奥妥珠单抗(Obinutuzumab) - 药物靶点：CD20_在研适应症：CD20阳性B细胞慢性淋巴细胞白血病，CD20阳性滤泡性淋巴瘤，滤泡性淋巴瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Afutuzumab、Anti-CD20 monoclonal antibody R7159、Gazyvaro

+ [22]

靶点

CD20

作用机制

CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、ADCC(抗体依赖的细胞毒作用)、CD20定向的溶细胞作用

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [7]

在研适应症

CD20阳性B细胞慢性淋巴细胞白血病CD20阳性滤泡性淋巴瘤滤泡性淋巴瘤+ [46]

非在研适应症

CD20阳性弥漫性大B细胞淋巴瘤CD20阳性血液肿瘤肉芽肿伴多血管炎+ [12]

原研机构

Roche Glycart AG

在研机构

Janssen-Cilag Ltd.F. Hoffmann-La Roche Ltd.Hoffmann-La Roche, Inc.

+ [17]

非在研机构

Hoffmann-La Roche Ltd.Janssen-Cilag GmbH

最高研发阶段批准上市

首次获批日期

美国 (2013-11-01),

慢性淋巴细胞白血病

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)

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结构/序列

Sequence Code 68713L

来源: *****

Sequence Code 9699891H

来源: *****

关联

286

项与奥妥珠单抗相关的临床试验

NCT06806033

/ Recruiting临床2期

A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

The main goal of this trial is to study the frequency and severity of cytokine release syndrome (CRS) in participants with diffuse large B-cell lymphoma (DLBCL) who are using a combination of glofitamab + gemcitabine + oxaliplatin (Glofit-GemOx) followed by glofitamab-only treatment.

开始日期2025-03-31

申办/合作机构

Hoffmann-La Roche, Inc.

NCT06824701

/ Not yet recruiting临床1期IIT

A Phase 1b Study of Tazemetostat in Combination With Zanubrutinib and Anti-CD20 Monoclonal Antibody in Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphomas

The purpose of this clinical trial is to learn if the study drug Tazemetostat combined with Zanubrutinib and anti-CD20 monoclonal antibody is safe and effective in treating patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma.

开始日期2025-03-01

申办/合作机构

University of Utah

[+1]

NCT06649812

/ Not yet recruiting临床2期IIT

A Phase 2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

开始日期2025-02-28

申办/合作机构

National Cancer Institute

100 项与奥妥珠单抗相关的临床结果

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100 项与奥妥珠单抗相关的转化医学

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100 项与奥妥珠单抗相关的专利（医药）

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1,075

项与奥妥珠单抗相关的文献（医药）

2025-03-01·Clinical Lymphoma Myeloma & Leukemia

Measurable Residual Disease Testing Following Nonintensive Chemoimmunotherapy is Predictive of Need for Maintenance Therapy in Previously Untreated Mantle Cell Lymphoma: A Wisconsin Oncology Network Study

Article

作者: Pophali, Priyanka A. ; McQuinn, Danielle ; Rajguru, Saurabh A. ; Kenkre, Vaishalee P. ; Chang, Julie E. ; Mattison, Ryan J. ; Howard, Mitch ; Kim, KyungMann ; Wisinski, Kari B ; Rajguru, Saurabh A ; Hyun, Meredith ; Kenkre, Vaishalee P ; Wassenaar, Tim ; Fletcher, Christopher D ; Endres, Mariah ; Mattison, Ryan J ; Warren, Ruth Callaway ; Fletcher, Christopher D. ; Pophali, Priyanka A ; Wisinski, Kari B. ; Chang, Julie E

INTRODUCTION:

Obinutuzumab is hypothesized to improve progression-free survival (PFS) combined with bendamustine induction in mantle cell lymphoma (MCL). Measurable-residual disease (MRD) testing may predict benefit from maintenance therapy.

