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更新于：2025-07-23
Apalutamide
阿帕他胺
更新于：2025-07-23
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2018-02-14), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、临床急需境外新药 (中国)、优先审评 (澳大利亚) |
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结构/序列
分子式C21H15F4N5O2S |
InChIKeyHJBWBFZLDZWPHF-UHFFFAOYSA-N |
CAS号956104-40-8 |
关联
159
项与 阿帕他胺 相关的临床试验NCT05521698
A Randomized Trial of Apalutamide in Non-Muscle Invasive Bladder Cancer
NCT06592924
A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
NCT06931340
Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)
100 项与 阿帕他胺 相关的临床结果
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100 项与 阿帕他胺 相关的转化医学
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100 项与 阿帕他胺 相关的专利（医药）
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845
项与 阿帕他胺 相关的文献（医药）2025-12-31JOURNAL OF MEDICAL ECONOMICS
Healthcare resource utilization and costs among patients with metastatic castration-sensitive prostate cancer initiated on apalutamide or enzalutamide in the United States (2019–2023)
Article
作者: Khilfeh, Ibrahim ; Bilen, Mehmet A. ; Joshi, Kruti ; Rossi, Carmine ; Du, Shawn ; Shore, Neal D. ; Lowentritt, Benjamin ; Pilon, Dominic ; Wong, Gordon ; Kinkead, Frederic ; Burbage, Sabree
AIMS:
This retrospective longitudinal cohort study compared healthcare resource utilization (HRU) and costs among patients with metastatic castration (hormone)-sensitive prostate cancer who initiated apalutamide or enzalutamide, two androgen receptor pathway inhibitors (ARPIs) that have demonstrated efficacy in the treatment of advanced prostate cancer in phase 3 clinical trials.
METHODS:
Linked patient-level data from a practice-related clinical urology database and an administrative claims database in the United States (1 January 2016-31 December 2023) were used. Per-patient-per-month (PPPM) HRU and cost outcomes were compared between the apalutamide and enzalutamide cohorts during the observation period (i.e. from ARPI initiation until continuous insurance eligibility end) after inverse probability treatment weighting to balance differences in baseline characteristics.
RESULTS:
Overall, 486 patients who initiated apalutamide (mean age 70.3 years, 53.5% white, 25.4% Black, 58.1% Medicare-insured) and 601 patients who initiated enzalutamide (mean age 70.5 years, 52.9% white, 25.5% Black, 58.8% Medicare-insured) were included. Duration of continuous treatment use was 9.6 months for apalutamide and 8.6 months for enzalutamide. Despite longer continuous ARPI use among patients treated with apalutamide relative to enzalutamide, the number of inpatient admissions (rate ratio [RR] = 0.58; 95% confidence interval [CI] = 0.37, 0.86; p = 0.012), number of admission days (RR = 0.58; 95% CI = 0.19, 0.70; p = 0.004), as well as all-cause medical costs (mean monthly cost difference = -$1,845; 95% CI = -$52, -$4,908; p = 0.044) were significantly lower in the apalutamide cohort than the enzalutamide cohort during the observation period. Mean monthly all-cause pharmacy costs between the cohorts was not significantly different ($2,121; 95% CI = -2,389, 5,703; p = 0.320).
LIMITATIONS:
This study relied on administrative claims and clinical data, which may contain coding inaccuracies or omissions. While linkages between the data sources are comprehensive, any mislinkages may have led to misclassification and information bias.
CONCLUSION:
The findings of this study suggest that apalutamide may result in better economic outcomes relative to enzalutamide.
2025-08-01Clinical Genitourinary Cancer
Do Older Patients With Metastatic Hormone-Sensitive Prostate Cancer Benefit From Triplet or Doublet Therapy? A Network Meta-Analysis
Article
作者: Kishi, Noriko ; Alerasool, Parissa ; Tsao, Che-Kai ; Zhou, Susu
INTRODUCTION:
With the expanded approval of androgen receptor axis-targeted (ARAT) agents, clinicians now have more treatment options to offer patients with metastatic hormone-sensitive prostate cancer (mHSPC). Uncertainty remains as to whether older population could benefit similarly from these intensification treatment options.
PATIENTS AND METHODS:
A systematic database search was performed for randomized controlled trials (RCTs) evaluating the efficacy of androgen deprivation therapy (ADT) in combination with ARAT agents and/or docetaxel in older patients (aged ≥ 70 or 75 years) with mHSPC. The primary endpoint was overall survival (OS). Indirect comparisons of available treatment options were estimated using a random-effects network meta-analysis.
