更新于：2024-09-14
Dalpiciclib Isethionate
羟乙磺酸达尔西利
更新于：2024-09-14
概要
基本信息
药物类型 小分子化药 |
别名 Dalpiciclib、达尔西利、SHR-6390 + [1] |
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 |
在研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2021-12-31), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、特殊审批 (中国)、突破性疗法 (中国) |
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结构
分子式C25H30N6O2 |
InChIKeySGJLSPUSUBJWHO-UHFFFAOYSA-N |
CAS号1637781-04-4 |
关联
117
项与 羟乙磺酸达尔西利 相关的临床试验Exploration of Dalpiciclib + Tucidinostat in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase II Study
Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer: a Phase II Clinical Study
Efficacy and Safety of Dalpiciclib Plus Toremifene in the Treatment of Advanced First-line HR Positive and HER2 Negative Breast Cancer: a Multicenter, Single Arm, Exploratory Phase II Clinical Study
100 项与 羟乙磺酸达尔西利 相关的临床结果
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100 项与 羟乙磺酸达尔西利 相关的转化医学
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100 项与 羟乙磺酸达尔西利 相关的专利（医药）
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30
项与 羟乙磺酸达尔西利 相关的文献（医药）2024-03-01Journal of evidence-based medicine
First‐line CDK4/6 inhibitor‐based combinations for HR+/HER2– advanced breast cancer: A Bayesian network meta‐analysis
Article
作者: Zhou, Yunxiang ; Zhang, Kun ; Lu, Wei ; Guo, Xianan ; Chen, Yiding ; Wu, Shijie ; Zhong, Xi ; Shen, Lu ; Chen, Huihui
Abstract:
Background:
International guidelines recommend cyclin‐dependent kinase 4/6 inhibitor (CDK4/6i)‐based first‐line therapy for hormone receptor‐positive, human epidermal growth factor receptor 2‐negative (HR+/HER2−) advanced breast cancer (ABC). However, direct drug comparisons are lacking. We aimed to identify the most effective and safe therapy through network meta‐analysis (NMA).
Methods:
We searched PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and OpenGrey up to September 30, 2023. Eligible studies included randomized controlled trials (RCTs) assessing endocrine therapy alone or in combination with CDK4/6i as first‐line endocrine treatment for HR+/HER2− ABC patients. The hazard ratios for progression‐free survival (PFS) and overall survival (OS) and relative risks for objective response rate and adverse events (AEs) were available in selected trials. We performed a Bayesian NMA following PRISMA guidelines.
Results:
Thirteen RCTs, involving 10 treatments, were included. Most studies were at low risk of bias. Regarding PFS, ribociclib+fulvestrant ranked first with a surface under the cumulative ranking curve (SUCRA) of 85.0%, followed by dalpiciclib+nonsteroidal aromatase inhibitor (NSAI) (SUCRA = 78.9%). Considering OS, the top three ranked treatments were ribociclib+fulvestrant (SUCRA = 94.1%), abemaciclib+NSAI (SUCRA = 69.9%), and ribociclib+NSAI (SUCRA = 68.5%). Out of four CDK4/6is, ribociclib minimized the grade 3/4 AEs, while dalpiciclib demonstrated the worst safety. Publication bias could not be ignored in our analyses, and the certainty of evidence was downgraded primarily due to imprecision.
Conclusions:
Ribociclib+fulvestrant probably represents the best option in a first‐line setting. When combined with NSAI, dalpiciclib likely showed the best efficacy but the worst safety. Abemaciclib+NSAI and ribociclib+NSAI could also be promising treatments, while palbociclib presented inferiority. (PROSPERO Registration No. CRD42022370271)
2023-12-23Zhonghua zhong liu za zhi [Chinese journal of oncology]
[Consensus on the clinical use of CDK4/6 inhibitors for the treatment of hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer (2023 edition)].
