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Osimertinib (AZD-9291) powder

mlingo:
5.00 kuchokera 5 kutengera 1 kasitomala mlingo
SKU: 1421373-65-0. Category:

AASraw ili ndi kaphatikizidwe ndi kapangidwe kameneka kuchokera ku gramu mpaka kulemera kwa ufa wa Osimertinib (AZD-9291) powika (1421373-65-0), pansi pa lamulo la CGMP ndi dongosolo loyendetsa khalidwe labwino.

Osimertinib (AZD-9291) powder ndi mankhwala osokoneza bongo a epidermal factor receptor (EGFR) othandizira komanso T790M kusinthika kusintha (IC50s = 15-17 nM) pamene akusunga mawonekedwe a mtundu wa receptor (IC50 = 480 nM) .1 Ndilo linagwirizana ndi IGF1R Zomwe zimapangitsa kuti thupi likhale lopweteka kwambiri, limakhala lopweteka kwambiri. 50 AZD 2.9 yasonyezedwa kuti imaletsa kukula kwa chifuwa mumtundu wa 16.2-1 mg / kg. khansa yapakhungu yochepa ya EGFR yochepa.

Mafotokozedwe Akatundu

Mavidiyo a ufa wa Osimertinib (AZD-9291)


Osimertinib (AZD-9291) powder Anthu oyambirira

Name: Osimertinib (AZD-9291) powder
CAS: 1421373-65-0
Makhalidwe a Maselo: C28H33N7O2
Kulemera kwa maselo: 499.61
Melt Point: > 188ºC
Kusungirako nyengo: -20 ° C
mtundu; Kuwala chikasu cholimba ufa


Osimertinib (AZD-9291) ufa mu ntchito

dzina

AZD-9291 powder (CAS 1421373-65-0), N-[2-[[2-(dimethylamino)ethyl]methylamino]-4-methoxy-5-[[4-(1-methyl-1H-indol-3-yl)-2-pyrimidinyl]amino]phenyl]-2-propenamide

Kugwiritsira ntchito Powder AZD-9291

Mankhwala a AZD-9291 omwe amathandizidwa kamodzi tsiku lililonse pamtundu wa 5 mg / makilogalamu amachititsa kupweteka kwakukulu kwa zotupa pa EGFRm + (PC9; 178% kukula kwa chiopsezo) ndi EGFRm + / T790M (H1975; 119% kukula)
Pambuyo masiku 14 akutsatira. Kuwonjezera apo 5 mg / kg AZD-9291 ufa inali yokwanira kuti ziwonongeke kwambiri za EGFRm + ndi EGFRm + / T790M transgenic mouse mammimba mapaipi. Kupewa kupweteka kwa mimba kunkaphatikizapo kutetezedwa kwakukulu kwa EGFR phosphorylation ndi njira zazikulu zowonetsera pansi monga AKT ndi ERK. Kuchiza kwa nthawi yaitali kwa ziphuphu za PC9 ndi H1975 xenograft ndi ufa wa AZD-9291 kumayambitsa ndondomeko yowonjezereka ndi yotsimikizika, yosakhala ndi ziphuphu zooneka pambuyo pa masiku a 40, ndikukhalabe opitirira masiku 100. Kuwonjezera pamenepo, deta yapitayi imasonyeza kuti ufa wa AZD-9291 ukhoza kuyambitsa ziwalo zomwe zakhala zikutsutsana ndi njira yowonjezera yowonjezera ya HER2, kotero kuti ikhoza kuonjezera ubwino wake odwala TKI.

Chenjezo pa AZD-9291 powder

Mankhwala a AZD-9291 (CAS 1421373-65-0) ndi mankhwala okhawo amene amavomerezedwa kwa odwala omwe ali ndi matenda a EGFR T790M osagwirizana ndi maselo osaphatikizapo. Chizindikiro ichi chikuvomerezedwa pansi pa njira yovomerezeka ya FDA yowonjezereka chifukwa cha kuchuluka kwa chiwerengero cha matenda ndi nthawi ya mayankho (DoR).

