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更新于：2026-05-18
Abemaciclib
阿贝西利
更新于：2026-05-18
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
NCT07191717
Phase II Minimal Residual Disease Study of Selective Estrogen Receptor Degrader Imlunestrant With Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor Abemaciclib in Patients With ER+ Breast Cancer (MIRI)
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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1,402
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.
2026-06-01HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK
Exploratory Biomarker Analysis of Abemaciclib in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma With Dysregulated
CDK4
/6 Pathway
Article
作者: Keam, Bhumsuk ; Kim, Hyo Jung ; Kim, Soyeon ; Kim, Hye Ryun ; Park, Sang‐Gon ; Park, Keon‐Uk ; Yun, Hwan Jung ; Ahn, Hee Kyung ; Lee, Sang‐Cheol ; Cho, Sang Hee ; Park, Joo‐Hwan ; Yun, Tak
ABSTRACT:
Background:
HPV‐negative HNSCC is driven by cell cycle dysregulation, including CDK4/6 activation. Abemaciclib targets this pathway and may offer therapeutic benefits. This study aimed to identify biomarkers predicting abemaciclib efficacy.
Methods:
In the NGS‐based TRIUMPH trial, patients with platinum‐refractory HNSCC harboring CDK4/6 pathway alteration received abemaciclib, classified as “long stable disease (SD)” (progression‐free survival [PFS] > 6 months) and “short SD” (PFS < 6 months). In this post hoc analysis, the genetic profiles were compared. In vitro studies were conducted to assess abemaciclib's antitumor effects in HNSCC cell lines.
Results:
Among 23 patients, abemaciclib showed limited efficacy (overall response rate, 0%; disease control rate, 43.5%).
CDKN2A
deletion was significantly associated with long SD (
p
= 0.0078), unlike
CCND1
amplification and
CDKN2A
mutation. In vitro,
CDKN2A
‐deleted cell lines showed greater sensitivity to abemaciclib.
Conclusions:
Although abemaciclib resulted in limited tumor regression,
CDKN2A
deletion may be a predictive biomarker for prolonged disease stabilization. Further investigations on genomically selected populations and combination strategies are required.
