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ҳ >> Ѷ >>ӡȿҩѶ >> Lenvatinib Lenvanix 10mg Beacon ַ ? 10mg μHCC;IRCC;נٰDTC
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Lenvatinib Lenvanix 10mg Beacon ַ ? 10mg μHCC;IRCC;נٰDTC

Ʒ

ƷƣLenvatinib Lenvanix 10mg Beacon ַ ? 10mgƷţECS000290̣Mzmall International50

ӢQLenvatinib

Qᣨ?ᣩ

Ʒ Lenvanix

Ҏ10mg/ 30/ƿ

?SңϼBeacon


aƷB:

?ᣨLenvatinibg飺ᣩаl̖E7080ձlģ Eisai˾аlҼNcwҰἤøRTKƄVEGFR1VEGFR2VEGFR3cѪܡ[LYMչPRTKwSLӣFGFwFGFR1,2,3,4ѪСܻLwPDGFRKITRET


2015FDA͚WˎƷEMA?ίuԡֲڻDԷֻͼנٰ2016FDA͚WEMA^?“SĪ˾ίI


20183£?ձ@m춲гĸμHCCߵҼί@ԓˎȫ״Ϋ@춸μίmYʣҲձ10?ׂǰίĸΰϵy


ίIϣSĪ˾Ҽˎ?SĪ˾“ˎLߟoMչ(PFS)߻߿^ʺͿʡоY@ʾ?SĪ˾“ˎMλPFS14.6£SĪ˾ҼˎMλPFS5.5£˽3ȆҼˎM“ˎM߼MչLUɽ63%“ˎM^ʞ37%ҼˎM6%“ˎM߿ڣOS25.5£ҼˎM15.4¡


ҼίgгĸμΰR[WASCO2017ϰl?IIIRԇREFLECTо@ʾҪKc棬?MڣOS^MLڅݣڴҪKc棬oMչڣPFS?27.4 vs 3.7£λMչrgmTTPͿ^ȫ泬Խᣨ8.9 vs 3.7£24% vs 9%REFLECTоҼȫSC_ʽЧNIRо?REFLECT оϵľ޴ɹ򌢸׃ʮ?ΰˎίĬF


̿ˎaLenvanix?ȫ׷ˎҲֹΨҼ@OܙCʺϷaķˎ


̿ˎɚWؔFcͶY?؅^ΨҼКW˼gҎ?KϼɴCȯеĴˎIaƷϚWˎˎ˜ʡ


?Դ^ͬҼNˎʹҪɷݺc̿aƷӽ춲߂ҎGMP˜aTćOܣaƷӰˎʵܳȺöҲc̿aƷкܴ?


鱣CˎȫՈ֔x








mY:

1. μίгĸμHCCߣ

2. ֻͼנٰˎ춾ֲ?Ͱl/DơMչķԵyԷֻͼנٰߣ

3. IcSĪ˾“ãί^Ѫ܃ƤLӰ򯟷Iߡ



÷c:


1. נٰDTCÿ24mgڷÿҼΣ

2. IRCC18mg?+5mgSĪ˾ڷÿҼΣ

3. μHCCwء60kg12mgÿҼΣwأ60kg8mgÿҼΡ


?ÿͬҼrgáӛˎ?Kδ12Сrȿڷ^ԓ΄?KԭˎrgҼ΄

?zґ̷zܽСҺwáȡҼ󜫳׵ˮO֭춲zңzҲ_飩zoҺw10犣3ᣬҺwᣬټҼ󜫳ףˮO֭춲УʣҺw



Ϣ硣


aƷϼaƷϼֱ]10-20쵽У؅^ՈJԃͷǷPPrǷڱPҪJԃغP˾Hؓ؟lصPհһ˻أ˻ؿ°l]MˣՈ֪Ϥ