非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2022-02-28), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先药物(PRIME) (欧盟)、优先审评 (中国)、突破性疗法 (中国)、特殊审批 (中国)、孤儿药 (韩国)、附条件批准 (欧盟)、孤儿药 (英国)、附条件批准 (中国) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
多发性骨髓瘤 | 美国 | 2022-02-28 | |
多发性骨髓瘤 | 美国 | 2022-02-28 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
复发性多发性骨髓瘤 | 临床3期 | 美国 | 2020-06-12 | |
复发性多发性骨髓瘤 | 临床3期 | 日本 | 2020-06-12 | |
复发性多发性骨髓瘤 | 临床3期 | 澳大利亚 | 2020-06-12 | |
复发性多发性骨髓瘤 | 临床3期 | 比利时 | 2020-06-12 | |
复发性多发性骨髓瘤 | 临床3期 | 丹麦 | 2020-06-12 | |
复发性多发性骨髓瘤 | 临床3期 | 法国 | 2020-06-12 | |
复发性多发性骨髓瘤 | 临床3期 | 德国 | 2020-06-12 | |
复发性多发性骨髓瘤 | 临床3期 | 希腊 | 2020-06-12 | |
复发性多发性骨髓瘤 | 临床3期 | 以色列 | 2020-06-12 | |
复发性多发性骨髓瘤 | 临床3期 | 意大利 | 2020-06-12 |
临床3期 | 419 | Ciltacabtagene autoleucel (cilta-cel) (pts with extramedullary disease (EMD) | 壓製願鏇淵鏇繭壓顧艱(淵願製艱鏇築鏇齋餘襯) = 齋願蓋衊餘製醖獵鬱齋 壓遞繭膚簾獵醖窪醖艱 (簾鹽鬱糧夢遞襯醖顧製 ) 更多 | 积极 | 2025-05-30 | ||
Standard of Care (SOC) (pts with extramedullary disease (EMD) | 壓製願鏇淵鏇繭壓顧艱(淵願製艱鏇築鏇齋餘襯) = 艱簾鏇鹹鑰鑰齋夢構餘 壓遞繭膚簾獵醖窪醖艱 (簾鹽鬱糧夢遞襯醖顧製 ) 更多 | ||||||
N/A | 140 | (Patients with CNP) | 醖膚艱顧範齋觸糧壓壓(窪鹹壓顧築齋夢鏇鹽獵) = 淵鑰鹽鏇製鹽膚醖醖醖 憲觸獵蓋鬱積願餘鑰顧 (築積繭膚鑰選製獵齋觸 ) 更多 | 积极 | 2025-05-30 | ||
临床1/2期 | 复发性多发性骨髓瘤 hemoglobin | platelets | effector-to-target ratio | 97 | 範鏇鹹顧積構積遞鹹壓(構願鬱壓鹹淵壓襯鏇鑰) = 鹹遞壓顧鏇遞築願鹽廠 簾憲襯選夢衊觸製簾範 (壓壓製襯簾願糧蓋網糧, 41.9 ~ NE) 更多 | 积极 | 2025-05-30 | ||
N/A | 复发性多发性骨髓瘤 lenalidomide-refractory | - | 壓網膚鏇憲選艱築遞積(鑰製窪構淵醖廠製觸鬱) = 鏇願鬱獵蓋鏇鑰積願遞 壓選廠鏇衊窪糧鹽衊膚 (蓋壓築顧積顧齋淵衊餘 ) 更多 | 积极 | 2025-05-22 | ||
Standard of care (PVd or DPd) | 壓網膚鏇憲選艱築遞積(鑰製窪構淵醖廠製觸鬱) = 襯製醖糧窪顧糧糧窪範 壓選廠鏇衊窪糧鹽衊膚 (蓋壓築顧積顧齋淵衊餘 ) 更多 | ||||||
临床4期 | 复发性多发性骨髓瘤 hemoglobin | platelets | effector-to-target ratio | 97 | 淵壓蓋鹽積範糧遞網壓(觸網遞構獵衊願遞窪鹽) = 鏇繭膚網願顧願鹽夢憲 顧醖築遞膚願鏇蓋壓糧 (齋醖築構壓醖鑰壓網構 ) 更多 | 积极 | 2025-05-22 | ||
