预约演示
更新于：2025-01-23
Tisagenlecleucel
更新于：2025-01-23
概要
基本信息
药物类型 自体CAR-T |
别名 Adoptive immunotherapy agent CTL019、Anti-CD19-CAR transduced T cells、Anti-CD19-chim + [10] |
靶点 |
作用机制 CD19调节剂(B淋巴细胞抗原CD19调节剂)、T淋巴细胞替代物 |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2017-08-30), |
最高研发阶段(中国)临床3期 |
特殊审评优先审评 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先药物（PRIME） (欧盟)、孤儿药 (韩国)、再生医学先进疗法 (美国) |
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结构/序列
Sequence Code 631391916
关联
49
项与 Tisagenlecleucel 相关的临床试验NCT04419909
Retreatment With CTL019/CTL119 in Patients With Late Relapse of B-Cell Lymphomas
NCT06785818
A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea
NCT05541341
Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies: a 15-year Prospective Registry Study on Three Cohorts.
100 项与 Tisagenlecleucel 相关的临床结果
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100 项与 Tisagenlecleucel 相关的转化医学
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100 项与 Tisagenlecleucel 相关的专利（医药）
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627
项与 Tisagenlecleucel 相关的文献（医药）2024-12-31Journal of medical economics
Cost-effectiveness of axicabtagene ciloleucel versus tisagenlecleucel for the treatment of 3L + relapsed/refractory large B-cell lymphoma in the United States: incorporating longer survival results
Article
作者: Davies, Neil ; Locke, Frederick L. ; Bradford, Rory ; Patel, Anik R. ; Ray, Markqayne D. ; Oluwole, Olalekan O. ; Jones, Calum
AIMS:
To provide an update on the cost-effectiveness of the chimeric antigen receptor (CAR) T-cell therapies axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) for the treatment of relapsed/refractory (r/r) large B-cell lymphoma (LBCL) among patients who have previously received ≥2 lines of systemic therapy using more mature clinical trial data cuts (60 months for axi-cel overall survival [OS] and 45 months for tisa-cel OS and progression-free survival [PFS]).
METHODS:
A partitioned survival model consisting of three health states (pre-progression, post-progression and death) was used to estimate quality-adjusted life years (QALYs) and costs associated with axi-cel and tisa-cel over a lifetime horizon. PFS and OS inputs for axi-cel and tisa-cel were based on a previously published matching-adjusted indirect treatment comparison (MAIC). Long-term OS and PFS were extrapolated using parametric survival mixture cure models (PS-MCMs). Costs of CAR-T cell therapy drug acquisition and administration, conditioning chemotherapy, apheresis, CAR T-specific monitoring, stem cell transplant, hospitalization, adverse events, routine care, and terminal care were sourced from US cost databases. Health state utilities were derived from previous publications. Model inputs were varied using a range of sensitivity and scenario analyses.
RESULTS:
Compared with tisa-cel, axi-cel resulted in 2.51 additional QALYs and $50,185 additional costs (an incremental cost-effectiveness ratio [ICER] of $19,994 per QALY gained). In probabilistic sensitivity analysis (PSA), the ICER for axi-cel versus tisa-cel was ≤$50,000/QALY in 99.4% of simulations and ≤$33,500 in 99% of simulations. Axi-cel remained cost-effective versus tisa-cel (assuming a willingness-to-pay threshold of $150,000 per QALY) across a range of scenarios.
CONCLUSIONS:
With longer-term survival data, axi-cel continues to represent a cost-effective option versus tisa-cel for treatment of r/r LBCL among patients who have previously received ≥2 lines of systemic therapy, from a US payer perspective.
2024-12-31JOURNAL OF MEDICAL ECONOMICS
Cost-effectiveness analysis of mosunetuzumab for treatment of relapsed or refractory follicular lymphoma after two or more lines of systemic therapy in the United States
Article
作者: Sanchez Alvarez, Javier ; Lin, Shih-Wen ; Parisé, Hélène ; Di Maio, Danilo ; Zuk, Eric ; Matasar, Matthew ; Shapouri, Sheila ; Kim, Eunice
AIMS:
Mosunetuzumab has received accelerated approval by the US Food and Drug Administration for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. We evaluated the cost-effectiveness of mosunetuzumab for the treatment of R/R FL from a US private payer perspective.
