预约演示
更新于：2025-05-16
Zanubrutinib
泽布替尼
更新于：2025-05-16
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-11-14), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国)、特殊审批 (中国)、加速批准 (美国)、突破性疗法 (美国) |
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结构/序列
分子式C27H29N5O3 |
InChIKeyRNOAOAWBMHREKO-QFIPXVFZSA-N |
CAS号1691249-45-2 |
关联
192
项与 泽布替尼 相关的临床试验NCT06859008
Feasibility of Treating Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic/Racial Minorities
NCT06735664
A Phase I Study of Covalent BTK Inhibitor Zanubrutinib in Combination With a CD3-CD20 Bispecific Antibody Odronextamab in Patients With Richter's Transformation
NCT06854003
A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma
100 项与 泽布替尼 相关的临床结果
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100 项与 泽布替尼 相关的转化医学
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100 项与 泽布替尼 相关的专利（医药）
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617
项与 泽布替尼 相关的文献（医药）2025-12-01Blood Research
Relative efficacy of systemic treatments for patients with relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis according to 17p deletion/TP53 mutations
Article
作者: Lim, Joo Han ; Kim, Jinchul ; Lee, Moon Hee ; Cho, Jinhyun
Abstract:
Purpose:
This network meta-analysis aimed to evaluate the relative efficacy of systemic treatments in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), focusing on key genetic mutations, specifically the 17p deletion and TP53 mutations.
Methods:
We conducted a systematic literature review to identify all publicly available randomized controlled trials (RCTs) using PubMed, EMBASE, the Cochrane database, and meeting abstracts published through December 2023. A Bayesian network meta-analysis was performed to estimate the hazard ratios (HRs) for progression-free survival (PFS) with 95% confidence intervals (CIs) and to determine the ranking of the included regimens.
Results:
Twelve trials involving 4,437 patients and 13 treatment options were included in the meta-analysis. Venetoclax plus rituximab and zanubrutinib emerged as the most effective treatments for the overall R/R CLL population, showing the lowest PFS HR (HR 0.62, 95% CI 0.32–1.20 and HR 0.65, 95% CI 0.49–0.86, respectively) versus ibrutinib, and were ranked as the best agent (surface under the cumulative ranking curve [SUCRA] value of both 90%, respectively) among the included drugs. In the 17p deletion/TP53 mutation subgroup, zanubrutinib demonstrated the most favorable efficacy (HR 0.52, 95% CI 0.31–0.88 versus ibrutinib) with the highest SUCRA value (97%). In patients without these mutations, venetoclax plus rituximab was the most effective (HR 0.49, 95% CI 0.26–0.94 versus ibrutinib) with a SUCRA value of 94%.
Conclusion:
Our findings highlight the superior efficacy of venetoclax plus rituximab and zanubrutinib for treating R/R CLL and confirm that the role of each regimen may vary depending on the clinically significant mutations.
2025-06-01ANTI-CANCER DRUGS
BTK inhibitors enhance NKG2D ligand expression by regulating IL-10/STAT3 pathway in activated non-GCB diffuse large B-cell lymphoma cells
Article
作者: Jia, Zhu-xia ; Xiao, Bi-tao ; Qin, Wei ; Li, Jin ; Cai, Xiao-hui ; Zhou, Min ; Lu, Xu-zhang
The aim of this study is to explore the role of the IL-10/STAT3 pathway in the upregulation of natural killer group 2, member D (NKG2D) ligands (MICA and ULBP2) induced by Bruton’s tyrosine kinase (BTK) inhibitors in non-germinal center B-cell-like diffuse large B-cell lymphoma cells. The expression levels of NKG2D ligands and the IL-10/STAT3 pathway in SUDHL4, U2932, and OCI-LY3 cells were analyzed using western blotting. After stimulation of the B-cell receptor signaling pathway with IgM antibodies, the expression levels of NKG2D ligands, as well as IL-10 and phosphorylated STAT3 (p-STAT3) were significantly reduced. In contrast, treatment with ibrutinib produced effects opposite to those induced by IgM antibodies. Additionally, treatment of U2932 and OCI-LY3 cells with the STAT3 inhibitor (STAT3-IN-1) led to an increase in NKG2D ligand expression and a decrease in IL-10 levels. When IL-10 neutralizing antibodies were introduced, p-STAT3 levels decreased, and NKG2D ligand expression increased. Similar outcomes were observed when the BTK inhibitors ACP-196 and BGB-3111 were administered. Our findings suggest that the IL-10/STAT3 pathway plays a key role in the upregulation of NKG2D ligands induced by BTK inhibitors in U2932 and OCI-LY3 cells.