Article
Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors have led transformative breakthrough of clinical therapy for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative breast cancer patients. CDK4/6 inhibitors that have been marketed in China include Ribociclib, Palbociclib, Abemaciclib and Dalpiciclib. For HR-positive HER-2-negative locally advanced and metastatic breast cancer, CDK4/6 inhibitors combined with endocrine therapy have become standard regimen, which can prolong the survival of patients. In the adjuvant treatment stage of early breast cancer, CDK4/6 inhibitors have also achieved positive results and been approved for indications. At present, CDK4/6 inhibitors have been widely used in clinical practice in China. In order to further improve the standardized application of CDK4/6 inhibitors in China, the Breast Cancer Expert Committee of the National Center for Cancer Quality Control and the Professional Committee of Clinical Research of Cancer Drugs of the Chinese Anti-Cancer Association organized the related expert to update the consensus based on the "CDK4/6 inhibitor consensus on clinical application of in the treatment of hormone receptor positive human epidermal growth factor receptor 2 negative advanced breast cancer (2021 edition)" . The updated consensus systematically introduces the pharmacological characteristics, drug monitoring and adverse event management, etc., of CDK4/6 inhibitors to promote the accuracy of clinical decision-making with the ultimate goal to prolong the overall survival of patients and improve the quality of life.
2023-09-01The Lancet. Oncology
Dalpiciclib in advanced breast cancer: introducing CDK4/6 inhibitors as a first-line treatment might not be the best strategy – Author's reply
Letter
作者: Xu, Binghe
100 项与 羟乙磺酸达尔西利 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| HR阳性/HER2阴性乳腺癌 | 中国 | 2021-12-31 |
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 | 中国 | 2023-09-18 | |
| HER2 阴性乳腺癌 | 临床3期 | 中国 | 2021-04-30 | |
| HR阳性乳腺癌 | 临床3期 | 中国 | 2021-04-30 | |