METHODS:

Adults (≥ 18 years) with untreated MCL ineligible for intensive therapies received 4 to 6 cycles of bendamustine + obinutuzumab (BO) followed by consolidation obinutuzumab (CO). Restaging after CO included MRD assessment by next-generation sequencing of bone marrow aspirate (BMA) and peripheral blood (PB). Maintenance obinutuzumab (MO) was omitted for patients with imaging complete response (CR) and MRD-negativity in PB/BMA. All other patients received 8 cycles MO. Primary endpoint is PFS; secondary endpoints are response rates, overall survival, and estimation of MRD status.

RESULTS:

Twenty-one patients enrolled, with median age 70 years and stage IV disease in 95%. Twenty patients completed BO; 10 patients received MO per protocol. Six patients did not complete MO due to progression (n = 4), infection (n = 1) and carcinoma (n = 1). Overall response is 95% (75% CR, 20% partial response). Concordance rate between post-consolidation MRD testing in PB and BMA was 70%. After a median follow-up of 43.9 months, median PFS is 46.5 months. The observed difference between 2-year PFS in groups receiving MO versus observation was not statistically significant (HR 0.45, 95% CI, 0.10-1.91). Most common grade 3/4 toxicities were neutropenia, leukopenia, and infections.

CONCLUSIONS:

BO is a tolerable induction regimen with higher rates of CR compared with historical rates with bendamustine + rituximab. Omission of MO did not worsen outcomes in patients achieving MRD-negative status after nonintensive induction/consolidation therapy.

2025-03-01·PEDIATRIC NEPHROLOGY

Obinutuzumab as a viable therapeutic strategy in rituximab-refractory childhood frequently relapsing, steroid-dependent nephrotic syndrome that relapsed during B-cell depletion

Article

作者: Lin, Kyle Ying-kit ; Lin, Kyle Ying-Kit ; Chan, Eugene Yu-hin ; Chan, Eugene Yu-Hin ; Yap, Desmond Yat-hin ; Yap, Desmond Yat-Hin ; Ma, Alison Lap-tak ; Ma, Alison Lap-Tak

Abstract:

A subgroup of children with frequently-relapsing, steroid-dependent nephrotic syndrome relapse during B-cell depletion after rituximab. A 15-year-old boy with focal segmental glomerulosclerosis became rituximab-refractory after 5 courses of treatments, with a relapse-free period shortened to 1 month. Circulating total and memory B-cells were undetectable at the time of relapse. A single infusion of obinutuzumab sustained relapse-free remission up to the last follow-up at 18 months. There was persistent hypogammaglobulinemia but no infection was observed. Obinutuzumab may be a viable option for attaining long-term remission with reasonable side effect profiles in patients who relapse during B-cell depletion after rituximab.

2025-03-01·AMERICAN JOURNAL OF HEMATOLOGY

Chronic Lymphocytic Leukemia: 2025 Update on the Epidemiology, Pathogenesis, Diagnosis, and Therapy

Article

作者: Hallek, Michael

ABSTRACT:

Disease Overview:

Chronic lymphocytic leukemia (CLL) is the most frequent type of leukemia. It typically occurs in older patients and has a highly variable clinical course. Leukemic transformation is initiated by specific genomic alterations that interfere with the regulation of proliferation and apoptosis in clonal B‐cells.

Diagnosis:

The diagnosis is established by blood counts, blood smears, and immunophenotyping of circulating B‐lymphocytes, which identify a clonal B‐cell population carrying the CD5 antigen as well as typical B‐cell markers.

Prognosis and Staging:

Two clinical staging systems, Rai and Binet, provide prognostic information by using the results of physical examination and blood counts. Various biological and genetic markers provide additional prognostic information. Deletions of the short arm of chromosome 17 (del(17p)) and/or mutations of the TP53 gene predict a shorter time to progression with most targeted therapies. The CLL international prognostic index (CLL‐IPI) integrates genetic, biological, and clinical variables to identify distinct risk groups of patients with CLL. The CLL‐IPI retains its significance in the era of targeted agents, but the overall prognosis of CLL patients with high‐risk stages has improved.

