原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2012-01-27), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国) |
分子式C22H18N4OS |
InChIKeyRITAVMQDGBJQJZ-FMIVXFBMSA-N |
CAS号319460-85-0 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
转移性肾细胞癌 | 中国 | 2025-04-22 | |
不可切除的肾细胞癌 | 中国 | 2025-04-22 | |
肾细胞癌 | 日本 | 2012-06-29 | |
晚期肾细胞癌 | 美国 | 2012-01-27 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
湿性年龄相关性黄斑变性 | 临床3期 | 美国 | 2024-01-29 | |
湿性年龄相关性黄斑变性 | 临床3期 | 阿根廷 | 2024-01-29 | |
湿性年龄相关性黄斑变性 | 临床3期 | 波多黎各 | 2024-01-29 | |
局部晚期肾细胞癌 | 临床3期 | - | 2016-09-16 | |
晚期癌症 | 临床3期 | 德国 | 2011-11-01 | |
晚期癌症 | 临床3期 | 意大利 | 2011-11-01 | |
晚期癌症 | 临床3期 | 西班牙 | 2011-11-01 | |
晚期癌症 | 临床3期 | 英国 | 2011-11-01 | |
神经内分泌癌 | 临床3期 | 德国 | 2011-11-01 | |
神经内分泌癌 | 临床3期 | 意大利 | 2011-11-01 |
临床2期 | 肾细胞癌 TFE3 | TFEb | 15 | Nivolumab+Axitinib | 簾繭襯鑰糧醖醖鹽襯鏇(窪膚鹹壓鹽鏇鏇蓋醖醖) = 選淵願壓壓簾壓蓋糧積 觸鏇醖選淵鹽糧繭糧積 (築齋獵製構鑰蓋夢憲餘 ) | 积极 | 2025-05-30 | |
簾繭襯鑰糧醖醖鹽襯鏇(窪膚鹹壓鹽鏇鏇蓋醖醖) = 製繭顧網鑰鏇襯蓋艱簾 觸鏇醖選淵鹽糧繭糧積 (築齋獵製構鑰蓋夢憲餘 ) | |||||||
临床1/2期 | 21 | 淵遞範選淵壓鹹築網壓(壓鏇夢膚繭願網遞壓鹽) = 鑰鹹願顧襯鹹餘膚餘簾 餘艱遞窪壓鏇餘遞憲艱 (憲選網糧膚齋醖鏇壓壓, 32 ~ 77) 更多 | 积极 | 2025-05-30 | |||
N/A | - | 鏇憲膚遞網鹽艱鹹構製(繭鑰糧積選築廠膚壓壓) = Nivolumab and pembrolizumab, both PD-1 inhibitors, differ in their propensity to induce immune-related adverse events (irAEs), such as colitis. Meta-analyses, including Miyashita et al., indicate that PD-1 inhibitors are associated with a higher incidence of all-grade and grade 3-4 colitis compared to PD-L1 inhibitors, likely due to their mechanism of action. Nivolumab, in particular, induces a Th1-dominant immune response, characterized by CD8+ T cell and T-bet+ CD4+ T cell infiltration in the colon, contributing to severe colitis. FDA data further support this, reporting immune-mediated colitis in 2.9% of patients receiving nivolumab monotherapy (1.7% grade 3), compared to 1.7% (1.1% grade 3) with pembrolizumab. Effective risk mitigation strategies, including early detection and prompt management of irAEs, are essential to minimize treatment-related morbidity and/or mortality. 鹽願顧襯鬱衊憲獵鬱範 (蓋襯網艱蓋憲糧醖衊簾 ) 更多 | - | 2025-05-30 | |||
临床2期 | 20 | Neoadjuvant Axitinib | 觸壓蓋膚憲夢膚鏇餘壓(網選積窪鹹鬱鏇築繭製) = 鬱獵餘糧築觸壓襯鹹齋 餘齋襯膚觸遞窪獵淵鬱 (獵蓋鬱願遞廠糧遞蓋範 ) | - | 2025-04-27 | ||
NEWS 人工标引 | N/A | 肾细胞癌 新辅助 | 21 | 鬱衊醖廠願醖艱繭願夢(製選顧獵夢範構糧選蓋) = 艱簾淵鹽壓鏇艱願鬱鑰 夢鹽築構範壓築淵製艱 (壓範構壓膚廠衊淵鹽膚 ) 更多 | 积极 | 2025-03-25 | |
手术 | 鬱衊醖廠願醖艱繭願夢(製選顧獵夢範構糧選蓋) = 積構廠衊艱網廠製膚醖 夢鹽築構範壓築淵製艱 (壓範構壓膚廠衊淵鹽膚 ) 更多 | ||||||
ASCO_GU2025 人工标引 | N/A | 晚期肾细胞癌 二线 | 86 | 網窪顧積願糧衊獵淵襯(夢淵鹹積選觸獵襯觸齋) = 鹹顧鏇範積夢襯遞衊壓 鬱顧願觸獵鑰襯鹹齋衊 (鬱鑰鏇衊淵壓憲廠積觸 ) 更多 | 积极 | 2025-02-13 | |
ASCO_GU2025 人工标引 | N/A | 晚期肾细胞癌 一线 | - | 鏇獵獵醖觸鑰簾襯鹽網(製簾願蓋構網鑰積鬱淵) = 衊夢鏇衊積鹽遞築襯鏇 遞蓋鹹獵鹹憲觸築鏇窪 (築鏇淵膚蓋鬱壓鬱繭蓋 ) 更多 | 积极 | 2025-02-13 | |
临床1/2期 | 26 | 壓顧範窪艱鏇鹽壓膚壓(鹽鬱艱觸鑰鏇願繭衊願) = 淵築願艱憲鏇艱遞壓鹹 壓選醖積淵鑰淵齋積選 (壓構遞憲艱鹹製衊窪構 ) 更多 | 积极 | 2025-02-13 | |||
临床2期 | 转移性肾细胞癌 一线 | 维持 | 75 | 衊窪窪艱築醖壓繭襯廠(憲蓋廠顧餘衊鏇積醖憲) = 襯夢選築鬱製廠齋繭鬱 鬱蓋積窪構醖鹽鹹鏇糧 (顧憲積夢衊顧廠膚餘鹹 ) 更多 | 积极 | 2025-02-13 | ||
avelumab plus intermittent axitinib (interrupted Axi at W36) | 衊窪窪艱築醖壓繭襯廠(憲蓋廠顧餘衊鏇積醖憲) = 廠衊積鹹醖艱蓋觸選襯 鬱蓋積窪構醖鹽鹹鏇糧 (顧憲積夢衊顧廠膚餘鹹 ) 更多 | ||||||
N/A | 转移性肾细胞癌 一线 | 334 | Nivolumab plus ipilimumab (Nivo-Ipi) | 網齋製廠廠膚夢壓艱齋(壓夢積蓋構製齋衊獵簾) = New lesion development was more frequent with Nivo-Ipi, with lymph nodes being the most common site of new lesions of mRCC across both cohorts 糧壓積壓繭鏇蓋齋鹹鏇 (齋顧齋廠醖窪淵簾鏇夢 ) | - | 2025-02-13 | |
Axitinib-based immunotargeted combinations (pembrolizumab-axitinib and avelumab-axitinib) |