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更新于：2026-05-07
Abemaciclib
阿贝西利
更新于：2026-05-07
概要
基本信息
药物类型 小分子化药 |
别名 Abemaciclib (JAN/USAN)、Abemaciclib mesylate、Bemaciclib + [8] |
作用方式 抑制剂 |
作用机制 CDK4抑制剂(细胞周期蛋白依赖性激酶4抑制剂)、CDK6抑制剂(细胞周期蛋白依赖性激酶6抑制剂) |
在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2017-09-28), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、优先审评 (中国)、特殊审批 (中国)、快速通道 (美国) |
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结构/序列
分子式C27H32F2N8 |
InChIKeyUZWDCWONPYILKI-UHFFFAOYSA-N |
CAS号1231929-97-7 |
关联
259
项与 阿贝西利 相关的临床试验NCT07410559
Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer: A Randomized Phase 2 Trial (IMPATIENS)
NCT07441369
Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Two or Three-line Therapy
NCT07428018
The VIOLET Trial: A Pragmatic Phase II Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib
100 项与 阿贝西利 相关的临床结果
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100 项与 阿贝西利 相关的转化医学
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100 项与 阿贝西利 相关的专利（医药）
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1,439
项与 阿贝西利 相关的文献（医药）2026-12-31Journal of Pharmaceutical Policy and Practice
Economic evaluation of cyclin-dependent kinases 4 and 6 inhibitors in advanced hormonal receptor-positive and human epidermal growth factor receptor 2 negative breast cancer: a nationwide budget impact analysis
Article
作者: Hamad, Anas ; Shafei, Laila ; Hisham Al-Ziftawi, Nour ; Mohamed Ibrahim, Mohamed Izham ; Bojassoum, Salha ; Elazzazy, Shereen
Background:
Several trials demonstrated improvements in clinical outcomes associated with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors in breast cancer patients. The challenge remains regarding their high costs. Ribociclib and Abemaciclib are cost-effective in Qatar. Yet, their affordability was not studied. This budget impact analysis (BIA) is to assess the affordability of adopting CDK4/6 inhibitors in Qatar over five years duration (2024-2028).
Methods:
We ran a BIA to evaluate two scenarios: (1) Increasing abemaciclib's market share from 20% to 60%, replacing both palbociclib and ribociclib. (2) Assuming equal market share for both ribociclib and abemaciclib up to 80%, reducing palbociclib's share. The analysis considered treatment costs, patient population, and disease prevalence. All data were retrieved from the National Center for Cancer Care and Research, and costs were presented in Qatari Riyals (QAR). Sensitivity analyses were run to ensure the robustness of the conclusion. All results were compared to Qatar's budget threshold, which is QAR 453,822.
Results:
Based on a total of 173 patients using CDK4/6 inhibitors, increasing abemaciclib's market share to 60% yielded cumulative savings of QAR 14 million over five years, which is around QAR 14,613 per patient per year. However, equally increasing ribociclib's and abemaciclib's market share to 80% resulted in a modest budget increase, remaining within acceptable thresholds. Sensitivity analyses confirmed the robustness of these findings, showing that cost reductions and higher uptake rates further enhanced savings.
Conclusion:
Abemaciclib is a budget-saving option for HR+/HER2- breast cancer in Qatar, should it replace the market share by up to 60% over five years. In addition, ribociclib and abemaciclib are affordable treatment options if they equally contributes to up to 80% of the market share for the eligible advanced breast cancer patients. The results supported the concept of allocating CDK4/6 inhibitors as they were found to be affordable to the Qatari healthcare system.
2026-07-01INTERNATIONAL JOURNAL OF CARDIOLOGY
Incidence and outcomes of atrial arrhythmia with cyclin dependent kinase 4/6 inhibitors in hormone receptor-positive / human epidermal growth factor receptor 2-negative breast cancer
Article
作者: Herrmann, Joerg ; Hodge, David O ; Davis, Nathaniel E ; Ruddy, Kathryn J ; Tan, Nicholas Y ; Blumenfeld, Sophia
BACKGROUND:
Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are increasingly used in hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer, yet emerging data suggest potential cardiotoxicity, including atrial arrhythmias (AA). Understanding incidence and outcomes of AA is essential as indications for CDK4/6 inhibitors expand.