MATERIALS AND METHODS:
A partitioned survival model simulated lifetime costs and outcomes of mosunetuzumab against seven comparators: axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), tazemetostat (taz, EZH2 wild-type only), rituximab plus lenalidomide (R-Len) or bendamustine (R-Benda), obinutuzumab plus bendamustine (O-Benda), and a retrospective real-world cohort (RW) based on current patterns of care derived from US electronic health records (Flatiron Health). Efficacy data for mosunetuzumab were from the pivotal Phase II GO29781 trial (NCT02500407). Relative treatment efficacy was estimated from indirect treatment comparisons (ITCs). Costs included were related to treatment, adverse events, routine care, and terminal care. Except for drug costs (March 2023), all costs were inflated to 2022 US dollars. Costs and quality-adjusted life-years (QALYs) were used to calculate incremental cost-effectiveness ratios (ICERs). Net monetary benefit (NMB) was calculated using a willingness-to-pay (WTP) threshold of $150,000/QALY.
RESULTS:
Mosunetuzumab dominated taz, tisa-cel, and axi-cel with greater QALYs and lower costs. Mosunetuzumab was projected to be cost-effective against R-Benda, O-Benda, and RW with ICERs of $78,607, $42,731, and $21,434, respectively. Mosunetuzumab incurred lower costs but lower QALYs vs. R-Len. NMBs showed that mosunetuzumab was cost-effective against comparators except R-Len.
LIMITATIONS:
Without head-to-head comparative data, the model had to rely on ITCs, some of which were affected by residual bias. Model inputs were obtained from multiple sources. Extensive sensitivity analyses assessed the importance of these uncertainties.
CONCLUSION:
Mosunetuzumab is estimated to be cost-effective compared with approved regimens except R-Len for the treatment of adults with R/R FL.
2024-12-17Cureus Journal of Medical Science
Chimeric Antigen Receptor (CAR) T-cell Therapy in the Treatment of Diffuse Large B-cell Lymphoma (DLBCL): A Systematic Review
Review
作者: Al-Qassab, Zahraa M ; Geddada, Sunitha ; Ibrahiam, Amir T ; Khan, Safeera ; Ullah, Najeeb ; Ahmed, Osman
Chimeric antigen receptor (CAR) T-cell therapy has shown very promising results in the treatment of refractory or relapsed diffuse large B-cell lymphoma (DLBCL). This systematic review evaluates the effectiveness and side effects of CAR T-cell therapies, focusing on factors affecting both clinical outcomes and adverse effects. This review included data from 14 studies involving 1392 patients with DLBCL who underwent CAR T-cell therapy. These studies include both randomized clinical trials and observational studies, which would help to analyze the effectiveness and safety profiles. The review highlights that CAR T-cell therapies, mainly tisagenlecleucel (Tisa-cel) and axicabtagene ciloleucel (Axi-cel), have shown superior effectiveness in comparison to standard chemotherapy in patients with relapsed or refractory DLBCL. Lisocabtagene maraleucel (Liso-cel) showed significant improvement outcomes in event-free and progression-free survival. However, CAR T-cell therapies are associated with many side effects. The most common side effects include hematologic toxicity, prolonged neutropenia, and infections, while clinical outcomes are highly impacted by many factors, which include a pro-inflammatory state, PPM1D gene mutation, infusion timing, and circulating monocytes.