RESULTS:
A total of 11 RCTs were eligible. In comparison with ADT alone or ADT + docetaxel doublet, darolutamide + ADT + docetaxel showed a significant OS benefit, with hazard ratios (HRs) of 0.47 (95% confidence interval [CI]: 0.28-0.77) and 0.61 (95% CI, 0.40-0.93), respectively. However, another triplet (abiraterone + ADT + docetaxel) failed to demonstrate a statistically significant OS benefit, with HRs of 0.61 (95% CI, 0.37-1.02) and 0.80 (95% CI, 0.52-1.24), respectively. Triplet therapies comprising darolutamide and abiraterone ranked first and second, with P score of .90 and .67, respectively, followed by darolutamide + ADT (0.61), apalutamide + ADT (0.60), enzalutamide + ADT (0.56), ADT + docetaxel (0.40), abiraterone + ADT (0.20) and ADT alone (0.06). Furthermore, our data suggest an additional benefit from adding docetaxel as a component of doublet and triplet therapies for older men with mHSPC.
CONCLUSION:
In older patients with mHSPC, triplet therapy comprising darolutamide, ADT, and docetaxel demonstrated the most pronounced OS benefit and ranked highest among currently available treatment options. Further studies are needed to explore the specific toxicities associated with the triplet regimen in this population to better balance oncologic benefits with treatment-related toxicities when making treatment decision.
2025-07-17CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
NOVEL ANDROGEN RECEPTOR INHIBITORS IN PROSTATE CANCER: WHAT DO WE KNOW SO FAR?
Review
作者: Rifaldi, Francesca ; Sporeni, Silvio ; Secondino, Simona ; Montagna, Benedetta ; Chiellino, Silvia ; Tortorella, Anna ; Pedrazzoli, Paolo ; Figini, Simone ; Lanzetta, Irene
Prostate cancer (PC) is the second most common cancer among males, following lung cancer, more frequently occurring at an advanced age. Even nowadays, early diagnosis represents a challenge and validated screening methods are still missing. To date, multiple therapeutic strategies are available and a tailored approach is possible. The backbone of PC therapy is represented by the inhibition of the androgen signaling pathway, which mediates tumor cells growth. In this current therapeutic scenario, androgen-receptors signaling inhibitors (ARSIs) play a role in improving cancer treatment. This paper provides an overview of the currently available treatment options, focusing on the new drugs (ARSIs), their actual implications and future developments. METHODS: We conducted a research from Pubmed and Embase database regarding the terms 'prostate cancer', 'ARSI', 'androgen receptor inhibitors', ''enzalutamide", "apalutamide", and "Darolutamide". Original full-text articles published in English were reviewed. Based on this research 185 potentially relevant articles were found, limiting our research to the period 2019-2025 of publication. 75 articles were excluded on the basis of abstract, title or the content.
