Hana ʻo AASraw i nā pauka NMN a me NRC i ka nui!

Ceritinib

 

    1. Ua ʻae ʻia ʻo Ceritinib No ka hoʻohana ʻana ma EU
    2. Hōʻike Ceritinib
    3. Pehea e hana ai ʻo Ceritinib no ka mālama ʻana iā NSCLC?
    4. Pehea e pili ai i ka Ceritinib Medical Medical?
    5. Pehea e mālama ai iā Ceritinib (LDK378)?
    6. He aha nā hopena ʻaoʻao o Ceritinib?
    7. He aha nā pono ʻē aʻe o Ceritinib i hōʻike ʻia i loko o nā noiʻi?
    8. Loaʻa ʻo Ceritinib i ka ʻĀpono o ka lālani FDA no ka maʻi maʻi maʻi maʻi ALK-Positive Lung

 

Ua ʻae ʻia ʻo Ceritinib no ka hoʻohana ʻana ma EU

Ceritinib (CAS: 1032900-25-6) i hōʻike ʻia he maikaʻi i ka mālama ʻana i nā mea maʻi i holo ka maʻi i ka wā a ma hope paha o ka lapaʻau ʻana me crizotinib a ʻo nā mea i kaupalena ʻia nā koho lapaʻau ʻana, a me nā mea maʻi i mālama ʻole ʻia ma mua. E pili ana i ka palekana, ua hiki ke mālama ʻia nā hopena maikaʻi ʻole me Ceritinib.

No laila ua hoʻoholo ka European Medicines Agency e ʻoi aku ka nui o nā pono o Ceritinib ma mua o kāna mau pilikia a koi ʻia e ʻae ʻia no ka hoʻohana ʻana i ka EU.

Ua hāʻawi ʻia ʻo Ceritinib i ka 'ʻae ʻae ʻia' no ka mea ʻoi aku ka nui o nā hōʻike e pili ana i ka lāʻau. E like me ka hoʻolako ʻana o ka ʻoihana i ka ʻike hou aku e pono ai, ua hoʻololi ʻia ka ʻae mai ke kūlana a i ka ʻae piha.

Pono ʻoe e hoihoi e pili ana i kēia huahana, E heluhelu hou infromation e pili ana Ceritinib:

 

Hōʻike Ceritinib

Hoʻohana ʻia ʻo Ceritinib no ka mālama ʻana i nā mākua me ka anaplastic lymphoma kinase (ALK) -positive metastatic maʻi ʻaʻai liʻiliʻi liʻiliʻi liʻiliʻi ʻole (NSCLC) ma hope o ke kūleʻa (lua i ke kūʻē ʻana a i ʻole intolerance) o ka crizotinib therapy mua. Ma kahi o 4% o nā mea maʻi me NSCLC i kahi hoʻoponopono hou chromosomal e hana i kahi fusion fusion ma waena o EML4 (echinoderm microtubule-pili protein-e like me 4) a me ALK (anaplastic lymphoma kinase), nā hopena i ka hana kinase Constutive e hāʻawi i ka carcinogenesis a me ka mea e hoʻokele ka phenotype malignant.

Hana ʻo Ceritinib i kāna hopena therapeutic e ka pāpā ʻana i ka autophosphorylation o ALK, ALK-mediated phosphorylation o ka pūlima hōʻailona STAT3 i lalo, a me ka hoʻonui ʻana o nā hunaola maʻi kūpoko ALK. Ma hope o ka mālama ʻana me crizotinib (kahi hanauna ALK hanauna mua), hoʻomohala ka hapanui o nā tumors i ke kūpaʻa lāʻau ma muli o ka hoʻololi ʻana i nā koena "kiaʻi puka" kī o ka enzyme. ʻO kēia hanana i alakaʻi ʻia i ka hoʻomohala ʻana i nā mea hanauna ALK hanauna ʻelua e like me ceritinib e lanakila i ke kūʻē ʻana o crizotinib. Ua ʻae ka FDA i ka ceritinib i ʻApelila 2014 ma muli o ke kuhi pane pane kiʻekiʻe (56%) i nā tumors kūʻē crizotinib a ua kuhikuhi ʻia me ke kūlana lāʻau makua ʻole.

 

Pehea e hana ai ʻo Ceritinib no ka mālama ʻana iā NSCLC?

