don Adana Ceritinib (LDK378)?

A ajiye Ceritinib (LDK378) a cikin akwatin da ya shigo, a rufe sosai, kuma daga inda yara zasu isa. Ajiye shi a zafin jiki na ɗaki kuma nesa da haske, yawan zafin rana da danshi (ba cikin gidan wanka ba).

Ya kamata a zubar da magunguna marasa magani ta hanyoyi na musamman don tabbatar da cewa dabbobin gida, yara, da sauran mutane ba za su iya cinye su ba. Koyaya, bai kamata ku zubar da Ceritinib (LDK378) a bayan gida ba. Madadin haka, hanya mafi kyau don zubar da maganinku shine ta hanyar shirin dawo da magani. Yi magana da likitan ka ko ka tuntuɓi sashen shara / sake amfani da datti na gida don koyo game da shirye-shiryen dawo da martabar ku a yankin ku. Duba Abincin lafiya na FDA na Magungunan yanar gizon Magunguna don ƙarin bayani idan ba ku da damar shirin dawo da ku.

Yana da muhimmanci a kiyaye dukkan maganin da ba a gani da kuma isa ga yara kamar kwantena da yawa (irin su jariri da kullun mako daya da wadanda ke da idanu, creams, patches, and inhalers) ba su da yarinya kuma yara masu iya buɗe su sauƙi. Don kare yaran yara daga guba, kulle kullun lafiya kuma sanya wuri a cikin wuri mai aminci - wanda ke sama da tafi da kuma daga idanunsu kuma ya isa.

 

Menene Gurbin Ceritinib? 

Muhimmin abubuwa don tunawa game da illolin ceritinib:

▪ Mafi yawan mutane basu fuskanci duk illolin da aka lissafa ba.

Effects Tasirin sakamako sau da yawa ana iya fa'idarsa dangane da farkonsu da tsawonsu.

Effects Illolin lalacewar kusan akasari ana juyawa kuma zasu tafi bayan an kammala jiyya.

Akwai zaɓuɓɓuka da yawa don taimakawa rage ko hana illa.

Babu wata dangantaka tsakanin kasancewar ko tsananin tasirin tasiri da tasirin maganin.

 

Wadannan sakamako masu illa na yau da kullun (suna faruwa a cikin fiye da 30%) ga marasa lafiya da ke shan ceritinib:

Arrhea Gudawa

Em Hemoglobin ya ragu

Inara yawan enzymes na hanta

▪ Ciwan mara

▪ Amai

Inara yawan halitta

Pain Ciwon ciki

Gajiya

Lu Glucose ya karu

Rage cikin fosfat

Ite Rage sha'awa

AASraw ƙwararren masani ne na Ceritinib.

Da fatan za a danna nan don bayanin zance: Saduwa da mu

 

Wadannan cututtukan ba su da illa sosai (wanda ke faruwa a kusan 10-29%) na marasa lafiya da ke karɓar ceritinib:

▪ Maƙarƙashiya

Lipase ya karu

Cutar cututtukan zuciya (Zafin zuciya, dyspepsia, dysphagia)

▪ Rash

Ir Bilirubin (duka) ya karu

Babban sakamako, amma sanannen sakamako na ceritinib shine ciwon huhu (kumburin huhu). Lokacin da wannan tasirin ya faru, yakan kasance tare da wahalar numfashi tare da tari ko ƙarancin zazzabi mai buƙatar asibiti. Kwayar cutar na iya zama daidai da waɗancan alamun cutar daga cutar huhu. Tuntuɓi mai ba da sabis na kiwon lafiya kai tsaye idan kana da wasu sababbin alamomi ko munana.

Wani mawuyacin sakamako mai mahimmanci amma ba sananne bane na ceritinib shine canje-canje na EKG. Ba duk larurar illa ce aka lissafa a sama ba. Wasu waɗanda ba safai ba (waɗanda ke faruwa a ƙasa da 10% na marasa lafiya) ba a lissafa su a nan ba. Koyaya, koyaushe yakamata ku sanar da mai ba ku kiwon lafiya idan kun fuskanci wasu alamomi na ban mamaki.

