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がん個別化医療実現のための課題 - pmda.go.jp

2013/11/15 PMDAPMDA 1 Driver gene fraction Approvedand Potentially effective molecular targeting agents CrizotinibLapatinibVemurafenibTemsirolim usSelumetinibCrizotinibVandetanib, Sorafenib,CabozantinibGefitinib, Erlotinib, AfatinibHER2 ALK fusionsBRAFPIK3 CAAKT1 MAP2K1 NRASROS1 fusionRET fusion*KRASEGFR unknown*KohnoT et al, Nature Medicine 18; 375-77, 20122genomepre-screening LCIHCpre-screening GCComprehensive analysis for prescreening is necessaryMolecular profile-guided therapy: 3 RET RET KIF5 BRET 10 (Kohno et al., Takeuchi et al., Lipson et al., Nat Med, 2012) 30 (NCC ) RNA 2% RET RET 4 1% ALK 1/5 1500 -2000 EPOC 1301:RET Vandetanib II :LURET RET RT-PCRFFPE FISH DNA 20 ECOG PS0- 2 1 Vandetanib300mg/day1 1 28 1 Primary endpoint Secondary endpoints PFS OS 17 70% 40% 80% 2 1 5 24 : 5 RET LC-SCRUM-JapanAnother new agent studies for ROS1, BRAF, EGFR-T

がん個別化医療実現のための課題 国立がん研究センター 大津敦 2013/11/15 pmda. pmda. 科学委員会 医薬品・バイオ製品合同専門部会話題提供

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