ʻO Ceritinib kahi mea koho a me ka mea pāpā i ka anaplastic lymphoma kinase (ALK). I ka physiology maʻamau, Nā hana a ALK ma ke ʻano he kī nui i ka hoʻomohala ʻana a me ka hana o nā pūnaewele nūhou. Eia nō naʻe, hāʻawi ka translocation chromosomal a me ka fusion i kahi ʻano oncogenic o ALK i hoʻopili ʻia i ka holomua o NSCLC. Hana ʻo Ceritinib e kāohi i kēia enzyme mutated a hoʻōki i ka hoʻonui ʻana o ka cell, ke kū nei i ka holomua o ka maʻi ʻaʻa. No ka mea ua manaʻo ʻia ʻo ceritinib kahi maʻi maʻi ʻaʻai i makemake ʻia, koi ʻia kahi hōʻike i ʻae ʻia e ka FDA e hoʻoholo i nā mea maʻi i moho no ceritinib. ʻO kēia hōʻike, hoʻomohala ʻia e Roche, ʻo ia ka VENTANA ALK (D5F3) CDx Assay a hoʻohana ʻia e ʻike i nā mea maʻi ALK-maikaʻi NSCLC e pōmaikaʻi i ka mālama ceritinib.

ʻO AASraw ka mea hana ʻoihana Ceritinib.

E ʻoluʻolu e kaomi ma aneʻi no ka ʻike ʻōlelo. pākuʻiHana iā mākou

 

Pehea e pili ai i ka Ceritinib Medical Medical?

ʻO Ceritinib (LDK378) kahi lāʻau i hoʻohana ʻia e mālama ai i ka maʻi ʻaʻai liʻiliʻi liʻiliʻi i pāhola ʻia i nā ʻāpana ʻē aʻe o ke kino a he anaplastic lymphoma kinase (ALK) maikaʻi. Ke aʻo ʻia nei nō hoʻi i ka mālama ʻana i nā ʻano maʻi ʻaʻai ʻē aʻe. Ua ālai ʻo Ceritinib i ka protein i hana ʻia e ka ʻohana ALK. Hiki i ka pale ʻana i kēia protein ke hoʻopau i ka ulu a hoʻolaha ʻana o nā hunaola maʻi ʻaʻai. ʻO Ceritinib kahi ʻano o ka inhibitor tyrosine kinase.

 

Ceritinib

 

Pehea e mālama ai iā Ceritinib (LDK378)?

E mālama iā Ceritinib (LDK378) i loko o ka pahu i komo mai ai, pani paʻa loa ʻia, a me kahi hiki ʻole i nā kamaliʻi. E mālama iā ia i ka mahana wela o ka lumi a mamao aku mai ka mālamalama, ka wela a me ka makū nui (ʻaʻole i ka lua

Pono e hoʻolei ʻia nā lāʻau i koi ʻole ʻia i nā ala kūikawā e hōʻoia i ka hiki ʻole i nā holoholona, ​​nā keiki, a me nā poʻe ʻē aʻe ke hoʻopau iā lākou. Eia nō naʻe, ʻaʻole pono ʻoe e pīpī iā Ceritinib (LDK378) i lalo o ka lua. Akā, ʻo ke ala ʻoi loa e hoʻolilo i kāu lāʻau i loko o kahi papahana hoʻihoʻi lāʻau. E kamaʻilio me kāu kauka lāʻau a kāhea paha i kāu ʻōpala a me nā hana hoʻopōʻaiapuni kūloko e aʻo e pili ana i nā papahana hoʻihoʻi i kou kaiāulu. E ʻike i ka Ka hoʻolei palekana ʻana o FDA o ka pūnaewele Medicines no ka ʻike hou aku inā ʻaʻole ʻoe e komo i kahi papahana hoʻihoʻi.

He mea nui ka mālamaʻana i nā lāʻau a pau mai kaʻikeʻana a hiki i nā keiki e like me nā pahu (e like me nā pilina o ka pule hebedoma a me ka mea no nā maka o ka maka, ka'ōpū, nā pāpale, a me nā mea inu)ʻaʻole hiki ke kū'ē i ka'ōpiopio a hiki i nā keiki'ōpiopio ke wehe iā lākou. No ka paleʻana i nā keiki liʻiliʻi mai ka lāʻauʻawaʻawa, e hoʻopaʻa mau i nā piko palekana a kau koke i ka lāʻau i kahi wahi palekana - kahi eʻoi aku ana i waho a ma waho aku o ko lākou mau maka a hiki.