 

Ceritinib

 

Waɗanne Fa'idodin Ceritinib Ne Aka Nuna A Nazarin?

A cikin waɗannan nazarin guda biyu, waɗanda suka shafi marasa lafiya 303, ba a kwatanta maganin da wani magani. An yi amfani da martani ga magani ta hanyar amfani da sikanin jiki da daidaitattun ka'idodi da ake amfani da su don ciwace-ciwacen daji, tare da cikakken amsa yayin da mai haƙuri ba shi da sauran alamun cutar kansa. A cikin binciken daya 56% na marasa lafiya da aka ba ceritinib (92 na 163) an yi la'akari da su ta likitocin da ke kula da su don nuna cikakke ko juzu'in magani. Matsakaicin tsawon amsawa ya kasance watanni 8.3. A cikin binciken na biyu, yawan amsawar ya kasance 41% (57 na marasa lafiya 140) kuma matsakaicin tsawon amsawa ya kasance watanni 10.6.

A cikin bincike na uku a cikin marasa lafiya 231, an kwatanta ceritinib da daidaitaccen ilimin kimiya (magunguna don magance kansar). Sakamako ya nuna cewa marasa lafiyar da aka baiwa ceritinib sun rayu na kimanin watanni 5.4 ba tare da cutar ta ta'azzara ba (rayuwa mara ci gaba) idan aka kwatanta da watanni 1.6 a cikin marasa lafiya da aka ba da ilimin kimiya na musamman.

Ceritinib an kuma nuna yana da tasiri wajen kula da marassa lafiyar da ba a ba su magani ba a baya a cikin binciken da aka yi wa marasa lafiya 376. Marasa lafiya da aka ba wa ceritinib sun rayu na kimanin watanni 16.6 ba tare da cutar ta ci gaba da taɓarɓarewa ba idan aka kwatanta da watanni 8.1 a cikin marasa lafiya da aka ba da ilimin kimiya na musamman.

 

Ceritinib ya sami Yarda da Farko na Farko na FDA don Ciwon Cutar Lantarki na ALK

FDA ta faɗaɗa yarda don ceritinib. Yanzu an amince da wakili a matsayin maganin layin farko a marasa lafiya da ke fama da cutar metastatic, ALK-tabbatacce, ƙananan ƙwayar ƙwayar huhu. Hukumar Abinci da Magunguna ta Amurka (FDA) ta faɗaɗa yarda ga ceritinib. Yanzu an amince da wakili a matsayin magani na farko a cikin marasa lafiya masu fama da cutar metastatic, ALK-tabbatacce, ƙananan ƙananan ƙwayoyin cuta na huhu (NSCLC).

Ceritinib (LDK378) an riga an amince da shi a cikin 2014 don ALK-tabbataccen metastatic NSCLC a cikin marasa lafiya waɗanda suka ci gaba ko suka yi haƙuri ga crizotinib. Wakilin shine mai zaɓin baka na ALK, tare da ƙarfin sau ashirin na na crizotinib.

Sabon nuni ya dogara ne da sakamakon gwajin ASCEND-4, wanda aka buga sakamakonsa a watan Janairun wannan shekarar a Lancet. Gwajin ya rarraba marasa lafiya 376 tare da NSCLC mai haɗari tare da sake fasalin ALK zuwa ga ko dai ceritinib (marasa lafiya 189) ko kuma maganin wariyar ninki biyu na platinum-pemetrexed (marasa lafiya 187).

Matsayi na farko shine rayuwa ba tare da cigaba ba, kuma ceritinib yafi tasiri. Rayuwa mara matsakaiciyar ci gaba ba ta wuce watanni 16.6 tare da maganin nazarin ba, idan aka kwatanta da watanni 8.1 a cikin jiyyar cutar sankara, don yanayin haɗari na 0.55 (95% CI, 0.42-0.73; P <.0001).

