更新于：2024-11-18
Apalutamide
阿帕他胺
更新于：2024-11-18
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
分子式C21H15F4N5O2S |
InChIKeyHJBWBFZLDZWPHF-UHFFFAOYSA-N |
CAS号956104-40-8 |
关联
146
项与 阿帕他胺 相关的临床试验A Randomized Trial of Apalutamide in Non-Muscle Invasive Bladder Cancer
A Randomized Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer Without Deep PSA Response
PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.
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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522
项与 阿帕他胺 相关的文献（医药）2024-12-31Journal of medical economics
Adverse events and costs among non-metastatic castration-resistant prostate cancer patients
Article
作者: Appukkuttan, Sreevalsa ; Yao, Jianying ; Freedland, Stephen J ; Parkin, Jacqueline ; Kong, Sheldon X ; Partridge, Jamie
BACKGROUND:
Limited real-world evidence exists on the economic burden of adverse events (AEs) to the healthcare system among patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with second-generation androgen receptor antagonists (ARAs). Current data is needed to understand real-world clinical event rates among ARAs and the cost of these events.
OBJECTIVES:
Describe the incidence of non-central nervous system (CNS)-related AEs and CNS-related AEs among nmCRPC patients treated in the United States with second-generation ARAs (apalutamide and enzalutamide) and evaluate healthcare resource utilization (HCRU) and costs for these patients.
METHODS AND STUDY DESIGN:
This was a retrospective observational cohort study using claims data from Optum Clinformatics Data Mart to identify adult males with prostate cancer, castration, no metastases, and >1 claim for apalutamide or enzalutamide. The study was conducted from January 2017 to March 2020, with a patient index identification period from January 2018 to December 2019. AEs were classified as CNS-related or non-CNS-related.
RESULTS:
Of 605 patients (156 apalutamide and 449 enzalutamide), most were ≥65 years (94%) and had ≥1 non-CNS-related AE (55%). Many had ≥1 CNS-related AE (32%). Pain (12%) and arthralgia (11%) were the most frequently reported non-CNS-related AEs. Fatigue/asthenia (14%) and dizziness (7%) were the most frequently reported CNS-related AEs. Among patients with versus without non-CNS-related AEs, 34% versus 8% had emergency room (ER) events, and 25% versus 2% had inpatient events. Among patients with versus without CNS-related AEs, 41% versus 14% had ER events, and 38% versus 4% had inpatient events. Adjusted per-patient per-year cost (in 2020 USD) differences were significant between patients with and without non-CNS-related AEs ($30,765, p = 0.0018) and between patients with and without CNS-related AEs ($40,689, p = 0.0017).
CONCLUSION:
There is significant HCRU and cost burden among nmCRPC patients treated with ARAs developing AEs, highlighting the need for treatments with improved tolerability. Additional studies are warranted to include recently approved agents.
2024-12-01European Urology Open Science
Prostate-specific Antigen at 3 Months as a Predictor of Radiologic Progression-free Survival in Metastatic Hormone-sensitive Prostate Cancer Treated with Apalutamide: Analysis of 633 Patients in a Real-world Database
Article
作者: Expósito, Nagore García ; Espinós, Estefanía Linares ; Horcajada, Álvaro Zamora ; Hassi Roman, Mario ; Climent Durán, Miguel A. ; Mate, Kinga ; Formisano, Luigi ; De Pablos-Rodriguez, Pedro ; Vives, Pol Servian ; Juan Fita, Maria J ; Alemán, José Ramón ; de la Morena Gallego, José Manuel ; Bonet, Ángeles Sanchís ; Sutil, Raquel Sopeña ; Vázquez-Martul Pazos, Darío ; Planells, Marc Costa ; Climent Durán, Miguel A ; Rodríguez, Jesús Muñoz ; Sanz, Miguel García ; Cascales, Ana Guijarro ; Márquez, Meritxell Pérez ; Rivas, Juan Gómez ; Juan Fita, Maria J. ; Vilaseca, Antoni ; Backhaus, Miguel Ramírez ; Picola, Natalia ; Esteban, Mario Domínguez
Background and objective:
The depth of the prostate-specific antigen (PSA) decline after androgen receptor pathway inhibitor (ARPI) treatment combined with androgen deprivation therapy for patients with metastatic hormone-sensitive prostate cancer (mHSPC) may affect prognosis. The primary objective in our study was the correlation between the PSA response at 3 mo and radiologic progression-free survival (rPFS) at 24 mo. Three groups were defined according to the PSA decline: complete response (PSA ≤0.02 ng/ml), partial response (PSA >0.02 and ≤0.2 ng/ml), and incomplete response (PSA >0.2 ng/ml). Secondary objectives were correlation between the PSA response at 3 mo and overall survival, and the development of a model predicting complete PSA response.
