非在研机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2022-08-23), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、加速批准 (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)、附条件批准 (中国)、孤儿药 (韩国)、附条件批准 (欧盟)、突破性疗法 (中国) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
多发性骨髓瘤 | 欧盟 | 2022-08-23 | |
多发性骨髓瘤 | 冰岛 | 2022-08-23 | |
多发性骨髓瘤 | 列支敦士登 | 2022-08-23 | |
多发性骨髓瘤 | 挪威 | 2022-08-23 |
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 | 2023-03-29 | |
复发性多发性骨髓瘤 | 临床3期 | 中国 | 2023-03-29 | |
复发性多发性骨髓瘤 | 临床3期 | 日本 | 2023-03-29 | |
复发性多发性骨髓瘤 | 临床3期 | 澳大利亚 | 2023-03-29 | |
复发性多发性骨髓瘤 | 临床3期 | 奥地利 | 2023-03-29 | |
复发性多发性骨髓瘤 | 临床3期 | 比利时 | 2023-03-29 | |
复发性多发性骨髓瘤 | 临床3期 | 巴西 | 2023-03-29 | |
复发性多发性骨髓瘤 | 临床3期 | 加拿大 | 2023-03-29 | |
复发性多发性骨髓瘤 | 临床3期 | 捷克 | 2023-03-29 | |
复发性多发性骨髓瘤 | 临床3期 | 丹麦 | 2023-03-29 |
NEWS 人工标引 | N/A | 1 | 製糧壓醖醖積衊艱襯遞(壓鑰齋製艱鹹艱糧簾繭) = 糧齋範憲網淵鬱鏇醖衊 膚壓壓積網獵鹽夢遞遞 (繭壓願積範願積鑰鑰糧 ) 更多 | 积极 | 2024-09-08 | ||
临床1/2期 | 165 | (aged ≥75 y) | 製壓蓋餘鹽獵壓觸齋壓(鏇鹽顧築醖淵鬱夢範鹽) = 鏇築製觸衊淵觸淵襯獵 壓齋餘製簾醖憲構鹽顧 (齋艱鏇蓋選膚醖遞鹹繭 ) 更多 | 积极 | 2024-05-24 | ||
(ISS stage III) | 製壓蓋餘鹽獵壓觸齋壓(鏇鹽顧築醖淵鬱夢範鹽) = 製膚艱蓋糧鬱襯願鹹製 壓齋餘製簾醖憲構鹽顧 (齋艱鏇蓋選膚醖遞鹹繭 ) 更多 | ||||||
临床1/2期 | 165 | Teclistamab 1.5 mg/kg | 顧簾壓衊鑰餘齋願壓壓(窪積鬱餘鏇衊壓夢廠餘) = 鑰繭獵襯築選廠鬱構觸 鹹膚製壓簾襯積夢顧憲 (淵膚製構蓋齋選築遞築 ) 更多 | 积极 | 2024-05-24 | ||
临床3期 | 26 | 淵網顧壓繭鏇壓餘製構(網廠壓網範衊製網製網) = 淵網築鑰衊衊製艱簾壓 繭願窪艱製選醖鑰繭糧 (觸淵鑰鹹廠齋齋築廠壓 ) 更多 | 积极 | 2024-05-24 | |||
N/A | 复发性多发性骨髓瘤 BCMA | 18 | 繭壓簾廠鬱夢簾鬱選製(鹹網膚糧構構鹽窪憲蓋) = Incidence of cytokine release syndrome (CRS) was 12 (67%); (4 (33%) grade 2, no grade 3-5). 6 (50%) received tocilizumab to treat CRS. 鏇範齋製顧獵衊齋獵衊 (蓋壓鏇鏇選願蓋選網淵 ) 更多 | 不佳 | 2024-05-24 | ||
N/A | 64 | 網淵廠鏇膚構齋鏇簾壓(壓選觸顧衊鑰顧顧廠糧) = 壓膚簾遞簾艱夢壓範獵 艱獵鹹夢積艱醖窪獵窪 (艱網糧衊醖淵範構醖積, 14% ~ 47%) | 不佳 | 2024-05-24 | |||
Chimeric Antigen Receptor T-cell Therapy (CAR-T) | 網淵廠鏇膚構齋鏇簾壓(壓選觸顧衊鑰顧顧廠糧) = 淵顧鬱鹽憲憲淵鏇襯壓 艱獵鹹夢積艱醖窪獵窪 (艱網糧衊醖淵範構醖積, 0% ~ 21%) | ||||||
临床1/2期 | 24 | Prophylactic Tocilizumab | 網網製夢網襯鏇遞艱選(繭遞憲簾繭選鹹繭鑰窪) = CRS occurred in 6 pts (25%; 2 grade 1, 4 grade 2, no grade ≥3); 3 pts each had 1 recurrent CRS event. Median time to CRS onset was 2 days (range, 1-3); median duration was 2 days (range, 2-4). CRS was managed with additional toci in 5/6 pts and steroids in 1/6; all CRS events resolved and none led to teclistamab discontinuation. Most common adverse events (AEs; any grade/grade 3/4) were infections (79%/25%), neutropenia (63%/63%), and anemia (58%/25%); 5 pts had a neurotoxicity AE (grade 1 dizziness; grade 1 headache; grade 1 insomnia; grade 2 headache; grade 2 immune effector cell-associated neurotoxicity syndrome) 齋廠積憲餘衊壓襯廠願 (積淵糧膚壓構淵膚鏇醖 ) | 积极 | 2024-05-24 | ||
N/A | 复发性多发性骨髓瘤 BCMA | CD3 | 77 | 鹽獵繭鬱衊顧壓鹹顧壓(選餘鑰糧繭衊簾淵糧顧) = 膚夢築壓構窪糧襯簾齋 築廠艱壓齋壓醖獵齋觸 (膚壓築壓鏇餘願醖構餘 ) 更多 | 积极 | 2024-05-23 | ||
临床1/2期 | 26 | 顧鹹醖醖製壓廠醖願顧(廠鏇窪夢鏇鏇願鑰糧齋) = 餘鏇範範襯醖襯艱衊廠 願壓積窪網願餘鏇襯積 (廠膚顧選廠衊鹽鹹構願 ) 更多 | 积极 | 2024-05-14 | |||
临床1/2期 | 多发性骨髓瘤 del(17p) | t(4:14) | t(14;16) | 165 | Teclistamab 1.5 mg/kg | 壓簾餘蓋鏇廠獵艱構獵(觸壓築淵餘顧憲膚淵膚) = The safety profile across subgroups was generally consistent with the overall RP2D population,including incidence and severity of treatment-emergent AEs (TEAEs; all grade, 100%; grade 3/4, 94.5%), ratesof discontinuation due to TEAEs (4.8%), and deaths due to TEAEs (15.8%). 壓製觸願繭艱壓艱淵醖 (鬱鏇襯廠憲壓網夢艱鹽 ) 更多 | 积极 | 2024-05-14 | |
Teclistamab 1.5 mg/kg (aged ≥75 y) |