Country: Taiwan
Bahasa: Cina
Sumber: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
Alectinib HCl
台灣中外製藥股份有限公司 台北市松山區敦化北路260號3樓 (23060795)
L01ED03
膠囊劑
Alectinib HCl (1013006110) (equivalent to Alectinib......150mg)MG
鋁箔盒裝
製 劑
須由醫師處方使用
BUSHU PHARMACEUTICALS LTD. MISATO FACTORY 950 HIROKI OHAZA MISATO-MACHI KODAMA-GUN SAITAMA-KEN, JAPAN JP
alectinib
ALECENSA®適用於治療ALK陽性的晚期非小細胞肺癌(NSCLC)患者。
有效日期: 2027/01/21; 英文品名: ALECENSA 150mg capsules
2017-01-21
1 ALECENSA ® ALK NSCLC 2 2.1 ALK NSCLC ALK ALECENSA ® ALK ALK 1 14 2.2 ALECENSA ® 600 12.3 ALECENSA ® Child-Pugh C ALECENSA 450 8.7 12.3 ALECENSA ® ALECENSA ® ALECENSA ® 2.3 ALECENSA ® 1 1. ALECENSA ® 600 450 300 300 ALECENSA ® 2 2. ALECENSA ® A ALECENSA ® ALT AST 5 ULN 2 ULN 3 ULN 1 ALT AST 3 ULN 2 ULN ALECENSA ® 3 ULN 1.5 ULN 1 ILD / pneumonitis ALECENSA ® 3 1.5 ULN 1 4 ALECENSA ® ALECENSA ® 60 bpm 60 bpm ALECENSA ® 60 bpm 1 ALECENSA ® 30 89 / alectinib M4 30 / alectinib 300 ALECENSA ® alectinib M4 AUC inf Child-Pugh B [ 90 CI ] 1.36 [ 0.947,1.96 ] Child-Pugh C [ 90 CI ] 1.76 [ 0.984,3.15 ] Alectinib M4 C max ALECENSA ® 450 2.2 8.7 Alectinib ALECENSA ® CYP3A posaconazole CYP3A rifampin esomeprazole alectinib M4 Alectinib ALECENSA ® midazolam CYP3A repaglinide CYP2C8 alectinib M4 CYP1A2 2B6 2C9 2C19 2D6 alectinib M4 P-gp BCRP Alectinib OATP1B1 OATP1B3 OAT1 OAT3 OCT2 13 13.1 alectinib Alectinib Ames alectinib 14 ALK NSCLC ALECENSA ® ALK NSCLC ALEX ECOG PS 0-2 Ventana ALK D5F3 CDx ALK 14 QTc > 470 ms 1:1 ALECENSA ® 600 crizotinib 250 ECOG PS 0/1 vs. 2 vs. CNS vs. RECIST v1.1 PFS IRC PFS IRC RECIST v1.1 CNS ORR DOR OS CNS IRC CNS CNS-ORR CNS CNS-DOR 3 0 3 ALECENSA ® n = 1 5 2 c r i z o t i n i b n=151 56% 56 18-91 50% 46% 1% 3% 92% 63% 40% n=122 CNS 43 IRC CNS ALEX ALECENSA ® PFS IRC CNS crizotinib ALECENSA ® CNS crizotinib 45% vs. ALECENSA ® 12% ALEX 7 1 7. ALEX IRC ALECENSA N=152 CRIZOTINIB N=151 % 63 41% 92 61% % 51 34% 82 54% % 12 8% 10 7% 95% CI 25.7 19.9, NE 10.4 7.7, 14.6 95% CI a 0.53 0.38, 0.73 74% 60% CNS 65% CNS 43% 36% 34% NP28673 138 52 22 79 10% 65 67% 26% 56% 32% ECOG PS 0 59% ECOG PS 1 98% 99% IV 96% 80% 61% CNS 73% CNS 51% 38% 30% NP28761 NP28673 9 NP28761 IRC 17 NP28673 21 IRC 2 NP28761 3 NP28673 9. NP28761 NP28673 NP28761 N=87 NP28673 N=138 IRC* IRC* 95% CI 42.5% 32.0 53.6 52.9% 41.9 63.7 44.9% 36.5 53.6 51.4% 42.8 60 37 46 62 71 95% CI 14.9 7.5 13.3 8.8 18.2 15.2 11.2 24.9 13.7 11.0 20.3 * 20 NP28761 16 NP28673 IRC IRC NP28761 NP28673 50 CNS RECIST v1.1 CNS ORR 10 34 Baca dokumen lengkap