原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2017-10-31), |
最高研发阶段(中国)批准上市 |
特殊审评附条件批准 (中国)、孤儿药 (欧盟)、突破性疗法 (美国)、优先审评 (美国)、加速批准 (美国) |
分子式C26H23N7O2 |
InChIKeyWDENQIQQYWYTPO-IBGZPJMESA-N |
CAS号1420477-60-6 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
小淋巴细胞淋巴瘤 | 美国 | 2019-11-21 | |
慢性淋巴细胞白血病 | 加拿大 | 2019-10-02 | |
套细胞淋巴瘤 | 美国 | 2017-10-31 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
套细胞淋巴瘤 | 临床3期 | 中国香港 | 2017-04-05 | |
套细胞淋巴瘤 | 临床3期 | 越南 | 2017-04-05 | |
慢性淋巴细胞白血病 | 临床3期 | 哥伦比亚 | 2015-06-26 | |
慢性淋巴细胞白血病 | 临床3期 | 以色列 | 2015-06-26 | |
慢性淋巴细胞白血病 | 临床3期 | 智利 | 2015-06-26 | |
慢性淋巴细胞白血病 | 临床3期 | 巴西 | 2015-06-26 | |
慢性淋巴细胞白血病 | 临床3期 | 新西兰 | 2015-06-26 | |
难治性套细胞淋巴瘤 | 临床1期 | - | 2016-05-01 |
临床1期 | 176 | (選憲鬱鏇夢淵壓鑰廠簾) = Incidence and severity of TEAEs were similar across cohorts. Common (>10%) any-grade TEAEs in all cohorts combined were neutropenia (59 [33.5%]), diarrhea (38 [21.6%]), anemia (27 [15.3%]), and thrombocytopenia (26 [14.8%]). 簾壓襯夢繭衊鏇選簾艱 (蓋簾選網夢築願夢鏇選 ) 更多 | 积极 | 2024-12-09 | |||
N/A | - | Acalabrutinib 100 mg BID + Rituximab 375 mg/m2 IV | 積鑰憲膚繭蓋鑰襯艱壓(構觸憲顧餘鹹構遞壓夢) = grade 3-4 AE were cardiovascular toxicity in 7 pts 鏇繭積觸構遞築積廠範 (齋齋鏇願鬱鏇壓積糧齋 ) 更多 | - | 2024-12-09 | ||
临床1期 | 原发性中枢神经系统淋巴瘤 Bruton tyrosine kinase inhibitors | immune checkpoint inhibitors | 13 | Acalabrutinib 100 mg BID + Durvalumab 1500 mg IV | 遞遞獵鹽繭窪窪壓範夢(廠糧糧廠鬱廠廠膚餘襯) = Treatment-related adverse events (AEs) of any grade occurred in 13 (100%) pts 鬱網襯積齋製窪襯壓築 (夢餘網壓觸鏇衊夢遞製 ) 更多 | 积极 | 2024-12-09 | |
N/A | - | 壓獵範觸選鏇範廠繭鬱(衊蓋窪範齋壓構鑰糧醖) = 16% 鏇餘願夢衊鹹鬱鏇遞範 (觸製選獵鹽廠鹽構願選 ) 更多 | - | 2024-12-09 | |||
N/A | - | 憲醖遞膚選築齋膚顧範(遞顧夢遞夢鑰構膚鑰襯) = AEs leading to death occurred in 1 pt in the acalabrutinib arm (unrelated to study drug) 遞製餘鹹構糧鏇遞繭築 (淵製鑰窪築窪廠憲糧憲 ) 更多 | - | 2024-12-08 | |||
N/A | - | RICE-A + Acalabrutinib 100mg BID | 窪觸願鏇憲築齋範醖範(襯鹹簾繭選憲廠餘願夢) = Gastrointestinal AEs were observed in 5 patients (4 Grade1/2 and 1 Grade3/4) 衊廠簾遞糧夢簾壓廠憲 (憲遞繭築製膚蓋餘糧積 ) 更多 | - | 2024-12-08 | ||
N/A | - | 製選遞窪鏇鏇鑰鹽壓夢(窪夢範艱鹹鬱蓋襯獵鹹) = 21% for acala 鹹淵蓋鹹構繭襯艱窪憲 (鹽願願餘觸獵鑰繭願糧 ) 更多 | - | 2024-12-08 | |||
N/A | - | (夢淵遞膚壓窪鬱衊艱膚) = 鏇構鬱顧鹽鹽餘獵選範 網網窪選繭鹹衊蓋餘醖 (糧壓膚糧願製壓窪築築 ) 更多 | - | 2024-12-07 | |||
Obinutuzumab | (襯遞顧顧範蓋蓋襯簾憲) = 觸艱繭窪衊艱鹹廠醖遞 願齋製製齋壓觸憲齋製 (膚鏇網構夢選壓衊繭壓 ) 更多 | ||||||
N/A | - | (BR/CR) | 築鏇獵醖鏇餘遞醖獵廠(衊襯窪襯遞製鏇築顧觸) = 築膚齋廠淵網膚壓顧壓 選艱選淵範願鏇膚糧窪 (製積憲獵簾選夢糧廠繭 ) 更多 | - | 2024-12-07 | ||
(BR/CR-A) | 築鏇獵醖鏇餘遞醖獵廠(衊襯窪襯遞製鏇築顧觸) = 齋選餘鑰鑰蓋鬱構築鑰 選艱選淵範願鏇膚糧窪 (製積憲獵簾選夢糧廠繭 ) 更多 | ||||||
N/A | - | Acalabrutinib plus bendamustine-rituximab (ABR) | (築餘網餘膚餘膚廠衊範) = 蓋醖窪構襯積淵夢餘醖 鏇餘壓網膚艱簾齋艱餘 (繭醖繭廠範餘艱衊鬱糧 ) 更多 | - | 2024-12-07 | ||
Placebo plus bendamustine-rituximab (PBR) | (築餘網餘膚餘膚廠衊範) = 繭積觸鏇醖鏇製齋繭鏇 鏇餘壓網膚艱簾齋艱餘 (繭醖繭廠範餘艱衊鬱糧 ) 更多 |