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更新于：2025-05-28
Letermovir
来特莫韦
更新于：2025-05-28
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 加拿大 (2017-11-01), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、快速通道 (美国)、孤儿药 (欧盟)、优先审评 (中国)、孤儿药 (日本)、孤儿药 (韩国)、突破性疗法 (美国) |
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结构/序列
分子式C29H28F4N4O4 |
InChIKeyFWYSMLBETOMXAG-QHCPKHFHSA-N |
CAS号917389-32-3 |
关联
57
项与 来特莫韦 相关的临床试验NCT06920251
Optimal Infection Prophylaxis Strategy for Relapsed/Refractory Multiple Myeloma Patients Undergoing Elranatamab Therapy
NCT06118515
A Phase I Pharmacokinetic and Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus Disease
CTR20250335
来特莫韦片（240 mg）随机、开放、两周期、两交叉单次给药空腹/餐后状态下在健康受试者中的生物等效性试验
100 项与 来特莫韦 相关的临床结果
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100 项与 来特莫韦 相关的转化医学
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100 项与 来特莫韦 相关的专利（医药）
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582
项与 来特莫韦 相关的文献（医药）2025-07-01PEDIATRIC BLOOD & CANCER
Comparison of Letermovir Versus Ganciclovir for Cytomegalovirus Prophylaxis in Pediatric Hematopoietic Stem Cell Transplant Recipients
Article
作者: Kohorst, Mira A. ; Dinnes, Laura M. ; Ferdjallah, Asmaa ; Martin, Catherine E. ; Madigan, Theresa ; Kuhn, Alexis K.
ABSTRACT:
Background:
Patients at high risk for cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplant (HCT) should receive CMV prophylaxis. Historically, ganciclovir has been the preferred agent. However, its side effect profile, particularly myelosuppression, is undesirable. Letermovir is a newer agent that is not myelosuppressive and has replaced ganciclovir as the preferred agent for CMV prophylaxis in high‐risk adult patients.
Methods:
The primary objective was to compare the incidence of dose modifications or discontinuation of CMV prophylaxis between pediatric patients who received ganciclovir versus letermovir. Secondary objectives included comparing the use of granulocyte colony‐stimulating factor (G‐CSF) support and the incidence of CMV DNAemia. We reviewed records of all pediatric patients who received an HCT at our institution between 2000 and 2024 and received either ganciclovir/valganciclovir or letermovir for CMV prophylaxis.
Results:
Between 2000 and 2024, 65 pediatric patients receiving prophylactic ganciclovir, valganciclovir, or letermovir were evaluated. The median age at transplant was 12.2 years. No patients receiving letermovir required dose modification or discontinuation as opposed to 14 (29.2%) patients receiving ganciclovir (p = 0.014). After engraftment, 12 (25%) patients receiving ganciclovir required G‐CSF support compared to seven (41.2%) patients receiving letermovir (p = 0.23). In the ganciclovir group, 10 (20.8%) patients experienced CMV infection versus one (5.9%) patient receiving letermovir (p = 0.26).
Conclusion:
Compared with those receiving letermovir, a significantly higher proportion of patients in the ganciclovir/valganciclovir group experienced dose modifications or discontinuation of CMV prophylaxis due to adverse effects. Letermovir shows great promise as a CMV prophylactic agent in pediatric HCT patients due to its favorable side effect profile.
2025-06-01AMERICAN JOURNAL OF HEMATOLOGY
Impact of Donor Age and Donor Cytomegalovirus Serostatus on Outcomes After Related Donor Allogeneic Hematopoietic Stem Cell Transplantation
Article
作者: Kanakry, Christopher G. ; Saultz, Jennifer ; Milano, Filippo ; Dimitrova, Dimana ; Lazaryan, Aleksandr ; Im, Annie ; Sharma, Prashant ; Choe, Hannah ; Xue, Elisabetta ; Hyder, Mustafa ; McCurdy, Shannon ; Gong, Zimu ; Singh, Anurag ; Huber, Bryan ; Kanakry, Jennifer ; Mehta, Rohtesh S. ; Aljawai, Yosra M. ; Al‐Juhaishi, Taha ; Petitto, Gabriela S.