 

He aha nā hopena ʻaoʻao o Ceritinib? 

Nā mea nui e hoʻomanaʻo e pili ana i nā hopena ʻaoʻao o ceritinib:

▪ ʻAʻole ʻike ka hapa nui o nā poʻe i nā hopena ʻaoʻao āpau i helu ʻia.

▪ Kuhi pinepine ʻia nā hopena ʻaoʻao e pili ana i ka hoʻomaka a me ka lōʻihi.

▪ ʻAneʻane hiki ke hoʻohuli i nā hopena ʻaoʻao a e hele aku ma hope o ka pau ʻana o ka mālama ʻana.

▪ Nui a hewahewa nā koho e kōkua i ka hōʻemi a pale ʻana paha i nā hopena ʻaoʻao.

▪ ʻAʻohe pilina ma waena o ke kū a me ke koʻikoʻi o nā hopena a me ka hopena o ka lāʻau.

 

ʻO nā hopena ʻē aʻe i maʻa mau (e ʻike ʻia ma mua o 30%) no nā mea maʻi e lawe ana i ka ceritinib:

▪ Pohā

▪ Ua hoʻemi ʻia ʻo Hemoglobin

▪ Hoʻonui i nā enzymes ate

▪ Nusea

▪ Ke noi nei

▪ Hoʻonui i ka creatinine

▪ ʻeha ʻōpū

▪ Luhi

▪ Hoʻonui ʻia ka glucose

▪ Hoʻoemi i ka phosphate

▪ Hoʻoemi i ka makemake

ʻO AASraw ka mea hana ʻoihana Ceritinib.

E ʻoluʻolu e kaomi ma aneʻi no ka ʻike ʻōlelo. pākuʻiHana iā mākou

 

ʻO kēia mau hopena a ʻoi aku ka hopena o ka hopena (i loaʻa ma kahi o 10-29%) o nā maʻi e loaʻa ana ka ceritinib:

▪ Kaohi paʻa

▪ Hoʻonui ʻia ka lipase

▪ Ka maʻi esophageal (Hoʻā ka puʻuwai, dispepsia, disphagia)

▪ Kahiki

▪ Ua hoʻonui ʻia ʻo Bilirubin (huina)

ʻO kahi hopena koʻikoʻi, akā nui ʻole o ka ceritinib he pneumonitis (ʻōhū o nā akemāmā). I ka hopena o kēia hopena, hele pinepine ʻia me ka paʻakikī hanu me ka pākeke a i ʻole ke kuni haʻahaʻa e koi ana i ka haukapila. E like paha nā ʻōuli me kēlā mau hōʻailona mai ka maʻi ʻaʻai māmā. E kāhea koke aku i kāu lawelawe mālama ola inā loaʻa iā ʻoe nā hōʻailona hou a i ʻole worsening paha.

ʻO kekahi hopena koʻikoʻi akā nui ʻole ka hopena o ceritinib ka hoʻololi ʻana o EKG. ʻAʻole i helu ʻia nā hopena ʻaoʻao āpau ma luna. Kākaʻikahi kekahi mau mea (e hana ana ma lalo o 10% o nā maʻi) ʻaʻole i helu ʻia ma aneʻi. Eia nō naʻe, pono ʻoe e hoʻomaopopo mau i kāu mea mālama ola inā ʻike ʻoe i nā ʻōuli maʻamau.

 

Ceritinib

 

He aha nā pono ʻē aʻe o Ceritinib i hōʻike ʻia i loko o nā noiʻi?

I loko o ʻelua o kēia mau aʻo ʻana, e pili ana i nā maʻi he 303, ʻaʻole i hoʻohālikelike ʻia ka lāʻau i kekahi lāʻau ʻē aʻe. Ua nānā ʻia ka pane i ka mālama ʻana me ka hoʻohana ʻana i ka scans o ke kino a me nā pae hoʻohālikelike i hoʻohana ʻia no nā tumors paʻa, me ka pane piha ʻana inā ʻaʻohe koena o ka maʻi maʻi o ka maʻi ʻaʻai. I hoʻokahi noiʻi 56% o nā maʻi i hāʻawi ʻia ceritinib (92 o 163) i manaʻo ʻia e nā kauka lapaʻau e hōʻike ana i kahi pane piha a hapa paha i ka lāʻau. ʻO ka lōʻihi awelika o ka pane he 8.3 mau mahina. I ka lua o ka noiʻi, ʻo ka nui o ka pane pane he 41% (57 o 140 mau maʻi) a ʻo ka awelika o ka lōʻihi pane he 10.6 mahina.