Zomwe zimawonongeka zambiri zimaphatikizapo kutsegula m'mimba, stomatitis, rashes, khungu louma kapena lopweteka, matenda omwe pamanja kapena pamutu pamakhala chikopa, chiwerengero chochepa cha platelet, chiwerengero chochepa cha lekocyte, ndi chiwerengero chochepa cha neutrophil.
Palibe zotsutsana za TAGRISSO
Matenda a Mitsempha (ILD) / Pneumonitis inapezeka mu 3.3% ndipo anali ophedwa mu 0.5% a odwala 813 TAGRISSO. Musalole TAGRISSO ndipo fufuzani mofulumira kwa ILD mukulankhulirana kulikonse komwe mukukhala ndi zizindikiro zozizira za ILD (mwachitsanzo, dyspnea, chifuwa ndi malungo). Kuleka TAGRISSO kwamuyaya ngati ILD ikutsimikiziridwa
Kutalika kwa nthawi ya QTc kunachitika odwala TAGRISSO. Pa odwala 411 mu maphunziro awiri a Phase II, wodwalayo (0.2%) adapezeka kuti ali ndi QTc wamkulu kuposa 500 msec, ndipo odwala 11 (2.7%) adakula kuchokera ku QTc wamkulu kuposa 60 msec. Chitani nthawi ndi nthawi kuyang'anira ndi ECGs ndi electrolytes kwa odwala omwe ali ndi matenda a QTc otha msinkhu, kupweteka mtima kwa mtima, kuperewera kwa electrolyte, kapena omwe akumwa mankhwala omwe amadziwika kuti amatenga nthawi ya QTc. Kuleka TAGRISSO kwamuyaya kwa odwala omwe amatha kupitiriza kutalika kwa QTc ndi zizindikiro / zizindikiro za moyo wowopsya.
Kusakaza thupi kunayambira mu 1.4% ndipo anali ophedwa mu 0.2% a odwala 813 TAGRISSO. Mzere Wosakanikirana wa Ejection (LVEF) ukuchepa> 10% ndi dontho ku <50% linapezeka ku 2.4% ya (9 / 375) Odwala TAGRISSO. Ganizirani LVEF musanayambe ntchito ndipo kenako panthawi ya mankhwala a 3. Pewani TAGRISSO ngati kachigawo kakang'ono ka ejection kakachepetsedwa ndi 10% kuchokera ku chikhalidwe choyendetsa thupi ndipo sichichepera 50%. Kwa kusayenerera kwa mtima kusagwedezeka kwapadera kapena kusagwira ntchito kosavomerezeka kwa LV komwe sikungathetse mkati mwa masabata a 4, kuthetsa kwathunthu TAGRISSO.
Awalangizeni amayi omwe ali ndi chiopsezo chotengera mwana. Alangizeni amayi omwe ali ndi mphamvu zobereka kuti agwiritse ntchito njira zowathandiza kulera nthawi ya TAGRISSO mankhwala ndi masabata a 6 pambuyo pa mlingo womaliza. Alangizeni amuna ndi akazi omwe ali ndi mphamvu zobereka kuti agwiritse ntchito njira zowathandiza kubereka kwa miyezi ya 4 pambuyo pa mlingo womaliza.
Zomwe zimayambitsa mavuto ambiri (> 20%) zogwirizana ndi TAGRISSO odwala anali kutsekula m'mimba (42%), kuthamanga (41%), khungu louma (31%) ndi misomali ya msomali (25%).

Maumboni ena

Mankhwala a AZD-9291 anali othandiza kwambiri kwa odwala khansa ya m'mapapo ndi kusintha kwa EGFR T790M amene anadwala matenda opatsirana pogonana ndi EGFR tyrosine kinase inhibitors.

Pulogalamu ya AZD-9291 ikuphunziridwa mu mayesero ovomerezeka, AURA3, malemba otseguka, kufufuza kwa Phase III yopangidwira kuti atsimikizire kuti zowonjezera ndi chitetezo cha AZD-9291 powder pamodzi ndi platinum-based doublet chemotherapy kwa odwala omwe ali ndi EGFR T790M zabwino, kapena metastatic NSCLC amene apititsa patsogolo chithandizo cham'mbuyomo ndi EGFR-TKI. Mankhwala a AZD-9291 akufufuzidwanso mu adjuvant komanso mu mzere woyamba wa mzere, kuphatikizapo odwala omwe ali ndi ubongo metastases, komanso kuphatikizapo mankhwala ena.

Mankhwala a AZD-9291 80mg kamodzi patsiku ndilo mankhwala oyamba omwe amasonyeza kuti akuchiritsidwa ndi odwala omwe ali ndi matenda osokoneza bongo (EGFR) a T790M omwe ali ndi kansa ya m'mapapo (NSCLC), omwe amavomereza ndi FDA. kuyesa, omwe apititsa patsogolo kapena pambuyo pa EGFR tyrosine kinase inhibitor (TKI) mankhwala. Kafukufuku wosagwiritsidwa ntchito mu mavitro awonetsetsa kuti ufa wa AZD-9291 uli ndi mphamvu zowonongeka motsutsana ndi kutuluka kwa EGFR phosphorylation pamtunda wa EGFRm komanso magetsi a T790M osinthika a NSCLC ndi ntchito zochepa zotsutsana ndi EGFR muzitsulo zamtundu.

Mafuta a Osimertinib atsindikizidwa posachedwapa ndi World Health Organization (WHO) monga momwe bungwe la International Non-proprietary Name (INN) loperekera la AZD-9291, ndipo lingakhale lovomerezeka mwa November 2015. Ku US, American Medical Association inavomereza mafuta a Osimertinib monga dzina la United States Adopted Name (USAN).

Poda ya AZD-9291 (CAS 1421373-65-0)

10grams yayamba.
Funso labwino kwambiri (mkati mwa 1kg) lingatumizedwe mu maola a 12 mutatha kulipira.
Kuti mukhale wamkulu (mkati mwa 1kg) mukhoza kutumizidwa mu tsiku la ntchito 3 mutatha kulipira.

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Mungagule bwanji ufa wa Osimertinib; Gulani ufa wa AZD-9291 (CAS 1421373-65-0) kuchokera ku AASraw

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