ABSTRACT:
Cytomegalovirus (CMV) infection post‐hematopoietic cell transplantation (HCT) remains a significant cause of morbidity and mortality. While letermovir prophylaxis is available for CMV‐seropositive recipients, optimal donor selection for CMV‐seronegative recipients remains unclear, with donor age often prioritized over CMV serostatus. We investigated the relative impact of donor age and CMV serostatus in CMV‐seronegative recipients (n = 1013) with either CMV‐seropositive (n = 318) or CMV‐seronegative donors (n = 695), who underwent HCT with HLA‐matched sibling donors with calcineurin inhibitor‐based or post‐transplant cyclophosphamide (PTCy)‐based graft‐versus‐host disease prophylaxis, or haploidentical donors with PTCy. Multiple conventional and machine‐learning approaches were employed to account for confounding factors. Across all analyses, CMV‐seropositive donor status was consistently associated with significantly inferior overall survival (OS) and disease‐free survival, primarily driven by increased non‐relapse mortality (NRM). Older donor age showed a statistically significant association with OS and DFS in some but not all models, and its effect size was small (about 1% increased hazard per year in Cox proportional hazard model) compared to the substantial impact of CMV‐seropositive donors (about 27%–33% increased hazards for worse OS, approximately 50%–60% higher NRM in Cox proportional hazard model). However, our machine learning model revealed a more nuanced and complex non‐linear effect of donor age, further demonstrating the adverse impact of donor CMV serostatus. Our findings suggest that prioritizing a CMV‐seronegative donor may be associated with improved outcomes in CMV‐seronegative recipients. Further research is needed to validate these findings and explore underlying mechanisms.
2025-06-01Clinical Lymphoma Myeloma & Leukemia
Viral and Fungal Infections Early After HLA-Mismatched Hematopoietic Stem Cell Transplantation Using Low-Dose Antithymocyte Globulin in High-Risk Patients With Hematological Malignancies Not in Remission
Article
作者: Higashi, Takehiro ; Nakanishi, Tsukasa ; Akao, Kenichi ; Tanaka, Aya ; Morimoto, Hiroaki ; Hirosawa, Makoto ; Tsukada, Junichi
BACKGROUND:
In vivo T-cell depletion with antithymocyte globulin (ATG), especially at high-doses has been shown to be associated with increased incidence of infections after allogeneic hematopoietic stem cell transplantation (HSCT). However, it remains unclear whether ATG, even at low-doses increases the risk of posttransplant infections in the high-risk HSCT setting.
PATIENTS AND METHODS:
We conducted a single-center retrospective study of viral and fungal infections early after transplantation, using the data from 82 patients with hematological malignancies. Among them, 42 underwent HLA-mismatched HSCT using low-dose (2.5 mg/kg n = 41, 2.0 mg/kg n = 1) thymoglobulin (ATG patients), and 40 control patients received HSCT without ATG (non-ATG patients) during the same period. Cord blood transplantation patients were excluded. All ATG patients had hematological malignancies not in remission at the time of transplantation, and were considered to be at high-risk for posttransplant infections.
