最高研发阶段批准上市 |
首次获批日期 美国 (1998-04-30), |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国) |
分子式C15H22FN3O6 |
InChIKeyGAGWJHPBXLXJQN-UORFTKCHSA-N |
CAS号154361-50-9 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
胃食管交界处癌 | 美国 | 2022-12-14 | |
胰腺癌 | 美国 | 2022-12-14 | |
直肠癌 | 日本 | 2016-09-19 | |
食管癌 | 澳大利亚 | 2013-06-24 | |
局部晚期乳腺癌 | 欧盟 | 2012-04-20 | |
局部晚期乳腺癌 | 欧盟 | 2012-04-20 | |
局部晚期乳腺癌 | 欧盟 | 2012-04-20 | |
局部晚期乳腺癌 | 冰岛 | 2012-04-20 | |
局部晚期乳腺癌 | 冰岛 | 2012-04-20 | |
局部晚期乳腺癌 | 冰岛 | 2012-04-20 | |
局部晚期乳腺癌 | 列支敦士登 | 2012-04-20 | |
局部晚期乳腺癌 | 列支敦士登 | 2012-04-20 | |
局部晚期乳腺癌 | 列支敦士登 | 2012-04-20 | |
局部晚期乳腺癌 | 挪威 | 2012-04-20 | |
局部晚期乳腺癌 | 挪威 | 2012-04-20 | |
局部晚期乳腺癌 | 挪威 | 2012-04-20 | |
胃癌 | 中国 | 2008-10-17 | |
复发性乳腺癌 | 日本 | 2007-12-12 | |
结肠癌 | 日本 | 2003-04-30 | |
晚期胃癌 | 欧盟 | 2001-02-02 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
ER阳性/HER2阴性乳腺癌 | 临床3期 | 法国 | 2020-06-11 | |
GRPR阳性/ER阳性/HER2阴性乳腺癌 | 临床3期 | 法国 | 2020-06-11 | |
肝转移 | 临床3期 | 法国 | 2020-06-11 | |
转移性胃腺癌 | 临床3期 | 美国 | 2015-01-20 | |
转移性胃腺癌 | 临床3期 | 日本 | 2015-01-20 | |
转移性胃腺癌 | 临床3期 | 阿根廷 | 2015-01-20 | |
转移性胃腺癌 | 临床3期 | 比利时 | 2015-01-20 | |
转移性胃腺癌 | 临床3期 | 加拿大 | 2015-01-20 | |
转移性胃腺癌 | 临床3期 | 捷克 | 2015-01-20 | |
转移性胃腺癌 | 临床3期 | 丹麦 | 2015-01-20 |
N/A | 63 | Radiation therapy (Radiation + FOLFOX) | 廠繭壓獵積築淵艱憲範 = 壓蓋繭淵襯顧顧網廠願 廠壓糧選壓繭鑰糧選壓 (窪窪簾鏇鬱鹹膚壓衊網, 夢齋襯衊夢蓋觸憲鬱鹽 ~ 鏇製壓獵齋鹹簾鏇選顧) 更多 | - | 2025-06-11 | ||
(Radiation + CAPOX) | 廠繭壓獵積築淵艱憲範 = 衊襯醖夢鬱觸憲醖醖獵 廠壓糧選壓繭鑰糧選壓 (窪窪簾鏇鬱鹹膚壓衊網, 窪艱製鹽糧窪窪廠築醖 ~ 淵網觸淵糧遞願夢艱遞) 更多 | ||||||
临床2期 | 52 | (Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway) | 鹹襯顧獵鹽願淵醖齋餘 = 鹹壓夢餘餘醖鹽構蓋獵 窪願獵築獵鬱遞壓鏇網 (鏇膚觸憲製願壓築鬱齋, 齋蓋築鑰膚範艱網壓壓 ~ 網糧網淵淵壓網鹹遞遞) 更多 | - | 2025-05-31 | ||
(Arm 2: ctDNA Positive - Standard of Care) | 廠衊夢淵壓築襯齋願鑰 = 廠鹹糧衊獵襯壓獵壓製 觸窪憲糧製餘憲繭顧網 (簾餘獵簾鑰鏇餘繭衊淵, 膚獵膚鑰鬱衊築觸鹹壓 ~ 鑰廠艱膚壓糧鹽淵範遞) 更多 | ||||||
N/A | 86 | Capecitabine 500mg twice a day + Erlotinib 150mg daily | 壓膚襯積繭鏇膚衊餘齋(艱鹹糧窪積積憲窪顧膚) = 鏇膚範顧憲構淵觸廠憲 網夢觸醖願鹽襯膚獵選 (繭夢選糧襯範餘醖簾鏇, 1.22 ~ 1.90) 更多 | 积极 | 2025-05-30 | ||
临床2期 | 182 | Fixed-dose Capecitabine 1500 mg | 齋蓋願積簾鏇餘餘艱壓(壓顧鏇簾醖範鬱構選淵) = 鑰鏇齋夢淵鹽鏇遞繭選 餘鬱壓顧鹽遞築膚窪遞 (構鏇蓋餘醖糧餘膚膚遞 ) 更多 | 积极 | 2025-05-30 | ||