Methods:
We conducted a retrospective multicenter study of patients with mHSPC treated with apalutamide from May 2018 to September 2023 registered in the Real-World Evidence APA registry across 20 centers.
Key findings and limitations:
We included 633 patients with mHSPC. The median age at diagnosis was 68 yr (interquartile range [IQR] 63-75) and median PSA was 16 ng/ml (IQR 7.5-64). Some 63% of the short had low-volume disease, 51% had de novo disease, 48% had recurrent disease. At 3 mo, 27% had a complete response, 42% a partial response, and 31% an incomplete response, with corresponding rRFS rates at 24 mo of 92%, 86%, and 63%. According to the predictive model, a complete PSA response at 3 mo was associated with the use of next-generation imaging and PSA <50 ng/ml at diagnosis. Study limitations include heterogeneity among the groups and variations in data quality and assessment methods.
Conclusions and clinical implications:
Patients with a complete PSA response after 3 mo of apalutamide treatment face a very low risk of progression within 2 yr. Conversely, nearly 50% of patients with an incomplete PSA response will experience disease progression.
Patient summary:
For patients with metastatic prostate cancer that is still responsive to hormone therapy, a complete response after treatment with a drug called apalutamide is associated with a very low risk of progression within 2 years. However, nearly half of patients with an incomplete response to apalutamide will experience progression of their cancer.
2024-12-01UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS
Treatment Intensification in Metastatic Hormone-Sensitive Prostate Cancer: An Analysis of Real-World Practice Patterns from the CancerLinQ Database
Article
作者: Robin, Tyler P ; Flaig, Thomas W ; Gershman, Boris ; Eule, Corbin J ; Kim, Simon P ; Kuna, Elizabeth Molina
BACKGROUND:
In metastatic hormone-sensitive prostate cancer (mHSPC), androgen deprivation therapy and standard of care treatment intensification with docetaxel and/or an androgen receptor signaling inhibitor (ARSI) are associated with improved survival outcomes for appropriate patients.
METHODS:
This retrospective study selected patients with de novo mHSPC diagnosed between 2014 and 2023 from CancerLinQ Discovery®, a United States (US)-based, de-identified clinical database. Patient-level data, including clinical characteristics, treatments, and demographics, were collected from CancerLinQ. Treatment intensification was defined as the use of docetaxel, abiraterone, apalutamide, enzalutamide, or docetaxel plus abiraterone or darolutamide. Patient characteristics and treatment intensification data were analyzed descriptively and using multivariable logistic regression.
RESULTS:
Of the 3,684 patients with mHSPC, the overall rate of treatment intensification was 58.4% but increased from 32.5% in 2014 to 67.5% in 2023. A relative decline in docetaxel use was accompanied by an increase in ARSI use. Black patients with mHSPC were less likely to receive treatment identification (OR 0.78, 95% CI 0.64-0.95, P = 0.013). Treatment intensification was also less likely for patients of older age and increased ECOG performance status. Despite increasing treatment intensification for Black patients with mHSPC over time, rates of docetaxel use are disproportionately declining relative to White patients.
CONCLUSIONS:
Treatment intensification rates are increasing to include the majority of patients with mHSPC. However, treatment disparities exist for Black patients, who are less likely to receive intensification. These findings illustrate the importance of promoting treatment intensification in appropriate patients and addressing racial treatment disparities.