100 项与 阿帕他胺 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 |
|---|---|---|---|
| 转移性前列腺癌 | 日本 | 2020-05-29 | |
| 转移性去势抵抗性前列腺癌 | 美国 | 2019-09-17 | |
| 激素依赖性前列腺癌 | 欧盟 | 2019-01-14 | |
| 激素依赖性前列腺癌 | 冰岛 | 2019-01-14 | |
| 激素依赖性前列腺癌 | 列支敦士登 | 2019-01-14 | |
| 激素依赖性前列腺癌 | 挪威 | 2019-01-14 | |
| 前列腺癌 | 加拿大 | 2018-07-27 | |
| 去势敏感前列腺癌 | 澳大利亚 | 2018-07-05 | |
| 去势抵抗性前列腺癌 | 美国 | 2018-02-14 |
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 |
|---|---|---|---|---|
| 前列腺腺癌 | 临床3期 | 中国香港 | 2020-07-20 | |
| 复发性前列腺癌 | 临床3期 | 中国香港 | 2020-07-20 | |
| 非转移性前列腺癌 | 临床3期 | 法国 | 2020-01-09 | |
| 阿尔茨海默症 | 临床3期 | 美国 | 2015-12-07 | |
| 阿尔茨海默症 | 临床3期 | 美国 | 2015-12-07 | |
| 阿尔茨海默症 | 临床3期 | 美国 | 2015-12-07 | |
| 阿尔茨海默症 | 临床3期 | 日本 | 2015-12-07 | |
| 阿尔茨海默症 | 临床3期 | 日本 | 2015-12-07 | |
| 阿尔茨海默症 | 临床3期 | 日本 | 2015-12-07 | |
| 阿尔茨海默症 | 临床3期 | 阿根廷 | 2015-12-07 |
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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 | 45 | 餘遞遞築鏇窪鑰繭鏇餘 = 膚餘簾選糧齋廠鑰窪膚 衊觸網選網繭範遞蓋獵 (淵遞憲膚壓積醖築鬱窪, 艱鬱衊鹹鏇繭糧鹹壓網 ~ 遞廠製壓壓製遞鏇鏇築) 更多 | - | 2025-07-03 | |||
N/A | 激素依赖性前列腺癌 PSA kinetics | 129 | Apalutamide plus ADT | 餘築蓋願築願繭鬱構餘(獵繭夢齋獵淵淵獵築觸) = 鑰艱遞築壓膚觸繭夢廠 鹹壓顧遞獵鹽觸構鏇顧 (鏇築鑰鹽夢網糧積齋壓 ) 更多 | 积极 | 2025-05-30 | |
临床2期 | 2 | 醖壓繭鹽築積憲簾鑰艱 = 簾網選構淵夢齋餘網觸 鹹製鑰觸獵鏇壓製選餘 (艱築膚廠夢獵遞鹹築簾, 糧淵觸壓繭簾憲壓願憲 ~ 製齋夢餘艱鹹衊願齋壓) 更多 | - | 2025-05-15 | |||
临床4期 | 75 | Placebo (Placebo Plus Androgen-deprivation Therapy (ADT)) | 夢構顧餘壓憲窪艱醖選(鬱願願積淵糧蓋構簾鹹) = 壓鬱構衊艱簾艱衊鹹餘 構糧憲鏇顧鹽獵襯鹹鑰 (醖膚膚艱鑰窪觸顧願獵, 壓鬱獵淵膚蓋製蓋蓋窪 ~ 鹹鬱範簾繭網醖範簾齋) 更多 | - | 2025-03-28 | ||
(Apalutamide 240 mg Plus ADT) | 夢構顧餘壓憲窪艱醖選(鬱願願積淵糧蓋構簾鹹) = 願積鹽選鹹衊鹹蓋鑰鬱 構糧憲鏇顧鹽獵襯鹹鑰 (醖膚膚艱鑰窪觸顧願獵, 窪鹽積醖廠鹽鬱鹽齋鹹 ~ 醖夢淵糧廠簾壓鑰鏇鏇) 更多 | ||||||
N/A | 1,205 | (Black pts) | - | 积极 | 2025-02-13 | ||
(White pts) | |||||||
临床3期 | 524 | Apalutamide + ADT (With CV/metabolic risk factors at baseline) | 衊遞構選遞糧積襯醖鬱(餘壓獵鹹願鏇製衊網衊): HR = 0.49 (95% CI, 0.38 ~ 0.63), P-Value = <0.0001 更多 | 积极 | 2025-02-13 | ||
Placebo + ADT (With CV/metabolic risk factors at baseline) | |||||||
临床2期 | 174 | Apalutamide+ADT (ARM A: Control) | 積觸淵製艱獵廠鹽膚鹹(壓鏇夢鹽構鹽選獵選網) = 築鹽醖夢壓蓋製窪積鑰 鏇鑰衊製鑰選築繭築壓 (構齋鹽鑰膚壓艱衊襯構 ) | 积极 | 2025-02-13 | ||
Apalutamide+ADT+SBRT (ARM B: Treatment) | 積觸淵製艱獵廠鹽膚鹹(壓鏇夢鹽構鹽選獵選網) = 膚襯衊鑰鹽蓋襯艱鏇齋 鏇鑰衊製鑰選築繭築壓 (構齋鹽鑰膚壓艱衊襯構 ) | ||||||
ASCO_GU2025 人工标引  | N/A | 去势敏感前列腺癌 Prostate specific antigen | 363 | 願艱築膚鑰鹹鑰顧夢壓(鑰積鹽獵觸觸淵齋構簾) = 窪積獵獵觸窪襯繭糧築 鏇選廠窪觸積壓製憲築 (範選壓願簾鏇遞蓋淵夢 ) 更多 | 积极 | 2025-02-13 | |
願艱築膚鑰鹹鑰顧夢壓(鑰積鹽獵觸觸淵齋構簾) = 糧製餘選糧築選製淵遞 鏇選廠窪觸積壓製憲築 (範選壓願簾鏇遞蓋淵夢 ) 更多 | |||||||
临床1期 | 24 | (Part 1) | 襯窪範選願鬱選範蓋範(積築鹽鹹襯積廠願鏇觸) = 蓋鹹網艱遞醖齋鹹蓋鹽 鬱製膚衊襯夢獵淵構衊 (顧網遞齋網鹽鑰窪壓鬱, 3.2) 更多 | 积极 | 2025-02-13 | ||
襯窪範選願鬱選範蓋範(積築鹽鹹襯積廠願鏇觸) = 醖齋糧餘齋選廠繭夢鹽 鬱製膚衊襯夢獵淵構衊 (顧網遞齋網鹽鑰窪壓鬱, 8.0) 更多 | |||||||
N/A | 256 | 願選構繭範顧築淵餘蓋(遞糧餘構顧膚獵淵襯壓) = 鹽繭顧壓選廠憲鏇蓋糧 鬱艱醖憲觸艱艱製鬱簾 (餘鑰網願廠範鏇獵鹹顧, NE ~ NE) | - | 2025-02-13 | |||
願選構繭範顧築淵餘蓋(遞糧餘構顧膚獵淵襯壓) = 蓋艱築醖簾顧鹹選製範 鬱艱醖憲觸艱艱製鬱簾 (餘鑰網願廠範鏇獵鹹顧, 11.6 ~ 19.1) |
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