635
项与 Tisagenlecleucel 相关的新闻（医药）2025-01-23
·生物谷
细胞疗法免疫疗法临床结果
2025-01-22
细胞疗法免疫疗法临床2期
2025-01-22
·医药速览
免疫疗法细胞疗法基因疗法
100 项与 Tisagenlecleucel 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Tisagenlecleucel |
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 |
|---|---|---|---|
| 复发性弥漫性大B细胞淋巴瘤 | 韩国 | 2021-03-05 | |
| 难治性弥漫性大 B 细胞淋巴瘤 | 韩国 | 2021-03-05 | |
| 复发性 B 细胞急性淋巴细胞白血病 | 韩国 | 2021-03-05 | |
| 难治性 B 细胞急性淋巴细胞白血病 | 韩国 | 2021-03-05 | |
| 前体B细胞成淋巴细胞白血病淋巴瘤 | 瑞士 | 2018-10-18 | |
| 滤泡性淋巴瘤 | 加拿大 | 2018-09-05 | |
| 急性淋巴细胞白血病 | 欧盟 | 2018-08-23 | |
| 急性淋巴细胞白血病 | 冰岛 | 2018-08-23 | |
| 急性淋巴细胞白血病 | 列支敦士登 | 2018-08-23 | |
| 急性淋巴细胞白血病 | 挪威 | 2018-08-23 | |
| 复发性滤泡性淋巴瘤 | 欧盟 | 2018-08-23 | |
| 复发性滤泡性淋巴瘤 | 冰岛 | 2018-08-23 | |
| 复发性滤泡性淋巴瘤 | 列支敦士登 | 2018-08-23 | |
| 复发性滤泡性淋巴瘤 | 挪威 | 2018-08-23 | |
| 难治性滤泡性淋巴瘤 | 欧盟 | 2018-08-23 | |
| 难治性滤泡性淋巴瘤 | 冰岛 | 2018-08-23 | |
| 难治性滤泡性淋巴瘤 | 列支敦士登 | 2018-08-23 | |
| 难治性滤泡性淋巴瘤 | 挪威 | 2018-08-23 | |
| 大B细胞淋巴瘤 | 美国 | 2018-04-13 | |
| 弥漫性大B细胞淋巴瘤 | 美国 | 2017-08-30 |
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 |
|---|---|---|---|---|
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床3期 | 美国 | 2019-05-07 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床3期 | 美国 | 2019-05-07 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床3期 | 美国 | 2019-05-07 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床3期 | 中国 | 2019-05-07 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床3期 | 日本 | 2019-05-07 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床3期 | 日本 | 2019-05-07 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床3期 | 日本 | 2019-05-07 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床3期 | 澳大利亚 | 2019-05-07 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床3期 | 澳大利亚 | 2019-05-07 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床3期 | 澳大利亚 | 2019-05-07 |
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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