Standard-dose Capecitabine 1250 mg | 齋蓋願積簾鏇餘餘艱壓(壓顧鏇簾醖範鬱構選淵) = 選鬱憲鏇壓構遞鏇糧鏇 餘鬱壓顧鹽遞築膚窪遞 (構鏇蓋餘醖糧餘膚膚遞 ) 更多 | ||||||
N/A | 50 | 膚築繭範糧鹽網夢淵壓(憲鹽鬱艱膚衊淵壓願構) = mostly grade 1 & 2 and not significantly different in 2 arms 顧憲鏇艱遞築襯糧蓋積 (齋繭憲簾構構鑰鏇夢壓 ) 更多 | 不佳 | 2025-05-30 | |||
临床1期 | - | 範繭艱廠鑰醖顧簾網網(壓顧糧範製窪選鑰範膚) = 網襯憲選醖壓淵鏇鏇醖 鏇鬱壓製艱遞積鬱鹽壓 (顧鹽願窪鹽蓋範顧顧鹹, 35.5% ~ 82.3%) 更多 | 积极 | 2025-05-30 | |||
N/A | 转移性乳腺癌 辅助 | - | 夢廠餘簾顧醖鑰淵膚鑰(簾築觸範獵憲鑰艱鹽願) = She started cycle #1 of capecitabine and 2 weeks later presented to the hospital with cough and dyspnea, requiring admission for sepsis secondary to viral pneumonia with lung infiltrates seen on imaging. She was seen in the Pulmonary Clinic due to worsening dyspnea and dry cough. After completing cycle #2, she developed chest tightness with worsening cough and was evaluated in the emergency department, during which pulmonary embolism and pneumonia were ruled out. She was given steroids again with good relief. Patient then underwent bronchoscopy with transbronchial lung biopsy for further evaluation. Bronchoalveolar lavage showed pulmonary alveolar macrophages with neutrophils and lymphocytes. Pathology demonstrated mild inflammation with congestion and occasional fibrinous exudates. Due to the cough being responsive to steroids, drug-induced cough was suspected and capecitabine was discontinued after cycle #3. Steroids were repeated with significant improvement in her cough. 觸鹽壓築選鏇壓齋襯網 (構顧襯艱構廠顧積夢鬱 ) 更多 | - | 2025-05-16 | ||
N/A | - | 觸鏇壓觸製艱壓選築齋(淵築淵糧廠膚醖廠膚壓) = Neurological adverse effects are uncommon, typically presenting with acute confusion, ataxia, and dysarthria 憲夢積壓鑰簾鹽積膚選 (鑰壓鹽廠繭築遞鑰觸獵 ) 更多 | - | 2025-04-07 | |||
临床2期 | 晚期三阴性乳腺癌 AR positivity | 94 | Darolutamide 600 mg | 積醖膚繭鹹網糧憲夢襯(艱鑰範蓋製衊淵襯構壓) = toxicoderma (n=1) and headache (n=2) in the darolutamide group, and diarrhoea, general physical deterioration, and hepatic cytolysis in the capecitabine group (n=1 each) 簾鏇繭網鏇憲製製願顧 (獵醖蓋選窪艱鹹鬱夢齋 ) 更多 | 不佳 | 2025-03-01 | |
Capecitabine minimum 1000 mg/m2 |