Therapy:

Only patients with active or symptomatic disease or with advanced Binet or Rai stages require therapy. When treatment is indicated, several therapeutic options exist: combinations of the BCL2 inhibitor venetoclax with obinutuzumab, or venetoclax with ibrutinib, or monotherapy with one of the inhibitors of Bruton tyrosine kinase (BTK). At relapse, the initial treatment may be repeated if the treatment‐free interval exceeds 3 years. If the leukemia relapses earlier, therapy should be changed using an alternative regimen.

Future Challenges:

Combinations of targeted agents now provide efficient therapies with a fixed duration that generate deep and durable remissions. These fixed‐duration therapies have gained territory in the management of CLL, as they are cost‐effective, avoid the emergence of resistance, and offer treatment free time to the patient. The cure rate of these novel combination regimens is unknown. Moreover, the optimal sequencing of targeted therapies remains to be determined. A medical challenge is to treat patients who are double‐refractory to both BTK and BCL2 inhibitors. These patients need to be treated within experimental protocols using novel drugs.

420

项与奥妥珠单抗相关的新闻（医药）

2025-02-11

·SYNAPSE

2025年2月11日全球新药进展早知道

1. 石药集团「奥马珠单抗」新适应症获批上市 2 月 10 日，石药集团宣布，其附属公司石药集团巨石生物开发的注射用奥马珠单抗生物类似药（商品名：恩益坦）的新适应症已获得 NMPA 批准上市，用于治疗中至重度持续性过敏性哮喘。这是该药在中国获批的第 2 个适应症。恩益坦是石药集团开发的一款人免疫球蛋白 E（IgE）人源化单克隆抗体，为茁乐（罗氏和诺华开发）的生物类似药。此前，恩益坦已于 2024 年 9 月获批上市，用于治疗采用 H1 抗组胺药治疗后仍有症状的成人和青少年（12 岁及以上）慢性自发性荨麻疹患者，是国内首个以生物制品 3.3 类注册分类获批上市的奥马珠单抗生物类似药。 2. 百时美施贵宝CAR-T疗法治疗MZL 2期临床试验成功 2月10日，BMS宣布，评估 Breyanzi®（lisocabtagene maraleucel）用于复发或难治性惰性B细胞非霍奇金淋巴瘤成年患者的2期TRANSCEND FL试验，在边缘区淋巴瘤（MZL）队列中达到其主要终点。