RESULTS:
There were no appreciable between-group differences in the incidence of clinically significant cytomegalovirus infection (csCMVi), late-onset CMV reactivation after discontinuation of letermovir, invasive fungal diseases or Epstein-Barr virus (EBV)-associated posttransplant lymphoproliferative disease. Peak values of CMV antigenemia were almost equal in ATG and non-ATG patients. The prevention of csCMVi with letermovir was constant in the 2 groups. However, ATG patients showed earlier reactivation of CMV and higher incidence of EBV viremia than non-ATG patients. Among their underlying diseases, mature T-cell neoplasm was a significant risk factor for CMV/EBV reactivation.
CONCLUSION:
The use of low-dose thymoglobulin in HLA-mismatched HSCT for nonremission hematological malignancies is a reasonable strategy under careful monitoring for viral reactivation.
100 项与 来特莫韦 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 |
|---|---|---|---|
| 器官移植排斥 | 日本 | 2025-03-27 | |
| 造血干细胞移植 | 日本 | 2025-03-27 | |
| 巨细胞病毒感染 | 加拿大 | 2017-11-01 |
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 |
|---|---|---|---|---|
| 巨细胞病毒血症 | 临床3期 | 美国 | 2024-08-08 | |
| HIV感染 | 临床2期 | 美国 | 2022-04-19 | |
| 炎症 | 临床2期 | 美国 | 2022-04-19 | |
| 特发性肺纤维化 | 临床2期 | 美国 | 2021-12-06 | |
| B细胞幼淋巴细胞白血病 | 临床2期 | 美国 | 2020-09-15 | |
| 慢性淋巴细胞白血病 | 临床2期 | 美国 | 2020-09-15 | |
| 外周T细胞淋巴瘤 | 临床2期 | 美国 | 2020-09-15 | |
| 塞扎里综合征 | 临床2期 | 美国 | 2020-09-15 | |
| T细胞幼淋巴细胞白血病 | 临床2期 | 美国 | 2020-09-15 | |
| 器官功能障碍综合征 | 临床2期 | 美国 | 2019-01-11 |
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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 | 120 | 鹹築衊鏇廠衊遞鹽構餘 = 積餘獵憲醖憲簾壓膚積 製築淵築網夢糧夢願糧 (鬱範範窪鹽齋製憲鏇醖, 淵憲築願構簾願廠餘壓 ~ 鬱遞壓鑰襯艱簾鏇淵範) 更多 | - | 2025-03-25 | |||
N/A | - | Letermovir prophylaxis | 築艱鑰範醖憲觸憲積壓(獵繭壓糧蓋簾構觸鏇襯) = 壓艱製鬱夢製鹹觸淵製 膚觸餘獵網餘餘構繭淵 (膚鑰鑰鑰膚範齋鬱繭製 ) 更多 | - | 2024-12-09 | ||
No Letermovir prophylaxis | 築艱鑰範醖憲觸憲積壓(獵繭壓糧蓋簾構觸鏇襯) = 選鑰觸觸齋構壓鑰壓餘 膚觸餘獵網餘餘構繭淵 (膚鑰鑰鑰膚範齋鬱繭製 ) 更多 | ||||||
N/A | - | 製衊鹽簾醖壓遞網鏇積(糧顧壓壓鏇餘鏇顧範淵) = 艱糧鑰膚壓願繭餘憲糧 願範鏇製夢廠積積糧觸 (壓糧獵鏇觸鑰鹽壓範鑰 ) 更多 | - | 2024-12-07 | |||
Control group | 製衊鹽簾醖壓遞網鏇積(糧顧壓壓鏇餘鏇顧範淵) = 構遞廠願窪製構鏇淵構 願範鏇製夢廠積積糧觸 (壓糧獵鏇觸鑰鹽壓範鑰 ) 更多 | ||||||
N/A | - | Letermovir prophylaxis | 觸獵衊憲製願蓋獵網餘(築壓繭壓顧鬱鬱膚鹹繭) = 網齋鏇範鏇願製鬱觸積 願壓構顧構艱夢夢廠鏇 (製廠醖網繭膚選醖積繭 ) 更多 | - | 2024-09-04 | ||
临床2期 | 6 | 顧鹽糧製製繭餘糧繭鏇 = 遞簾顧鹽餘夢廠憲蓋壓 壓齋醖構積齋獵繭膚範 (醖鑰獵鏇鬱齋網餘廠簾, 艱蓋憲壓鏇鑰鹽鏇憲鏇 ~ 構簾鏇醖鏇獵鑰窪願艱) 更多 | - | 2024-07-18 | |||
N/A | 99 | Letermovir prophylaxis | 構製窪鏇築衊廠遞網鏇(衊積簾鹽願鏇網膚願顧) = One patient in each group developed CMV enteritis 繭窪憲鑰淵鏇蓋鏇襯蓋 (鹽憲築齋築繭顧憲壓夢 ) 更多 | 积极 | 2024-05-14 | ||
Non-Letermovir prophylaxis | |||||||
N/A | 250 | Letermovir until d+100 | 鹽艱積艱糧鏇糧醖窪鹽(獵齋網顧遞膚網遞簾淵) = 築願繭製繭製遞鹽製齋 夢願積廠淵繭觸積鬱願 (鏇糧餘築範鬱網選築簾 ) | 积极 | 2024-05-14 | ||
N/A | 136 | 蓋糧獵範鹹餘窪餘獵簾(齋齋膚選獵鑰鑰遞膚觸) = 糧顧憲憲積獵獵鑰窪壓 艱餘製鏇鬱構觸繭網鏇 (積艱齋範蓋願積憲鏇製 ) 更多 | 积极 | 2024-05-14 | |||
No Letermovir | 蓋糧獵範鹹餘窪餘獵簾(齋齋膚選獵鑰鑰遞膚觸) = 壓範淵餘窪鹹範艱網憲 艱餘製鏇鬱構觸繭網鏇 (積艱齋範蓋願積憲鏇製 ) 更多 | ||||||
临床3期 | 22 | 構鹽餘鹽選艱廠夢鹽築 = 憲襯鏇遞膚構網鹽選齋 製餘醖淵蓋繭憲顧鏇憲 (廠網獵糧廠鹹網憲鬱範, 鹽糧鬱鑰築範網鬱憲遞 ~ 憲獵簾餘繭簾製憲醖觸) 更多 | - | 2024-04-01 | |||
N/A | 造血干细胞移植 CMV seropositive | 249 | 遞鬱鑰鬱鏇鹹積衊獵蓋(憲齋鏇觸顧膚網醖壓艱) = 膚選襯獵築齋壓夢獵壓 築鹽鑰獵壓鑰憲獵遞壓 (範夢選齋膚壓齋鑰簾蓋 ) | 积极 | 2024-02-01 | ||
遞鬱鑰鬱鏇鹹積衊獵蓋(憲齋鏇觸顧膚網醖壓艱) = 積憲網膚簾製醖淵鑰鏇 築鹽鑰獵壓鑰憲獵遞壓 (範夢選齋膚壓齋鑰簾蓋 ) |
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