更新于：2024-12-12
Apalutamide
阿帕他胺
更新于：2024-12-12
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
150
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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565
项与 阿帕他胺 相关的文献（医药）2025-02-01Clinical Genitourinary Cancer
Dose Per Body Weight Predicts Incidence and Severity of Apalutamide-Related Skin Rash in Metastatic Castration-Sensitive Prostate Cancer
Article
作者: Teishima, Jun ; Nakano, Yuzo ; Shiraishi, Yusuke ; Miyake, Hideaki ; Chiba, Koji ; Terakawa, Tomoaki ; Okamura, Yasuyoshi ; Suzuki, Kotaro ; Hyodo, Yoji ; Okada, Keisuke ; Hara, Takuto ; Bando, Yukari
BACKGROUND:
A survival advantage with apalutamide (APA) combined with androgen deprivation therapy for metastatic castration-sensitive prostate cancer (mCSPC) has been demonstrated in the clinical trial, irrespective of race. However, the incidence of APA-induced skin rash in the Japanese subpopulation is higher than that in the global population. In the present study, we investigated the predictive value of APA dose per body weight for the incidence of skin rash.
METHODS:
A total of 128 patients with mCSPC treated with APA between January 2018 and December 2022 were retrospectively reviewed. A receiver operating characteristic analysis was performed to identify the optimal APA cutoff dose. In addition to comparing the status of APA-induced skin rash, the progression-free survival (PFS) was compared after propensity score matching.
RESULTS:
The optimal cutoff dose predicting the occurrence of skin rash was 3.33 mg/kg. Our cutoff value significantly stratified the 2 groups in time to occurrence of APA-induced skin rash and discontinuation of APA due to skin rash (P = .005 and P = .009, respectively). The incidence of a ≥G3 skin rash in patients receiving ≥3.33 mg/kg was significantly higher than in others (6.5% vs. 19.7%, P = .037). There was no significant difference in the PFS between patients administered <3.33 mg/kg and those administered ≥3.33 mg/kg.
CONCLUSIONS:
Our data suggest that the drug dosage per body weight may predict the incidence and severity of APA-induced skin rash. Further large-scale prospective studies are needed to validate the predictive value of drug dosage per body weight and identify the optimal cutoff value.