结果显示，Breyanzi在这些患者中展现出具有统计学意义及临床意义的总缓解率（ORR）。该研究还达到了完全缓解率（CRR）这一关键次要终点。在顶线分析中，Breyanzi持续展现出持久缓解效果及一致的安全性，未观察到新的安全信号。这项研究标志着Breyanzi在第五种癌症类型中展现出临床意义上的获益，代表其在所有靶向CD19的CAR-T疗法中覆盖B细胞恶性肿瘤类型最广泛，进一步证明了Breyanzi同类最优及疾病领域最优的特性。 3. 局部大面积减脂！创新药CBL-514临床II期成功 2月10日，Caliway生物制药公司宣布其CBL-514第二项2b期研究（CBL-0205）结果达到终点。CBL-514是一种用于大面积局部脂肪减少的在研药物。这项研究是CBL-514在进入3期临床试验前的最后一次2b期研究，结果显示CBL-514在局部脂肪减少方面具有显著疗效。CBL-0205是一项在美国和加拿大15个地点进行的多中心、双盲（参与者和结果评估者）、随机、安慰剂对照的临床研究，研究共招募了173名患有中度（3级）或重度（4级）腹部脂肪堆积的参与者，并使用腹部脂肪评级量表（AFRS）进行评估。每位参与者在腹部皮下接受多达4次研究药物治疗，每次治疗间隔3周，最后一次治疗后进行4周和8周的疗效和安全性随访。MRI数据显示，CBL-514组的54.2%的参与者在最后一次治疗后四周达到至少20%的脂肪体积减少，而安慰剂组为0%。 4. 罗氏CD20单抗「奥妥珠单抗」申报狼疮性肾炎新适应症近日，罗氏公布奥妥珠单抗（obinutuzumab，Gazyva/Gazyvaro）治疗活动性狼疮肾炎患者的III期REGENCY研究的详细分析，并发表于《新英格兰医学杂志》。研究显示，接受奥妥珠单抗+标准疗法（霉酚酸酯和糖皮质激素）治疗的患者有46.4%在76周时实现了完全肾脏缓解（CRR），而接受标准疗法的患者有33.1%达到了CRR（调整后差异为13.4%，95% CI：2.0%-24.8%；P=0.0232）。罗氏在新闻稿中表示，奥妥珠单抗是全球首款在狼疮性肾炎随机III期临床试验中证明完全肾脏缓解（CRR）获益的CD20单抗。根据2024年财报，罗氏已于2024年12月向FDA递交狼疮性肾炎新适应症的上市申请。这意味着，奥妥珠单抗将成为首个获得FDA批准用于治疗狼疮性肾炎的CD20靶向疗法。 5. 科济药业通用型BCMA CAR-T首例受试者四周时评估为sCR 2月10日，科济药业宣布，基于THANK-u Plus™平台开发的通用型BCMA CAR-T，其首例入组患者在第28天访视疗效评估为严格意义上的完全缓解（sCR）和微小残留病（MRD）阴性。该患者为复发/难治性多发性骨髓瘤IgA-λ型（R-ISS分期II期），既往曾经接受过3线联合药物治疗和自体造血干细胞移植，末次治疗后疾病进展入组临床试验。患者接受临床方案中的最低剂量组的CAR-T细胞输注后发生1级CRS，予以退热、托珠单抗治疗后恢复，未见ICANS和其他CAR-T治疗免疫相关不良反应，整体安全性良好。该CAR-T产品计划用于治疗复发/难治性多发性骨髓瘤（R/R MM）或复发/难治性浆细胞白血病（R/R PCL）。公司预估于今年下半年分享更多数据信息。 1. 超1.6亿美元！百奥泰出售一款生物类似药美国市场商业化权益 2 月 10 日，百奥泰宣布已与 Intas Pharmaceuticals 就戈利木单抗生物类似药 BAT2506 签署授权许可及商业化协议。Intas 将拥有 BAT2506 在美国市场的独占商业化权益。该合作总金额最高至 1.645 亿美元。根据协议条款，百奥泰将负责 BAT2506 的研发、生产以及商业化供应，Intas 将通过其美国子公司 Accord BioPharma 负责 BAT2506 在美国市场的商业化。百奥泰可获得总金额最高至 1.645 亿美元，其中包括 2100 万美元首付款、累计不超过 1.435 亿美元里程碑付款，以及净销售额的两位数百分比作为收入分成。内容来源于网络，如有侵权，请联系删除。