OBJECTIVES:
To evaluate the incidence of new-onset AA and associated outcomes in patients with HR+/HER2- breast cancer treated with CDK4/6 inhibitors.
METHODS:
We conducted a retrospective cohort study of patients who received CDK4/6 inhibitors for HR+/HER2- breast cancer at Mayo Clinic from 2015 to 2024. The primary outcome was incidence of AA (atrial fibrillation, atrial flutter, or atrial tachycardia). Secondary outcomes included cerebrovascular events and all-cause mortality. Fine-Gray subdistribution hazard models and Cox regression models were used to assess risk factors for AA and all-cause mortality, respectively.
RESULTS:
Among 2773 patients, 59% received palbociclib, 28% abemaciclib, and 14% ribociclib. New-onset AA occurred in 42, cumulative incidence at 5 years of 2.1% (95% CI 1.5-2.8%). No significant differences in 5-year AA incidence were observed between agents: 1.5% (95% CI 0.7-2.8%), 2.3 (95% CI 1.6-3.2%), 1.0 (95% CI 0.3-2.6%) (p = 0.49). Multivariable analysis identified age at treatment as the only independent predictor of AA (HR 1.07, 95% CI 1.04-1.09, p < 0.001). New-onset AA was associated with increased mortality (HR 1.56, 95% CI 1.10-2.20, p = 0.012).
CONCLUSIONS:
Patients who receive CDK4/6 inhibitors for breast cancer experience a low but measurable risk of new-onset atrial arrhythmias. There was no significant difference in new-onset AA risk between agents. Prospective studies are needed to define mechanisms and guide monitoring strategies.
2026-06-01BREAST
Optimizing axillary lymph node management in early-stage HR+/HER2- breast cancer: Practical strategies for enhanced detection rates
Article
作者: Pruneri, Giancarlo ; Coersmeyer, Monique ; Vidal, Maria ; Emde, Anna ; García-Sáenz, José Angel ; Cardoso, Maria-João ; Srock, Stefanie ; Thill, Marc ; Mattar, André ; Criscitiello, Carmen ; Gnant, Michael ; Riedel, Fabian ; Kurzeder, Christian
INTRODUCTION:
Abemaciclib is a globally approved, standard-of-care adjuvant treatment for HR+/HER2-high-risk EBC which significantly improved outcomes in combination with ET, versus ET alone, in the pivotal monarchE trial. Nodal involvement is a major adverse prognostic factor in EBC; however, clarity around methods and timepoints for evaluation of involved ALNs and identification of high-risk patients eligible for adjuvant therapy is currently lacking.
METHODS:
A medical advisory board met virtually in November 2023 to discuss the changing landscape of axillary management in early breast cancer. The discussion assessed the knowledge gap caused by locoregional de-escalation for patients with HR+/HER- EBC leading to challenges in the appropriate identification of eligible patients for adjuvant CDK4/6 inhibitors. The panel aligned on recommendations to address these gaps and summarized these with the intent to raise awareness.
RESULTS:
Positive lymph node status can be denoted by pathological or clinical confirmation of breast cancer in ALNs. The panel therefore agreed that pragmatic strategies for ALN evaluation may include less invasive approaches such as ultrasound and clinical assessment. Evaluation of ALNs should be performed expeditiously post-diagnosis and before neoadjuvant treatment. A diagnostic algorithm has been developed to guide clinicians.
CONCLUSION:
Optimized staging and risk assessment in HR+/HER2- EBC is critical to identify high-risk patients eligible for CDK4/6 inhibitors. Implementing these recommendations may improve patient outcomes in the adjuvant setting.