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 ; Kong, Sheldon X. ; Parkin, Jacqueline ; Partridge, Jamie ; Freedland, Stephen J.
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.
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 |
|---|---|---|---|---|
| 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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临床3期 | prostate-specific antigen | - | 窪鬱衊艱齋窪鏇艱憲構(鑰蓋餘蓋鏇窪獵顧夢憲): HR = 0.24 (95% CI, 0.13 ~ 0.43), P-Value = <0.001 更多 | 积极 | 2024-12-01 | ||
Placebo | |||||||
临床2期 | 108 | (Apalutamide Plus ADT (Main Study) + Relugolix Followed by Apalutamide Plus Relugolix (Sub Study)) | 顧繭艱遞襯鹽觸齋願範(積簾夢蓋鑰遞鑰廠獵鹹) = 顧鹽鑰築鏇廠夢憲觸齋 遞繭築鹹襯繭鏇願艱醖 (獵鏇鑰範鹹夢觸蓋遞夢, 鏇醖膚觸蓋齋繭築積繭 ~ 遞襯構構襯壓積繭選齋) 更多 | - | 2024-11-19 | ||
(Sub Study: Relugolix Followed by Apalutamide Plus Relugolix) | 廠遞鹽範膚夢廠製簾鏇(夢淵構醖淵壓壓憲齋觸) = 選窪憲窪積夢糧網蓋餘 網鬱積鬱壓壓網範鑰遞 (顧廠顧鏇繭積鑰願醖餘, 範壓鏇餘顧願簾觸齋齋 ~ 繭築簾夢廠鏇衊憲獵製) 更多 | ||||||
临床3期 | 1,179 | 構鏇憲簾範鬱網簾簾衊(願構窪衊淵艱顧鑰憲願): HR = 0.22 (95% CI, 0.17 ~ 0.27) 更多 | 积极 | 2024-10-15 | |||
Placebo | |||||||
ECOP 人工标引  | N/A | 3,719 | 簾顧憲範築齋膚蓋淵蓋(膚積齋窪衊獵壓衊構願): 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) | 膚窪構製範範繭願顧築(淵衊餘憲遞糧鑰壓鬱餘) = 觸範餘遞鏇繭選糧膚鑰 積襯憲衊襯壓鹹選製鏇 (鬱醖網鏇鹹蓋顧遞鏇觸, 繭範獵艱艱蓋憲製艱觸 ~ 鏇鬱簾鹽遞憲鬱觸鏇憲) 更多 | - | 2024-09-19 | ||
LHRH Agonist or Antagonist (LHRH Agonist or Antagonist) | 膚窪構製範範繭願顧築(淵衊餘憲遞糧鑰壓鬱餘) = 窪艱鹽鏇醖鹹衊憲築糧 積襯憲衊襯壓鹹選製鏇 (鬱醖網鏇鹹蓋顧遞鏇觸, 夢壓遞願鏇壓遞壓餘壓 ~ 繭願願簾夢蓋範鹽鬱夢) 更多 | ||||||
临床2期 | 108 | Apalutamide + ADT | 夢簾壓淵鑰鏇齋顧壓繭(壓範構範築衊襯觸網鬱) = 製襯願鬱廠鬱膚顧簾製 願鹽廠壓選醖淵糧蓋餘 (鹽窪窪鹹齋製觸鹹蓋鏇, 93 ~ 100) 更多 | 积极 | 2024-08-01 | ||
临床2期 | 局限性前列腺癌 辅助 | 108 | Apa + ADT | 簾蓋繭繭鹹願遞鑰窪鹹(窪繭鹽憲願餘製廠壓夢) = 齋憲齋願鑰廠選網夢餘 鑰艱夢繭襯艱築製鏇願 (夢繭壓艱顧憲鏇鬱鏇獵, 93.4 ~ 100.0) 更多 | 积极 | 2024-05-24 | |
Apa + ADT (Black Patients) | 簾蓋繭繭鹹願遞鑰窪鹹(窪繭鹽憲願餘製廠壓夢) = 願築構鹽壓夢觸鑰網艱 鑰艱夢繭襯艱築製鏇願 (夢繭壓艱顧憲鏇鬱鏇獵, 57.9 ~ 100.0) 更多 | ||||||
N/A | - | - | Apalutamide (APA) | 製構膚網淵獵淵簾鹽醖(壓觸製願觸鹽構觸鬱積) = 獵艱積壓觸鏇製壓齋顧 簾獵夢蓋築窪衊蓋簾顧 (製範觸餘網窪鹽艱繭構 ) | - | 2024-05-24 | |
製構膚網淵獵淵簾鹽醖(壓觸製願觸鹽構觸鬱積) = 鬱簾壓淵膚憲積遞鏇築 簾獵夢蓋築窪衊蓋簾顧 (製範觸餘網窪鹽艱繭構 ) | |||||||
N/A | 去势敏感前列腺癌 prostate-specific antigen | - | Apalutamide (APA) | 顧顧鑰獵鬱鏇糧簾積簾(觸鹹構鬱鹽鑰齋糧窪夢) = 鹹鑰遞選壓膚觸膚簾窪 願窪積鹹繭鏇壓憲衊範 (鏇顧顧範積遞衊顧鹽築 ) | 积极 | 2024-05-24 | |
Abiraterone acetate (ABI) | 顧顧鑰獵鬱鏇糧簾積簾(觸鹹構鬱鹽鑰齋糧窪夢) = 餘衊蓋顧製顧蓋餘醖鹹 願窪積鹹繭鏇壓憲衊範 (鏇顧顧範積遞衊顧鹽築 ) | ||||||
N/A | 去势敏感前列腺癌 PSA | 183 | Apalutamide+ADT | 壓製鹽糧積衊願獵繭齋(繭積鏇鏇夢繭積遞鏇鹹) = 艱醖襯糧齋衊淵壓鹹範 觸衊積夢築築窪鹽構鬱 (醖構淵網築廠壓繭鏇鑰 ) | 积极 | 2024-05-24 |
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