上市批准临床成功引进/卖出

2025-02-11

·医药健闻

华润三九收购天士力获批；眼科巨头博士伦出售叫停；西方制药公司正在中国达成更多交易 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态德国医疗保健和技术集团默克公司表示，该公司正在就收购美国癌症和罕见病制药商SpringWorks Therapeutics进行深入谈判。默克公司在声明中说，收购SpringWorks的谈判正在进行中。这家总部位于德国达姆施塔特的公司表示，尚未签署任何具有法律约束力的协议，也不确定交易是否会实现。全球眼科巨头博士伦宣布，在与潜在买家进行接洽后，公司目前没有立即出售的计划。去年10月，外媒报道称著名的投资机构黑石集团和德太投资正考虑联手收购博士伦——出价可能在130亿美元至140亿美元之间。更早之前，去年9月报道，博士伦正在探索一项潜在的出售交易，这可能会使这家全球眼科巨头从其母公司博士康（Bausch Health）分拆出来。目前博士伦已叫停出售的可能性。可穿戴医疗设备公司Kestra Medical Technologies已申请首次公开募股(IPO)，计划融资1亿美元。其IPO定价条款尚未披露，计划在纳斯达克上市。Kestra是一家为高风险心脏骤停患者生产可穿戴式心律转复除颤器的公司。其可穿戴心律转复除颤器系统ASSURE WCD已获得美国食品药品管理局(FDA)批准。天士力发布公告，于2月6日收到华润三九发来通知，华润三九已于近日收到中国华润转发的国务院国资委批复。国务院国资委同意华润三九协议受让天士力、天津和悦科技、天津康顺科技、天津顺祺科技、天津善臻科技、天津通明科技、天津鸿勋科技等7家单位分别持有的35161.9489万股、2917.5350 万股、1250.3722万股、725.2158万股、 646.0255万股、566.8354万股、562.6674万股天士力股份。此次收购事项完成后，天士力控股股东将变更为华润三九，实际控制人将变更为中国华润。恒瑞医药宣布全面推进AI工具，DeepSeek应用并纳入干部考核。同时，通过量化目标和绩效挂钩，可确保技术落地的实效性，避免流于形式。这一文件由董事长孙飘扬下达并签发。不止恒瑞医药，已经有多家药企和医疗保健公司宣布接入DeepSeek，正在掀起新一轮技术风暴。产业动态西方制药公司正在中国达成更多交易，获取用于治疗从肥胖到癌症等各种疾病的“改良型生物疗法”，以利用在中国更快推进的临床试验所产生的早期数据。葛兰素史克(GSK)和阿斯利康(AstraZeneca)等大型医药集团在过去两年里各自都签订了10亿美元以上的协议，买下了在中国以外的地方研发和销售中国药物的权利。与此同时，Forbion、贝恩生命科学(Bain Life Sciences)和泛大西洋投资集团(General Atlantic)等投资机构向新成立的一些生物科技公司投资了数亿美元。礼来公司宣布，与澳大利亚生物技术公司AdvanCell达成合作协议，双方将共同研发用于癌症治疗的阿尔法疗法(Alpha Therapies)。AdvanCell是一家专注于放射性疗法的生物技术公司。根据协议，AdvanCell将提供其Pb-212(铅-212)生产技术及放射性核素开发基础设施，与礼来的在研药物管线结合，推进一系列靶向阿尔法疗法的研发。Pb-212是一种放射性同位素，可用于精准靶向癌细胞，提高疗效的同时降低副作用。康希诺生物研发的婴幼儿用吸附无细胞百（组分）白破联合疫苗（婴幼儿用DTcP）已正式纳入优先审评品种。根据国家优先审评审批的规定，国家药品监督管理局药品审评中心将优先配置资源进行审评。该疫苗为组分百白破疫苗，每种百日咳抗原进行单独纯化，以确定的比例配制，确保产品质量的批间一致性，使产品的质量更加稳定。国家药品监督管理局批准广东东阳光药业股份有限公司申报的1类创新药磷酸萘坦司韦胶囊（商品名：东卫卓），该药适用于与艾考磷布韦片联用，治疗初治或干扰素经治的基因1、2、3、6型成人慢性丙型肝炎病毒（HCV）感染，可合并或不合并代偿性肝硬化。该药品上市为患者提供了新的治疗选择。科济药业宣布，基于THANK-u Plus平台开发的通用型BCMA CAR-T，其首例入组患者在第28天访视疗效评估为严格意义上的完全缓解（sCR）和微小残留病（MRD）阴性。该CAR-T产品计划用于治疗复发/难治性多发性骨髓瘤（R/R MM）或复发/难治性浆细胞白血病（R/R PCL）。公司预估于今年下半年分享更多数据信息。翰森制药公告，基于昕越（伊奈利珠单抗注射液）全球关键性III期试验MITIGATE的积极结果，该产品用于治疗免疫球蛋白G4相关性疾病（IgG4-RD）的新适应症被国家药品监督管理局（NMPA）纳入优先审评审批程序。伊奈利珠单抗是靶向CD19 B细胞消耗性抗体。勃林格殷格翰宣布FIBRONEER-ILD临床试验达到其主要终点，即与安慰剂相比，第52周时患者的用力肺活量（FVC,mL）较基线的绝对变化。FVC是衡量肺功能的指标。FIBRONEER系列试验的初步数据与其特发性肺纤维化（IPF）II期研究的安全性和耐受性数据基本一致，总体不良反应与安慰剂组相当。罗氏旗下基因泰克（Genentech）公司宣布，抗CD20抗体疗法奥妥珠单抗治疗活动性狼疮性肾炎患者的3期临床试验REGENCY的详细分析已发表于《新英格兰医学杂志》。数据显示，奥妥珠单抗与标准治疗联用，达到试验的主要终点，显著提高患者的完全肾脏缓解（CRR）率。该公司正在与包括美国FDA和欧洲药品管理局在内的监管机构分享这些数据。百时美施贵宝宣布，评估Breyanzi药物用于治疗复发难治性惰性B细胞非霍奇金淋巴瘤成人患者的TRANSCEND FL二期试验在边缘区淋巴瘤队列研究中达到了主要终点。该2期试验显示了具有统计学和临床意义的总体缓解率（ORR）。它还达到了完全缓解率（CRR）的关键次要终点，未观察到新的安全性信号。联系美通社 +86-10-5953 9500 info@prnasia.com