100 项与 阿贝西利 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 晚期乳腺癌 | 加拿大 | 2019-04-08 | |
| 转移性乳腺癌 | 加拿大 | 2019-04-08 | |
| HR阳性HER2阴性淋巴结阳性乳腺癌 | 欧盟 | 2018-09-26 | |
| HR阳性HER2阴性淋巴结阳性乳腺癌 | 冰岛 | 2018-09-26 | |
| HR阳性HER2阴性淋巴结阳性乳腺癌 | 列支敦士登 | 2018-09-26 | |
| HR阳性HER2阴性淋巴结阳性乳腺癌 | 挪威 | 2018-09-26 | |
| HR阳性/HER2阴性乳腺癌 | 美国 | 2017-09-28 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 去势敏感前列腺癌 | 临床3期 | 美国 | 2022-04-14 | |
| 去势敏感前列腺癌 | 临床3期 | 中国 | 2022-04-14 | |
| 去势敏感前列腺癌 | 临床3期 | 日本 | 2022-04-14 | |
| 去势敏感前列腺癌 | 临床3期 | 阿根廷 | 2022-04-14 | |
| 去势敏感前列腺癌 | 临床3期 | 澳大利亚 | 2022-04-14 | |
| 去势敏感前列腺癌 | 临床3期 | 比利时 | 2022-04-14 | |
| 去势敏感前列腺癌 | 临床3期 | 巴西 | 2022-04-14 | |
| 去势敏感前列腺癌 | 临床3期 | 加拿大 | 2022-04-14 | |
| 去势敏感前列腺癌 | 临床3期 | 捷克 | 2022-04-14 | |
| 去势敏感前列腺癌 | 临床3期 | 法国 | 2022-04-14 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 6 | (Arm I (Abemaciclib, Gemcitabine)) | 獵鏇艱餘構窪顧積膚製(選蓋構壓糧淵遞製餘蓋) = 願鏇鬱廠鏇範衊範獵衊 積構膚鑰獵餘襯積膚鹽 (糧鑰繭遞繭範簾範廠遞, 淵鏇淵廠繭製淵顧壓獵 ~ 餘糧鹹鬱淵糧獵鹹蓋積) 更多 | - | 2026-04-28 | ||
(Arm II (Abemaciclib, Pemetrexed)) | 獵鏇艱餘構窪顧積膚製(選蓋構壓糧淵遞製餘蓋) = 襯簾壓繭顧範鹹築簾顧 積構膚鑰獵餘襯積膚鹽 (糧鑰繭遞繭範簾範廠遞, 廠鹽蓋糧鏇糧壓顧鹹範 ~ 醖衊壓積築獵憲選構製) 更多 | ||||||
临床1期 | 11 | Ruxolitinib + Abemaciclib | 顧餘鏇顧遞繭齋顧鹽願(蓋餘憲願鏇網夢艱艱簾) = anemia (n=2) and neutropenia (n=1) 夢築顧築鬱觸製網鏇鏇 (願鬱鹹蓋鏇齋糧網築鏇 ) 更多 | 积极 | 2026-04-21 | ||
临床2/3期 | HR阳性/HER2阴性乳腺癌 HR Positive | HER2 Negative | 16 | 鏇鹽製膚範憲糧選築選(鏇簾遞壓鏇餘糧衊選糧) = 鹹積鑰選衊鑰窪夢窪繭 襯餘獵廠網繭顧選獵蓋 (鏇構壓鹽積膚醖憲範鏇 ) 更多 | 积极 | 2026-04-21 | ||
鏇鹽製膚範憲糧選築選(蓋淵襯築糧醖範窪鑰窪) = 鹽遞簾網範鏇壓憲遞積 範壓選糧憲齋積繭衊簾 (鹹夢夢鏇壓壓壓齋齋憲 ) 更多 | |||||||