N/A | - | 選構夢齋範範齋顧選夢(鏇鹹糧顧願糧獵夢簾鏇) = 62.5% of pts experienced CRS, no cases of grade ≥3 CRS were reported, median time to CRS onset was 2.0 days (range: 1.0-5.0), 70% of pts who experienced CRS received treatment, all but one received tocilizumab to manage CRS (96.4%), median time to ICANS onset was 5.0 days (range: 1.0-7.0) 餘鏇襯膚網淵鹽夢獵積 (糧膚製顧淵製襯衊鹹觸 ) 更多 | - | 2024-12-09 | |||
ASH2024 人工标引  | N/A | 484 | 遞壓醖夢構廠願醖繭衊(網襯積餘窪鬱獵鹹襯簾) = 鹹醖遞製範壓願襯鬱鑰 顧夢觸餘繭夢獵獵顧壓 (餘窪製積膚淵衊構繭鬱 ) 更多 | 积极 | 2024-12-08 | ||
N/A | - | 鏇鑰繭醖衊觸鏇醖窪積(襯壓齋膚齋艱鏇願鑰繭) = 19 pts have died during the study: 8 due to progressive disease, 10 due to AEs (1 pt each; acute myeloid leukemia, bladder transitional cell carcinoma, cardiac arrest, CRS, encephalitis, gastrointestinal hemorrhage, infection, metastatic squamous cell carcinoma, pneumonia, sepsis), and 1 from euthanasia 憲積製膚鑰膚獵艱鹹獵 (齋積襯繭遞淵簾築顧選 ) 更多 | - | 2024-12-08 | |||
ASH2024 人工标引 | N/A | - | Chimeric Antigen Receptor T-Cell Therapy (aged ≥80) | 餘鹽襯鏇選築糧範繭簾(網憲壓淵繭艱餘餘夢築) = 願鏇淵壓蓋遞艱鬱繭鹹 艱餘窪壓蓋顧製淵鏇製 (壓築淵餘餘遞鑰構醖夢 ) 更多 | 积极 | 2024-12-07 | |
Chimeric Antigen Receptor T-Cell Therapy (aged 65-79) | 餘鹽襯鏇選築糧範繭簾(網憲壓淵繭艱餘餘夢築) = 觸積餘網選範鑰壓廠膚 艱餘窪壓蓋顧製淵鏇製 (壓築淵餘餘遞鑰構醖夢 ) 更多 | ||||||
ESMO2024 人工标引 | N/A | 113 | Tisagenlecleucel (CTL019) | 獵積襯膚鏇膚糧築壓鑰(顧膚衊鑰齋醖鹽齋膚繭) = 餘製範壓繭顧獵衊積選 觸廠艱廠遞齋簾鑰積夢 (構範鏇膚齋積淵鹽構簾 ) 更多 | 积极 | 2024-09-13 | |
N/A | - | 鹽簾蓋淵選齋窪膚觸衊(顧廠製齋艱衊網廠觸艱) = 獵製窪鹹遞糧鑰襯積積 構窪襯窪襯衊憲壓廠鏇 (齋鏇積築蓋網選鹹鹽觸, 61 ~ 71) 更多 | - | 2024-09-04 | |||
N/A | 974 | 齋遞廠願窪獵齋網齋蓋(鹽構願遞齋衊齋網顧簾) = 齋壓壓淵範鹽鏇蓋膚醖 窪觸齋顧範醖築選艱鹽 (遞壓鏇鹽艱製鑰憲窪齋, 61 ~ 71) 更多 | 积极 | 2024-05-24 | |||
N/A | 弥漫性大B细胞淋巴瘤 CD19 | 485 | 遞繭鑰淵遞構醖淵鏇膚(顧構構顧夢廠製網獵觸) = 鬱範顧襯鹽製願築網顧 網餘夢艱構齋齋齋構鑰 (壓範願選窪膚願簾構壓 ) 更多 | 积极 | 2024-05-14 | ||
遞繭鑰淵遞構醖淵鏇膚(顧構構顧夢廠製網獵觸) = 窪衊製膚鏇廠鏇蓋範齋 網餘夢艱構齋齋齋構鑰 (壓範願選窪膚願簾構壓 ) 更多 | |||||||
临床2期 | 滤泡性淋巴瘤 三线 | 97 | Tisagenlecleucel infusion | 獵築鬱鏇壓醖範鬱壓衊(鑰壓齋獵鹹艱糧簾顧鬱) = 鏇鹹鑰鬱遞淵齋淵齋鹽 願衊壓醖簾醖鏇衊餘選 (選願簾製繭網襯襯遞襯, 77.5 ~ 92.4) 更多 | 积极 | 2024-05-14 | |
临床2期 | 115 | (Tisagenlecleucel - Main Cohort) | 膚糧艱齋積淵廠窪壓蓋(遞鏇鹽夢廠顧範範鏇構) = 願範糧窪廠製遞憲窪醖 觸鬱糧壓醖襯積顧淵鹹 (餘壓夢觸糧廠觸繭鹽衊, 鑰範簾淵顧壓壓窪鑰艱 ~ 醖網膚艱構衊夢網範網) 更多 | - | 2024-04-18 | ||
(Tisagenlecleucel - Cohort A) | 顧醖廠獵鹽網膚鹽醖衊(製窪顧衊觸築簾憲遞衊) = 蓋積簾齋糧鏇鏇鹽遞壓 衊鹹壓構選糧餘糧蓋膚 (願窪鑰積糧鏇膚構膚鹹, 窪壓構網餘膚壓鑰遞積 ~ 築鑰積淵築齋淵蓋齋積) 更多 |
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