Matsakaicin jimlar amsawa ya kasance mafi kyau, a 73% tare da ceritinib da 27% tare da chemotherapy. Matsakaicin lokacin amsawa ya kasance watanni 23.9 tare da ceritinib da watanni 11.1 tare da platinum / pemetrexed. A wannan gaba, bayanan rayuwar gabaɗaya bai balaga ba. Hukumar ta FDA ta ba Ceritinib kyautar Nasihun Faruwa, tare da fifikon dubawa na maganin layin farko a cikin wannan haƙuri.

Nazarin na ASCEND-4 ya kuma bincika ƙimar amsawa a cikin marasa lafiya tare da raunin tsarin juyayi na tsakiya. Adadin amsawar intracranial ya kasance 57% tare da ceritinib, idan aka kwatanta da 22% tare da chemotherapy.

Mugayen abubuwan da suka faru (AEs) sun faru a cikin 38% na marasa lafiya da aka bi da su tare da ceritinib, kuma AEs da ke haifar da dakatar da maganin ya faru a cikin 12%. An katse katsewar kwayoyi saboda AE a cikin 77% na marasa lafiya na ceritinib, kuma 66% ana buƙatar ragin kashi. Mafi yawan AEs tare da magani a cikin ASCEND-4 sun haɗa da gudawa, tashin zuciya, amai, gajiya, da ciwon ciki. "Amincewar yau tana wakiltar mataki na gaba a ci gaban Zykadia a matsayin zaɓin magani don ALK-tabbatacce metastatic NSCLC, yana kawo wannan mahimmancin magani ga marasa lafiyar marasa lafiya inda buƙata ta kasance har yanzu," in ji Shugaba na Novartis Oncology Bruno Strigini, a cikin wata sanarwa.

AASraw ƙwararren masani ne na Ceritinib.

Da fatan za a danna nan don bayanin zance: Saduwa da mu

 

reference

[1] Mano H: EML4-ALK oncogene: niyya ga mahimmin ci gaban haɓaka cikin cutar kansa. Sanarwar 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, et al. (Maris 2017). "Layin farko na ceritinib da ke hade da sinadarin platinum a cikin ci gaban ALK-wanda aka sake fasalin cutar sankarar huhu da ke karama (ASCEND-4): bazuwar, lakabin budewa, nazarin lokaci na 3". Lancet. 389 (10072): 917-929.

[3] Xuan C, Gunduz V. "NSCLC MARKET - Tattaunawar Magungunan Duniya & Binciken Kasuwanci zuwa 2025". Ci gaban Magunguna & Isarwa. A'a Nuwamba-Disamba 2016.

[4] "FDA Ta Amince da Ceritinib don ALK-Ingantaccen Ciwon Huhu". Madubi. Afrilu 29, 2014.

[5] Au TH, Cavalieri CC, Stenehjem DD Ceritinib: A share fage na masu harhada magunguna // Aikin likitan kan 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: Lokacin Nazarin Nazarin Ceritinib (LDK378) a cikin Jafananci Marasa lafiya tare da Ci gaba, Anamplastic Lymphoma Kinase-An sake Canza Canjin Nonananan Cellananan Cellwayar Cutar Fari ko Sauran Tumurai. J Thorac Oncol. 2015 Jul; 10 (7): 1058-66. Doi: 10.1097 / JTO.0000000000000566. [PubMed: 26020125].

[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 : Gano NVP-TAE684, mai ƙarfi, zaɓaɓɓe, kuma mai hana ingancin NPM-ALK. Kamfanin 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: Kira, alaƙar aiki-da aiki, kuma a cikin ingancin ingancin labari mai tasiri da zaɓaɓɓen magungunan ƙwayoyin cuta na lymphoma kinase (ALK) mai hanawa 5-chloro-N2- (2-isopropoxy-5-methyl-4- (piperidin-4-yl) phenyl) -N4- (2- (isopropylsulf onyl) phenyl) pyrimidine-2,4-diamine (LDK378) a halin yanzu a cikin lokaci na 1 da na 2 na asibiti gwaji. J Med Chem. 2013 Jul 25; 56 (14): 5675-90. Doi: 10.1021 / jm400402q. Epub 2013 Jun 26. [PubMed: 23742252].

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