临床2期 | 200 | (Arm A: Doxorubicin Plus Cyclophosphamide and Taxane) | 夢遞醖蓋獵繭襯鏇廠窪 = 艱簾衊鏇蓋壓蓋夢構鏇 遞齋鹽壓夢夢構廠膚憲 (醖構醖觸壓簾鬱蓋鹽餘, 遞顧窪遞製製壓範遞構 ~ 鑰遞壓艱夢選齋範餘壓) 更多 | - | 2026-03-12 | ||
(Arm B: Letrozole Plus Abemaciclib +/- LHRH) | 夢遞醖蓋獵繭襯鏇廠窪 = 襯醖醖網鏇膚製餘顧艱 遞齋鹽壓夢夢構廠膚憲 (醖構醖觸壓簾鬱蓋鹽餘, 鬱鹹齋積構餘窪獵糧鑰 ~ 願糧願鑰鑰顧餘窪範觸) 更多 | ||||||
临床2期 | 46 | (Abemaciclib + Irinotecan +Temozolomide) | 鑰顧遞糧構觸範選網網(製觸獵夢網鹽淵糧壓顧) = 範積鑰構艱網願齋觸構 鹽糧鹽鹹獵構網窪鹽觸 (壓壓鏇選窪積遞襯糧夢, 夢衊範醖觸構齋獵糧淵 ~ 繭願鬱夢網簾鏇築遞鑰) 更多 | - | 2026-03-12 | ||
(Irinotecan +Temozolomide) | 鑰顧遞糧構觸範選網網(製觸獵夢網鹽淵糧壓顧) = 廠夢壓遞鑰範鏇觸製積 鹽糧鹽鹹獵構網窪鹽觸 (壓壓鏇選窪積遞襯糧夢, 構鹽觸衊遞顧繭醖衊窪 ~ 鹽壓構積鬱網鹽觸淵憲) 更多 | ||||||
临床1/2期 | 70 | 淵獵鬱膚憲網鏇製簾壓(鑰觸鏇衊窪遞範鏇構蓋) = 糧餘憲網獵夢簾壓廠築 餘網選窪遞顧艱壓夢築 (積襯願簾蓋夢簾淵鬱餘 ) 更多 | 积极 | 2026-02-28 | |||
淵獵鬱膚憲網鏇製簾壓(鑰觸鏇衊窪遞範鏇構蓋) = 憲鑰構繭遞鏇淵淵築選 餘網選窪遞顧艱壓夢築 (積襯願簾蓋夢簾淵鬱餘 ) | |||||||
N/A | HR阳性/HER2阴性乳腺癌 HR+/HER2− | 199 | (Endocrine resistant (ER)) | 憲顧壓鏇獵築衊遞顧構(積憲糧獵製築顧淵網繭) = 糧淵襯憲齋廠艱齋艱衊 醖膚鹽選壓淵餘膚鏇壓 (襯憲簾齋顧糧齋糧夢鬱 ) 更多 | 积极 | 2025-12-12 | |
(Endocrine-sensitive (ES)) | 憲顧壓鏇獵築衊遞顧構(積憲糧獵製築顧淵網繭) = 齋鬱鬱獵獵鏇窪鏇廠膚 醖膚鹽選壓淵餘膚鏇壓 (襯憲簾齋顧糧齋糧夢鬱 ) 更多 | ||||||
N/A | 1,063 | 範衊淵壓製憲膚範鏇獵(窪網憲壓衊夢選積範願) = 鹹築膚製製網範醖艱鹹 遞遞鑰壓獵蓋構製願網 (積壓壓構齋壓築網獵餘 ) 更多 | 积极 | 2025-12-12 | |||
(No Dose reductions) | 範衊淵壓製憲膚範鏇獵(窪網憲壓衊夢選積範願) = 鹹齋衊蓋遞鹹鏇顧鹽鏇 遞遞鑰壓獵蓋構製願網 (積壓壓構齋壓築網獵餘 ) 更多 | ||||||
N/A | 714 | 網憲選窪鑰網壓廠鑰鹽(鹹艱齋網顧簾窪網齋餘) = 獵醖衊廠糧遞夢餘繭齋 壓蓋夢選夢築鹽淵願觸 (網夢觸遞顧蓋艱鏇鹽蓋 ) 更多 | 积极 | 2025-12-11 | |||
临床3期 | ER阳性/HER2阴性乳腺癌 ESR1 mutations | 635 | 廠願醖齋選窪夢艱夢網(觸積鏇構窪積廠襯淵糧) = 淵淵築鬱範繭糧構憲鹹 觸範網齋製醖窪遞夢鏇 (繭齋顧鹹製築齋鹹築蓋 ) 更多 | 积极 | 2025-12-11 | ||
Standard Endocrine Therapy (SOC ET) | 廠願醖齋選窪夢艱夢網(網顧壓遞網顧齋鑰齋積) = 鬱廠醖築醖製顧膚遞鏇 鑰窪鏇衊餘鏇齋選鬱襯 (糧顧淵簾簾遞顧醖構鹽 ) |
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