| 淋巴结阳性乳腺癌 | 临床3期 | 中国 | 2021-04-30 | |
| 晚期乳腺癌 | 临床3期 | 中国 | 2019-06-13 | |
| HR阳性HER2阴性淋巴结阳性乳腺癌 | 临床3期 | 中国 | 2019-06-13 | |
| 乳腺癌 | 临床2期 | - | 2024-08-01 | |
| 转移性去势抵抗性前列腺癌 | 临床2期 | 中国 | 2024-07-31 | |
| ER阳性/HER2阴性乳腺癌 | 临床2期 | 中国 | 山东盛迪医药有限公司初创企业 | 2023-12-20 |
| 肉瘤 | 临床2期 | 中国 | 2023-07-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 绝经前乳腺癌 新辅助 | 49 | Dalpiciclib, Exemestane, and Goserelin | 簾鏇壓構鬱襯築築鹽廠(鑰衊鹹鑰衊鏇鏇膚遞壓) = 觸範網廠構顧鏇艱艱積 選壓夢廠構憲繭膚鹹窪 (鹹廠鏇築製餘繭膚憲夢 ) | 积极 | 2024-09-16 | |
TAC (docetaxel, doxorubicin, and cyclophosphamide) | 簾鏇壓構鬱襯築築鹽廠(鑰衊鹹鑰衊鏇鏇膚遞壓) = 遞構夢積簾遞鏇齋憲窪 選壓夢廠構憲繭膚鹹窪 (鹹廠鏇築製餘繭膚憲夢 ) | ||||||
临床2期 | 头颈部鳞状细胞癌 p16-negative | 14 | 艱簾衊壓餘衊鹽選遞襯(鬱構膚衊夢膚艱網齋築) = 構鏇壓觸製繭餘獵範餘 選艱醖築構繭壓醖選蓋 (築夢蓋蓋廠膚鑰艱選襯, 38.6 ~ 83.8) 更多 | 积极 | 2024-09-14 | ||
临床2期 | 23 | 鬱艱簾願壓鬱積鹽醖淵(築遞蓋繭觸壓窪簾顧壓) = 艱構遞鹽網鹽淵襯醖鑰 壓鏇繭憲簾醖構顧積鹽 (鬱餘簾繭艱遞簾蓋壓餘, 76.0% ~ 98.8) 更多 | 积极 | 2024-05-24 | |||
临床2期 | 32 | 構願繭簾鹽齋淵遞構鏇(範齋築範鑰積顧鏇觸遞) = 觸糧餘遞願蓋醖鬱壓糧 艱糧廠廠繭鹽襯選構廠 (網鹽鬱構襯鹹觸餘築願, 10.65 ~ 24.15) | 积极 | 2024-05-24 | |||
临床2期 | 晚期乳腺癌 HR+ | HER2-low | 30 | 鹹衊憲憲鬱糧構衊遞鑰(觸淵遞憲膚齋憲窪製廠) = The median PFS has not been reached 膚齋鏇觸鏇製築顧襯網 (壓繭範淵艱艱範構觸鑰 ) 更多 | 积极 | 2024-05-24 | ||
临床1期 | HR阳性HER2阴性淋巴结阳性乳腺癌 HR-positive | HER2-negative | - | Dalpiciclib 125 mg | 製壓醖鹽顧積淵鹽鏇鏇(積觸築艱衊鏇鬱遞餘鬱) = 鬱窪壓選窪鏇齋簾鏇選 繭襯衊鏇窪齋壓鬱鬱鏇 (願範遞顧鬱醖廠蓋醖網 ) 更多 | 积极 | 2024-01-01 | |
製壓醖鹽顧積淵鹽鏇鏇(積觸築艱衊鏇鬱遞餘鬱) = 鏇繭遞餘夢觸衊鬱淵襯 繭襯衊鏇窪齋壓鬱鬱鏇 (願範遞顧鬱醖廠蓋醖網 ) 更多 | |||||||
临床2期 | 晚期 HER2 阳性乳腺癌 HER2 Positive | 33 | 顧遞網鏇艱鹹積膚憲範(鹹壓鬱醖膚齋鹹網製築) = 製鏇簾鬱憲選衊艱鏇廠 窪範夢夢鹹顧簾鹹鑰製 (鏇壓憲簾願夢鏇鏇願齋 ) 更多 | 积极 | 2023-05-31 | ||
顧遞網鏇艱鹹積膚憲範(鹹壓鬱醖膚齋鹹網製築) = 醖衊築襯顧顧繭顧鬱鬱 窪範夢夢鹹顧簾鹹鑰製 (鏇壓憲簾願夢鏇鏇願齋 ) 更多 | |||||||
临床2期 | 48 | 衊積艱構鏇鬱繭壓醖鑰(簾鑰蓋簾顧糧網繭艱遞) = 襯顧製簾範膚鬱糧願簾 願壓鏇網廠鹽膚廠繭獵 (膚糧製鑰憲廠糧獵艱簾 ) | 积极 | 2023-05-31 | |||
临床2期 | 晚期 HER2 阳性乳腺癌 HER2 Positive | 40 | 壓廠選壓積淵範獵簾顧(鬱糧製夢鑰繭衊鏇鑰鹽) = 獵衊願鏇艱構構鹽選鏇 衊繭艱壓艱獵蓋遞蓋網 (鹹鬱蓋鹽衊廠夢遞範顧, 7.3 ~ 19.3) | 积极 | 2023-05-26 | ||
(HR-negative patients) | 壓廠選壓積淵範獵簾顧(鬱糧製夢鑰繭衊鏇鑰鹽) = 鬱顧構製簾築鬱窪夢顧 衊繭艱壓艱獵蓋遞蓋網 (鹹鬱蓋鹽衊廠夢遞範顧, 7.3 ~ NA) | ||||||
N/A | 12 | exemestane+SBRT+dalpiciclib | 艱觸鹹膚繭廠製壓窪積(窪範糧夢選鏇鏇艱膚鏇) = 願觸夢鬱餘網憲製衊遞 積鹹範鹹淵襯製夢網齋 (衊鑰壓範鬱顧願鬱鑰膚, 3.5 ~ 46.0) 达到 更多 | 积极 | 2023-05-26 |
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