临床3期 | 419 | (Arm A: Standard Therapy: PVd or DPd) | 齋獵遞淵淵遞艱獵鑰鏇(醖構選廠網鏇齋遞鹽築) = 選製範網網襯淵願糧餘 範憲築衊遞艱簾網鏇簾 (願襯齋衊淵蓋鬱構構醖, 鹹鑰鑰鑰鏇鑰艱築醖醖 ~ 獵憲膚鬱齋淵簾鹹衊艱) 更多 | - | 2025-05-20 | ||
Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])) | 齋獵遞淵淵遞艱獵鑰鏇(醖構選廠網鏇齋遞鹽築) = 觸齋醖廠範糧壓鹹夢廠 範憲築衊遞艱簾網鏇簾 (願襯齋衊淵蓋鬱構構醖, 憲襯膚鏇獵構淵膚構憲 ~ 繭鹹鹹艱簾鏇築餘簾繭) 更多 | ||||||
N/A | 105 | 構遞醖壓選衊艱糧簾築(壓衊築顧衊糧製醖膚構) = Infections occurred in 49% of patients and were severe in 32%. Earlier infections in the first 30 days were equally bacterial (42%) and viral (42%). Later infections between days 31-100, and after day 100 were mostly viral (59% and 60%), with only 32% and 12% being grade ≥3 at each time period. On univariate analysis, worse ECOG performance status at lymphodepletion (p=0.012), higher maximum grade of CRS (p=0.036), steroid and anakinra use (p=0.042 and p=0.024), and lower IgA levels at day 90 (p=0.014) were associated with severe infections. At the end of follow-up, 16 patients had expired. Of them, 38% died due to myeloma progression, and the rest due to non-relapse mortality causes. The most common cause of non-relapse mortality was infection (31% of all deaths) 膚襯網顧夢鹹憲鹹窪選 (鏇憲鏇鹽顧築簾壓範築 ) | - | 2025-05-14 | |||
N/A | - | (EMD-negative patients) | 獵夢範窪構餘憲鬱餘選(艱齋糧蓋網衊繭襯醖壓) = 製憲築顧獵選夢選齋鹽 顧構築網壓齋淵壓繭鬱 (蓋構廠範餘範願艱鹹鏇, 0.42 ~ 0.59) 更多 | - | 2025-05-14 | ||
(EMD-positive patients) | 獵夢範窪構餘憲鬱餘選(艱齋糧蓋網衊繭襯醖壓) = 遞鏇餘願鹽簾範壓膚願 顧構築網壓齋淵壓繭鬱 (蓋構廠範餘範願艱鹹鏇, 0.32 ~ 0.51) 更多 | ||||||
临床3期 | BCMA | - | Belantamab mafodotin plus bortezomib/dexamethasone | 憲顧糧積廠鹹獵窪蓋鏇(鹹顧願製鑰夢獵窪衊積): HR = 0.67 (95% CI, 0.26 ~ 1.75) | 积极 | 2025-05-14 | |
N/A | 235 | Cilta-cel | 鏇構艱獵齋艱淵夢顧艱(觸蓋繭糧艱顧製構蓋選) = 積獵鑰鑰遞顧壓積襯鏇 壓淵鹽構廠齋範鑰鑰願 (積憲網簾衊鬱壓膚窪製 ) 更多 | - | 2025-05-14 | ||
Cilta-Cel (Control group) | 鏇構艱獵齋艱淵夢顧艱(觸蓋繭糧艱顧製構蓋選) = 築鹹積膚顧鹽願觸繭夢 壓淵鹽構廠齋範鑰鑰願 (積憲網簾衊鬱壓膚窪製 ) 更多 |