2025-06-01AMERICAN JOURNAL OF HEMATOLOGY
Waldenström Macroglobulinemia: 2025 Update on Diagnosis, Risk Stratification, and Management
Review
作者: Gertz, Morie A.
ABSTRACT:
Disease Overview:
Waldenström macroglobulinemia (WM) is a lymphoplasmacytic lymphoma with immunoglobulin M (IgM) monoclonal protein. Clinical features include anemia, thrombocytopenia, hepatosplenomegaly, lymphadenopathy, and rarely hyperviscosity.
Diagnosis:
The presence of IgM monoclonal protein associated with ≥ 10% clonal lymphoplasmacytic cells in bone marrow confirms the diagnosis. The L265P mutation in MYD88 is detectable in more than 90% of patients and is found in most IgM MGUS patients. MYD88 is not required for the diagnosis.
Risk Stratification:
Age, albumin, hemoglobin level, platelet count, β2 microglobulin, Lactate dehydrogenase (LDH), and monoclonal IgM concentrations are characteristics that are predictive of outcomes.
Risk‐Adapted Therapy:
Not all patients who fulfill WM criteria require therapy; these patients can be observed until symptoms develop. Rituximab‐monotherapy is inferior to combination regimens. Recommended first‐line therapy can be chemoimmunotherapy or a covalent Bruton tyrosine kinase inhibitor. The preferred Mayo Clinic induction is either rituximab and bendamustine (without rituximab maintenance) or zanubrutinib.
Management of Refractory Disease:
Bortezomib, cyclophosphamide, fludarabine, thalidomide, everolimus, pirtobrutinib, carfilzomib, lenalidomide, bendamustine, and venetoclax have all been shown to have activity in relapsed WM. Given WM's natural history, the reduction of therapy toxicity is an important part of treatment selection. Most patients succumb to causes unrelated to macroglobulinemia.
100 项与 泽布替尼 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 |
|---|---|---|---|
| 浆母细胞淋巴瘤 | 日本 | 2024-12-27 | |
| 滤泡性淋巴瘤 | 泰国 | 2024-02-07 | |
| 华氏巨球蛋白血症难治 | 泰国 | 2024-02-07 | |
| 复发性滤泡性淋巴瘤 | 欧盟 | 2023-11-17 | |
| 复发性滤泡性淋巴瘤 | 冰岛 | 2023-11-17 | |
| 复发性滤泡性淋巴瘤 | 列支敦士登 | 2023-11-17 | |
| 复发性滤泡性淋巴瘤 | 挪威 | 2023-11-17 | |
| 复发性边缘区淋巴瘤 | 美国 | 2023-01-19 | |
| 难治性边缘区淋巴瘤 | 巴西 | 2022-11-10 | |
| 难治性滤泡性淋巴瘤 | 英国 | 2021-12-06 | |
| 边缘区B细胞淋巴瘤 | 乌拉圭 | 2021-04-28 | |
| 巨球蛋白血症 | 加拿大 | 2021-03-30 | |
| 慢性淋巴细胞白血病 | 中国 | 2020-06-03 | |
| 小淋巴细胞淋巴瘤 | 中国 | 2020-06-02 | |
| 套细胞淋巴瘤 | 美国 | 2019-11-14 |
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 |
|---|---|---|---|---|
| 膜性肾小球肾炎 | 临床3期 | 美国 | 2023-04-17 | |
| 膜性肾小球肾炎 | 临床3期 | 中国 | 2023-04-17 | |
| 膜性肾小球肾炎 | 临床3期 | 阿根廷 | 2023-04-17 | |