I ke kolu o ka noiʻi ʻana ma nā maʻi he 231, ua hoʻohālikelike ʻia ka ceritinib me ka chemotherapy maʻamau (nā lāʻau e mālama ai i ka maʻi ʻaʻai. Ua hōʻike ʻia nā hopena i ola nā mea maʻi ceritinib no ka awelika o 5.4 mau mahina me ka ʻole o ko lākou maʻi e ʻoi aku ka maikaʻi (ke ola ʻole me ka holomua) hoʻohālikelike ʻia me 1.6 mau mahina i hāʻawi ʻia i ka chemotherapy maʻamau.

Ceritinib ua hōʻike ʻia he maikaʻi i ka mālama ʻana i nā mea maʻi i mālama ʻole ʻia ma mua i kahi noi ʻana ma 376 mau maʻi. Ua hāʻawi ʻia nā mea maʻi ceritinib no ka awelika o 16.6 mau mahina me ka ʻole o ko lākou maʻi maʻi e hoʻohālikelike ʻia me 8.1 mau mahina i nā mea maʻi i hāʻawi ʻia i ka chemotherapy maʻamau.

 

Loaʻa ʻo Ceritinib i ka ʻĀpono o ka lālani FDA no ka maʻi maʻi maʻi maʻi ALK-Positive Lung

Ua hoʻonui ka FDA i ka ʻae no ceritinib. Ua ʻae ʻia ka agena ma ke ʻano he lālani mua i nā mea maʻi me ka metastatic, ALK-maikaʻi, maʻi ʻaʻai liʻiliʻi liʻiliʻi ʻole. Ua hoʻonui ka US Food and Drug Administration (FDA) i ka ʻae ʻia no ceritinib. Ua ʻae ʻia ka agena ma ke ʻano he lālani mua i nā mea maʻi me ka metastatic, ALK-maikaʻi, non-small-cell lung cancer (NSCLC).

Ua ʻae ʻia ʻo Ceritinib (LDK378) ma 2014 no ka ALK-maikaʻi metastatic NSCLC i nā maʻi i hele i mua a i ʻole hoʻomanawanui i crizotinib. ʻO ka agena kahi mea koho ALK oral oral select, me ka ikaika i iwakālua mau manawa ʻo crizotinib.

Hoʻokumu ʻia ka hōʻailona hou ma nā hopena o ka hoʻokolokolo ASCEND-4, a ʻo nā hopena i paʻi ʻia i Ianuali o kēia makahiki ma Lancet. Hoʻoholo ka hoʻokolokolo i nā maʻi 376 me ka metastatic NSCLC me ka hoʻoponopono hou ʻana o ALK i kekahi ceritinib (189 mau maʻi) a i ʻole ka platinum-pemetrexed doble therapy (187 mau maʻi).

ʻO ka hopena kumu mua ke ola-manuahi holomua, a ʻoi aku ka maikaʻi o ka ceritinib. ʻO ke ola waena-manuahi ka holomua me 16.6 mau mahina me ka lāʻau lapaʻau, ke hoʻohālikelike ʻia me 8.1 mau mahina i ka lima chemotherapy, no ka lakio makaʻu o 0.55 (95% CI, 0.42-0.73; P <.0001).

ʻOi aku ka maikaʻi o ka pane pane holoʻokoʻa, ma 73% me ceritinib a me 27% me chemotherapy. ʻO ka lōʻihi o ka pane waena he 23.9 mau mahina me ka ceritinib a me 11.1 mau mahina me ka platinum / pemetrexed. I kēia manawa, noho kino ʻole ka ʻikepili ke ola holoʻokoʻa. Ua hāʻawi ʻia ʻo Ceritinib i ka inoa Breakthrough Therapy e ka FDA, me kahi loiloi mua no ka hoʻomaʻamaʻa laina mua i kēia heluna kanaka maʻi.