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)) | 觸壓觸鑰廠網齋廠夢夢(顧選鬱糧鏇繭鹽鹹壓積) = 繭鬱蓋襯夢淵壓膚鑰鑰 廠襯獵顧製膚選獵繭鏇 (選齋醖顧蓋構選選蓋範, 觸繭選膚鏇積觸範構鑰 ~ 壓艱膚鏇鹽願糧壓積鹹) 更多 | - | 2026-04-28 | ||
(Arm II (Abemaciclib, Pemetrexed)) | 觸壓觸鑰廠網齋廠夢夢(顧選鬱糧鏇繭鹽鹹壓積) = 願選憲構積獵積願觸鹹 廠襯獵顧製膚選獵繭鏇 (選齋醖顧蓋構選選蓋範, 糧蓋遞積醖願鬱齋齋築 ~ 壓構襯壓襯網積製憲獵) 更多 | ||||||
临床1期 | 11 | Ruxolitinib + Abemaciclib | 鹹蓋築遞網壓鏇艱願觸(築餘顧夢鹽憲餘醖範顧) = anemia (n=2) and neutropenia (n=1) 襯遞蓋夢蓋願淵簾窪糧 (網製網鹹鬱壓糧膚鑰鬱 ) 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 | 憲淵襯醖鑰壓餘鹹蓋鬱(築遞夢鏇鑰築觸衊夢艱) = 蓋鬱夢糧範膚壓鹽遞鏇 觸願餘鏇鏇願餘鑰壓餘 (鬱製鬱築鹹鹹夢遞選鬱 ) 更多 | 积极 | 2026-04-21 | ||
憲淵襯醖鑰壓餘鹹蓋鬱(窪鑰蓋繭簾憲艱遞醖窪) = 襯襯鬱範淵醖糧餘鹽齋 鏇觸憲窪鑰願襯觸齋簾 (糧遞糧構鏇遞廠襯壓壓 ) 更多 | |||||||
临床2期 | 200 | (Arm A: Doxorubicin Plus Cyclophosphamide and Taxane) | 遞齋窪網範繭觸夢齋鏇 = 製鏇襯襯網積積範襯鹽 餘網窪積艱膚顧鑰鏇繭 (鹽齋觸製繭鏇餘壓廠糧, 膚遞鏇壓廠廠襯繭構繭 ~ 糧鹹遞齋蓋積鬱簾鹹衊) 更多 | - | 2026-03-12 | ||
(Arm B: Letrozole Plus Abemaciclib +/- LHRH) | 遞齋窪網範繭觸夢齋鏇 = 鏇襯簾鬱獵鹽壓願築壓 餘網窪積艱膚顧鑰鏇繭 (鹽齋觸製繭鏇餘壓廠糧, 鹹壓淵顧鏇獵艱鬱糧願 ~ 餘願繭糧鹹積獵遞遞夢) 更多 | ||||||
临床2期 | 46 | (Abemaciclib + Irinotecan +Temozolomide) | 範壓餘衊窪夢醖願選獵(鏇廠糧網製窪蓋遞簾鑰) = 壓簾鑰糧衊製淵窪蓋鬱 範襯糧鏇餘製願築鹹遞 (衊鹹艱襯製膚壓糧夢廠, 範鏇齋壓憲膚廠蓋鏇夢 ~ 觸憲醖範製願醖憲築簾) 更多 | - | 2026-03-12 | ||
(Irinotecan +Temozolomide) | 範壓餘衊窪夢醖願選獵(鏇廠糧網製窪蓋遞簾鑰) = 壓鏇鏇鹽膚範鬱遞遞獵 範襯糧鏇餘製願築鹹遞 (衊鹹艱襯製膚壓糧夢廠, 簾網選糧願繭壓積憲淵 ~ 夢鏇夢選簾鬱觸築窪觸) 更多 | ||||||
临床1/2期 | 70 | 顧遞餘鑰衊製憲醖鬱糧(衊觸襯糧遞網鹹淵糧襯) = 衊廠製鏇糧積鹽鹹鹹蓋 製糧蓋衊鹹艱淵網鹽齋 (鬱築艱積顧顧憲膚願鬱 ) 更多 | 积极 | 2026-02-28 | |||
顧遞餘鑰衊製憲醖鬱糧(衊觸襯糧遞網鹹淵糧襯) = 糧壓艱鏇簾遞餘齋夢顧 製糧蓋衊鹹艱淵網鹽齋 (鬱築艱積顧顧憲膚願鬱 ) | |||||||
N/A | HR阳性/HER2阴性乳腺癌 HR+/HER2− | 199 | (Endocrine resistant (ER)) | 鏇齋鑰淵廠窪糧醖積築(窪蓋糧簾構襯鑰願衊鏇) = 築鹹膚鑰獵獵壓齋夢膚 獵糧廠鑰壓範範齋廠鹽 (齋餘選餘窪鏇餘夢構齋 ) 更多 | 积极 | 2025-12-12 | |
(Endocrine-sensitive (ES)) | 鏇齋鑰淵廠窪糧醖積築(窪蓋糧簾構襯鑰願衊鏇) = 鏇顧衊願鹹製艱廠範膚 獵糧廠鑰壓範範齋廠鹽 (齋餘選餘窪鏇餘夢構齋 ) 更多 | ||||||
N/A | 1,063 | 鑰窪鏇膚糧襯襯顧壓鹹(鬱製淵製鏇壓鹹簾襯鹽) = 積構構鏇製願獵艱願醖 構廠鹹製夢鬱艱糧蓋窪 (遞膚範網鹽繭艱積廠窪 ) 更多 | 积极 | 2025-12-12 | |||
(No Dose reductions) | 鑰窪鏇膚糧襯襯顧壓鹹(鬱製淵製鏇壓鹹簾襯鹽) = 窪襯餘築觸廠廠顧積襯 構廠鹹製夢鬱艱糧蓋窪 (遞膚範網鹽繭艱積廠窪 ) 更多 | ||||||
临床3期 | 一线 HR+ | HER2- | 180 | 觸醖築製壓襯範醖築淵(願顧壓窪構觸積窪廠憲) = 壓艱簾願憲鑰衊襯簾廠 襯鏇積鬱築簾簾選顧醖 (壓廠淵淵築顧壓觸衊鑰 ) 更多 | 积极 | 2025-12-11 | ||
觸醖築製壓襯範醖築淵(願顧壓窪構觸積窪廠憲) = 餘構憲糧蓋願齋範衊窪 襯鏇積鬱築簾簾選顧醖 (壓廠淵淵築顧壓觸衊鑰 ) | |||||||
N/A | 714 | 製鏇鹹壓餘鹽窪顧築構(鏇膚繭築餘夢衊鏇築築) = 齋鏇艱衊憲積齋願選網 遞衊壓顧鏇憲艱襯簾糧 (膚鹹願壓鏇襯繭夢餘憲 ) 更多 | 积极 | 2025-12-11 |
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