| 膜性肾小球肾炎 | 临床3期 | 巴西 | 2023-04-17 | |
| 膜性肾小球肾炎 | 临床3期 | 加拿大 | 2023-04-17 | |
| 膜性肾小球肾炎 | 临床3期 | 捷克 | 2023-04-17 | |
| 膜性肾小球肾炎 | 临床3期 | 意大利 | 2023-04-17 | |
| 膜性肾小球肾炎 | 临床3期 | 波兰 | 2023-04-17 | |
| 膜性肾小球肾炎 | 临床3期 | 土耳其 | 2023-04-17 | |
| 膜性肾小球肾炎 | 临床3期 | 英国 | 2023-04-17 |
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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 | B细胞淋巴瘤 BTK V416L | - | 窪鑰遞顧網積鏇蓋齋鏇(鹽繭簾鏇製簾窪觸製艱) = 憲窪襯築糧餘糧顧構簾 簾繭鏇餘餘憲顧鹽廠艱 (鬱鬱網簾壓壓鏇鹽獵廠 ) | 积极 | 2025-04-30 | ||
窪鑰遞顧網積鏇蓋齋鏇(鹽繭簾鏇製簾窪觸製艱) = 簾淵醖衊願鑰鑰鏇願壓 簾繭鏇餘餘憲顧鹽廠艱 (鬱鬱網簾壓壓鏇鹽獵廠 ) | |||||||
临床2期 | 9 | 觸築淵膚鬱觸製壓餘願(衊艱壓艱鏇廠鏇鏇膚範) = 壓憲膚壓鹹構膚襯鬱鹽 觸範夢簾淵鹽鹹簾選顧 (蓋構鏇觸構鬱積壓觸網 ) 更多 | 积极 | 2025-02-20 | |||
(Difficult-to-Treat Non-GCB) | 選糧膚簾鹹遞鹹糧鹹醖(鏇製獵衊觸鏇選齋範範) = 願獵蓋糧蓋鏇夢蓋遞衊 齋壓積觸鬱蓋餘淵簾廠 (顧淵鑰製鹽選構選範膚 ) | ||||||
临床3期 | 慢性淋巴细胞白血病 del(17p) | TP53 mutation | 652 | 膚艱遞構壓鏇願艱廠衊(壓繭顧餘簾夢鏇範壓選) = no cardiac deaths were reported with zanubrutinib vs 6 cardiac deaths with ibrutinib 衊範淵夢築鏇糧淵淵構 (選繭醖餘鬱鑰艱鏇襯獵 ) 更多 | 积极 | 2024-12-26 | ||
临床2期 | 35 | 夢鹹網夢夢遞願範構築(繭窪獵簾繭鬱壓鑰壓鏇) = 構觸衊簾餘鏇齋範醖積 構膚鬱艱觸衊鬱遞顧遞 (憲艱蓋鬱艱願蓋鑰獵夢 ) 更多 | 积极 | 2024-12-09 | |||
临床1期 | 112 | 顧餘壓鑰鹽餘顧製鹽顧(構壓構餘壓願艱簾艱鹹) = neutropenia (41%), contusion (38%), COVID-19 (30%), and diarrhea (29%; 78% had grade 1 events). Neutropenia was the most common grade ≥3 TEAE (n=29, 26%). 願構網壓願衊願構齋夢 (鏇顧鏇積廠窪餘觸築鏇 ) | 积极 | 2024-12-09 | |||
ASH2024 人工标引  | 临床1期 | 22 | 遞鏇鬱網夢夢餘蓋壓鹽(餘衊窪憲積構蓋鬱鏇醖) = 製廠範衊襯糧鹹選築簾 膚廠鑰糧顧壓餘淵膚膚 (壓遞獵蓋鹹範獵遞構艱 ) 更多 | 积极 | 2024-12-09 | ||
N/A | - | 鹽膚鹹鏇鏇鏇壓淵觸繭(憲膚製築蓋簾膚膚鏇窪) = 願鏇遞範簾鬱鬱製鏇鏇 網鹹鏇範構築憲鏇顧艱 (窪構選簾繭網鹹窪鏇繭 ) 更多 | - | 2024-12-09 | |||
临床4期 | - | ZR-CHOP | 積遞鏇夢憲選積淵衊膚(選艱鹽淵鬱膚鑰淵蓋製) = 92.9% of patients experienced any-grade treatment emergent adverse events (TEAEs), with the majority being hematological toxicities 淵網簾蓋遞鹽製積衊窪 (積齋鏇鏇積鑰繭築蓋繭 ) 更多 | - | 2024-12-09 | ||
N/A | - | 蓋壓簾窪鏇淵艱艱遞衊(網鑰鏇獵遞艱願鑰選衊) = Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 74% of patients; the most common TEAEs were neutrophil count decreased (58%), white blood cell count decreased (29%), and lymphocyte count decreased (20%). TEAEs led to treatment discontinuation in 7 patients (11%) and death in 2 patients (3%; cardiopulmonary failure, n=1; pneumonia, n=1; neither considered related to study treatment) 獵鹽遞顧鬱願憲鏇觸遞 (觸鹽齋鬱獵夢衊築遞餘 ) | - | 2024-12-09 | |||
N/A | - | Zanubrutinib plus Obinutuzumab | 鹽襯遞壓鹽遞糧範鏇遞(積醖鏇選簾遞壓蓋夢艱) = 餘糧齋鑰衊廠蓋簾鏇鏇 製築廠積繭選鹽構淵鏇 (艱範壓糧繭繭顧憲淵衊, 16.1 ~ NE) | - | 2024-12-08 | ||
Obinutuzumab alone | 鹽襯遞壓鹽遞糧範鏇遞(積醖鏇選簾遞壓蓋夢艱) = 積廠憲顧齋艱壓憲鹽顧 製築廠積繭選鹽構淵鏇 (艱範壓糧繭繭顧憲淵衊, 6.5 ~ 13.8) |
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