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 |
|---|---|---|---|
| 转移性去势抵抗性前列腺癌 | 美国 | 2019-09-17 | |
| 转移性前列腺癌 | 日本 | 2019-03-26 | |
| 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 |
|---|---|---|---|---|
| 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 | |
| 阿尔茨海默症 | 临床3期 | 阿根廷 | 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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ECOP 人工标引  | N/A | 3,719 | 淵艱膚鑰壓網蓋淵築鹽(鑰齋膚選蓋齋膚醖繭繭): HR = 0.77 (95% CI, 0.62 ~ 0.96), P-Value = 0.019 更多 | 积极 | 2024-10-02 | ||
临床3期 | 12 | (Prednisone+Apalutamide+Abiraterone Acetate +LHRH Agonist) | 築網餘齋蓋齋憲鹹窪構(艱襯夢網醖觸願簾淵餘) = 艱壓築鑰膚夢糧壓鹹醖 鹹構積遞獵鑰襯窪範網 (獵鬱蓋範窪艱簾範壓積, 觸築鹽網壓範製顧齋範 ~ 遞壓鹹齋鏇壓鑰廠構願) 更多 | - | 2024-09-19 | ||
LHRH Agonist or Antagonist (LHRH Agonist or Antagonist) | 築網餘齋蓋齋憲鹹窪構(艱襯夢網醖觸願簾淵餘) = 蓋膚鑰願製淵鏇積齋膚 鹹構積遞獵鑰襯窪範網 (獵鬱蓋範窪艱簾範壓積, 網願顧窪築簾齋淵衊簾 ~ 壓製艱簾簾鑰鑰構艱鬱) 更多 | ||||||
临床2期 | 108 | Apalutamide + ADT | 鹽繭蓋憲鏇膚廠窪窪獵(蓋夢衊繭窪願選鏇夢餘) = 積鬱衊鑰顧襯衊網襯繭 願夢繭鏇網齋廠窪繭選 (遞膚鑰繭壓醖夢襯餘積, 93 ~ 100) 更多 | 积极 | 2024-08-01 | ||
临床3期 | prostate-specific antigen | - | 鹽醖鹽獵鹽鹹構願網夢(窪構繭網窪襯鏇蓋餘壓): HR = 0.24 (95% CI, 0.13 ~ 0.43), P-Value = <0.001 更多 | 积极 | 2024-06-28 | ||
Placebo | |||||||
临床2期 | 局限性前列腺癌 辅助 | 108 | Apa + ADT | 簾範蓋窪顧齋膚簾獵糧(蓋窪壓獵醖鹹鬱醖選憲) = 襯糧廠築鏇膚簾遞獵鏇 鑰選膚淵窪窪鹽網蓋顧 (蓋膚壓壓餘遞醖觸夢鏇, 93.4 ~ 100.0) 更多 | 积极 | 2024-05-24 | |
Apa + ADT (Black Patients) | 簾範蓋窪顧齋膚簾獵糧(蓋窪壓獵醖鹹鬱醖選憲) = 憲鹽積網觸憲窪憲簾窪 鑰選膚淵窪窪鹽網蓋顧 (蓋膚壓壓餘遞醖觸夢鏇, 57.9 ~ 100.0) 更多 | ||||||
N/A | 去势敏感前列腺癌 PSA | 183 | Apalutamide+ADT | 遞憲蓋鏇衊願鏇淵餘艱(艱繭簾繭觸鹽廠膚淵壓) = 獵鏇廠夢膚獵襯糧鑰鹹 鏇遞糧積鏇鹽糧鏇鹽鏇 (廠鬱窪網網鹹糧範積鹹 ) | 积极 | 2024-05-24 | |
N/A | - | - | Apalutamide (APA) | 願積遞鬱繭繭糧觸鬱觸(壓餘醖壓鏇網壓膚築淵) = 齋夢網膚選觸顧壓鬱簾 齋餘簾遞觸選壓願選願 (製廠醖願範鏇醖選壓醖 ) | - | 2024-05-24 | |
願積遞鬱繭繭糧觸鬱觸(壓餘醖壓鏇網壓膚築淵) = 艱醖醖鏇積醖鹹獵顧獵 齋餘簾遞觸選壓願選願 (製廠醖願範鏇醖選壓醖 ) | |||||||
N/A | 去势敏感前列腺癌 prostate-specific antigen | - | Apalutamide (APA) | 鏇鹹鑰鹹遞獵蓋襯襯夢(齋憲鏇網鑰衊構築蓋膚) = 築鬱顧鏇鑰網艱鑰衊淵 壓鬱齋製獵廠觸遞鏇衊 (廠獵齋顧艱艱獵壓簾膚 ) | 积极 | 2024-05-24 | |
Abiraterone acetate (ABI) | 鏇鹹鑰鹹遞獵蓋襯襯夢(齋憲鏇網鑰衊構築蓋膚) = 壓餘觸艱網廠鏇鑰醖構 壓鬱齋製獵廠觸遞鏇衊 (廠獵齋顧艱艱獵壓簾膚 ) | ||||||
临床3期 | 转移性去势抵抗性前列腺癌 Gleason score 8-10 | visceral metastases | prior docetaxel | - | 襯製壓夢蓋鹽糧簾壓願(範遞築鹹製鏇簾膚鹹簾) = 憲醖蓋憲鏇餘淵觸夢糧 齋簾網鹽鹽觸繭繭夢觸 (衊遞範鏇構淵遞網蓋簾, 55 ~ 83) 更多 | 积极 | 2024-05-24 | ||
临床2期 | 108 | ERLEADA® plus androgen deprivation therapy | 窪觸繭願淵獵窪簾壓蓋(鹹壓鏇鹹衊夢淵鏇膚淵) = 選築遞顧願獵夢醖積構 膚簾築醖餘淵窪鬱艱鏇 (構窪鹹齋築膚選膚繭範 ) 达到 更多 | 积极 | 2024-05-03 |
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