Ua nānā pū ka noiʻi ASCEND-4 i nā helu pane i nā mea maʻi me nā leona kikowaena o ke kikowaena e ana ʻia. ʻO 57% ka helu pane pane intracranial i hōʻoia ʻia me ka ceritinib, hoʻohālikelike ʻia me 22% me ka chemotherapy.

Ua loaʻa nā hanana kūpilikiʻi koʻikoʻi (AEs) ma 38% o nā mea maʻi i mālama ʻia me ceritinib, a me nā AE e alakaʻi ana i ka hoʻopau ʻia ʻana o ka lāʻau i 12%. ʻO nā kahakaha hana ma muli o nā AE i ʻike ʻia ma 77% o nā mea maʻi ceritinib, a me 66% e koi ai i nā hoʻoliʻiliʻi o ka lāʻau. ʻO nā AE e maʻa mau me ka lāʻau i ASCEND-4 i komo pū me ka maʻi diarrhea, nausea, ka luaʻi, ka luhi, a me ka ʻeha o ka ʻōpū. "ʻO ka ʻāpono o kēia lā ka hana hou aʻe i ka hoʻomohala ʻana o Zykadia ma ke ʻano he koho lapaʻau no ka ALK-positive metastatic NSCLC, e lawe ana i kēia lāʻau lapaʻau koʻikoʻi i kahi heluna kanaka maʻi kahi e pono ai kahi hemahema," i ʻōlelo ʻia e ka CEO ʻo Novartis Oncology ʻo Bruno Strigini, i kahi hōʻike nūpepa

ʻO AASraw ka mea hana ʻoihana Ceritinib.

E ʻoluʻolu e kaomi ma aneʻi no ka ʻike ʻōlelo. pākuʻiHana iā mākou

 

Reference

[1] Mano H: The EML4-ALK oncogene: ke kuhi nei i kahi mea hoʻokele ulu ulu nui i ka maʻi ʻaʻai kanaka. ʻO Pro Jpn Acad Ser B Phys Biol Sci. 2015; 91 (5): 193-201. hana: 10.2183 / pjab.91.193. [PubMed: 25971657].

[2] Soria JC, Tan DS, Chiari R, Wu YL, Paz-Ares L, Wolf J, et al. (Malaki 2017). "ʻO ka ceritinib lālani mua me ka chemotherapy ma muli o ka platinum i holomua i ka maʻi ʻaʻai liʻiliʻi liʻiliʻi liʻiliʻi ALK-ASCEND-4: kahi randomized, open-label, phase 3 study". Lancet. 389 (10072): 917-929.

[3] Xuan C, Gunduz V. "NSCLC MARKET - Kālā Laulaha Laulaha Laulaha & ʻIkepili Kūʻai i 2025". Hoʻolālā Lapaʻau & Hoʻouna. No Nowemapa – Kekemapa 2016.

[4] "Ua ʻae ʻo FDA iā Ceritinib no ka maʻi maʻi maʻi maʻi ALK-Positive". Medscape. 29 ʻApelila 2014.

[5] Au TH, Cavalieri CC, Stenehjem DD Ceritinib: Kahi mea hoʻomaka no nā kauka lāʻau // Oncology pharmacy hana. - 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 ʻO Anaplastic Lymphoma Kinase-Hoʻonohonoho hou ʻia i ka maʻi ʻaʻai liʻiliʻi liʻiliʻi ʻole a i ʻole nā ​​tumula ʻē aʻe. J Thorac Oncol. 378 Jul; 2015 (10): 7-1058. hana: 66 / JTO.10.1097. [PubMed: 0000000000000566].

[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 : Ka ʻike o NVP-TAE684, kahi mea hoʻokūkū ikaika, koho, a me ka hopena maikaʻi o NPM-ALK. ʻO Proc Natl Acad Sci US A. 2007 Ian 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: Synthesis, pili-hana pilina, a me ka vivo efficacy o ka puke mana a me ka wae anaplastic lymphoma kinase (ALK) mea kāohi 5-chloro-N2- (2-isopropoxy-5-methyl-4- (piperidin-4-yl) phenyl) -N4- (2- (isopropylsulf onyl) phenyl) pyrimidine-2,4-diamine (LDK378) i kēia manawa i ka pae 1 a me ka pae 2 clinical nā hoʻāʻo. ʻO J Med Chem. 2013 Jul 25; 56 (14): 5675-90. hana: 10.1021 / jm400402q. Epub 2013 Jun 26. [PubMed: 23742252].

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