并购IPO

2025-02-10

·PMLiVE

Roche announces positive late-stage results for Gazyva/Gazyvaro in lupus nephritis

Roche’s Gazyva/Gazyvaro (obinutuzumab) has demonstrated superiority over standard therapy in patients with active lupus nephritis (LN), according to new late-stage data published in the New England Journal of Medicine . The phase 3 REGENCY trial has been comparing the safety and efficacy of Gazyva/Gazyvaro against placebo, both taken alongside standard therapy mycophenolate mofetil and glucocorticoids in patients with active/chronic proliferative class 3 or 4 LN, with or without class 5. Affecting approximately 1.7 million people worldwide, LN is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys. There is currently no cure for the LN, which mainly impacts women and causes up to a third of patients to progress to end-stage kidney disease within ten years of diagnosis, at which point the only available treatment options are dialysis or transplant. Already approved in 100 countries for various types of lymphoma, Gazyva/Gazyvaro is an intravenously-administered anti-CD20 monoclonal antibody designed to deplete disease-causing B cells that drive persistent inflammation in LN. Results demonstrated that 46.4% of patients randomised to receive Gazyva/Gazyvaro plus standard therapy achieved the study’s primary endpoint of complete renal response (CRR) at week 76, compared to 33.1% of patients receiving standard therapy alone, with this CRR benefit found to be consistent across patient subgroups. Clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation, were also observed for Gazyva/Gazyvaro, and the drug’s safety profile was consistent with the well-characterised profile observed in its haematology-oncology indications. Data from REGENCY is now being shared with health authorities worldwide, including in the US, where it is part of a collaboration between Roche’s Genentech unit and Biogen, and in the EU. Roche’s chief medical officer and head of global product development, Levi Garraway, said: “The fact that nearly half of LN patients achieved a CRR, together with clinically meaningful benefits observed consistently across subgroups, indicates superior disease control with Gazyva/Gazyvaro compared to standard treatment alone. “LN disproportionately affects younger women, mostly women of colour, often leading to end-stage kidney disease. Our goal is to address this urgent need by providing a more effective treatment option.”

临床结果临床3期上市批准

100 项与奥妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09321	奥妥珠单抗	L01XC15	DB08935

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
CD20阳性B细胞慢性淋巴细胞白血病	日本	Chugai Pharmaceutical Co., Ltd.	2022-12-23
CD20阳性滤泡性淋巴瘤	日本	Nippon Shinyaku Co., Ltd.	2018-07-02
CD20阳性滤泡性淋巴瘤	日本	Chugai Pharmaceutical Co., Ltd.	2018-07-02
滤泡性淋巴瘤	澳大利亚	F. Hoffmann-La Roche Ltd.	2014-05-15
慢性淋巴细胞白血病	美国	Genentech, Inc.	2013-11-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
边缘区B细胞淋巴瘤	申请上市	中国	F. Hoffmann-La Roche Ltd.	2019-09-28
肿瘤溶解综合征	临床3期	美国	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	法国	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	希腊	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	波多黎各	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	塞尔维亚	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	西班牙	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	中国台湾	AbbVie, Inc.	2024-08-05
先天性肾病	临床3期	美国	F. Hoffmann-La Roche Ltd.	2023-03-29
先天性肾病	临床3期	中国	F. Hoffmann-La Roche Ltd.	2023-03-29

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04221477 (REGENCY, Literature \| BusinessWire) 人工标引	临床3期	狼疮性肾炎	271	obinutuzumab + standard therapy	觸製網構廠衊鏇餘壓獵(遞鑰遞艱餘廠簾築鹹製) = 窪繭範醖積窪艱獵衊願遞壓艱觸願鹽簾繭夢艱 (網醖膚糧膚觸範構襯衊 ) 更多	积极	2025-02-07
				placebo + standard therapy	觸製網構廠衊鏇餘壓獵(遞鑰遞艱餘廠簾築鹹製) = 襯網選窪鏇顧遞範築遞遞壓艱觸願鹽簾繭夢艱 (網醖膚糧膚觸範構襯衊 ) 更多
ASH2024 人工标引	N/A	慢性淋巴细胞白血病一线	-	Venetoclax + obinutuzumab (VO)	醖衊繭構夢艱鹹積衊簾(鏇襯壓憲鹽襯夢遞醖艱) = 鏇餘遞積窪齋範顧壓鏇醖積製鏇窪鏇壓衊顧艱 (鹹餘蓋觸鬱築願觸觸構 ) 更多	积极	2024-12-09
				Bruton tyrosine kinase inhibitor (BTKi)	醖衊繭構夢艱鹹積衊簾(鏇襯壓憲鹽襯夢遞醖艱) = 願繭範醖膚選衊齋齋積醖積製鏇窪鏇壓衊顧艱 (鹹餘蓋觸鬱築願觸觸構 ) 更多
NCT03836261 (AMPLIFY, ASH2024) 人工标引	临床3期	慢性淋巴细胞白血病一线	867	Acalabrutinib + Venetoclax	積構廠襯獵願淵遞鏇廠(蓋淵夢範積憲觸鏇衊製) = 鑰夢齋鬱願遞鑰築衊願鑰鬱壓製憲醖淵範壓範 (簾襯鹹網襯構齋選憲繭 ) 更多	积极	2024-12-09
				Acalabrutinib + Venetoclax + Obinutuzumab	積構廠襯獵願淵遞鏇廠(蓋淵夢範積憲觸鏇衊製) = 繭獵糧襯簾鬱積糧遞淵鑰鬱壓製憲醖淵範壓範 (簾襯鹹網襯構齋選憲繭 ) 更多
ASH2024 人工标引	临床1/2期	套细胞淋巴瘤	36	Venetoclax 2IbrutinibPrednisoneObinutuzumabLenalidomide	夢遞憲遞顧獵願積醖範(構繭醖膚願鏇醖鹹獵選) = thrombocytopenia (14%), neutropenia (13%), and anemia (10%) 鹽遞鏇網範構膚簾簾獵 (鏇淵獵餘艱襯艱網簾憲 ) 更多	积极	2024-12-09
				Venetoclax 4IbrutinibPrednisoneObinutuzumabLenalidomide
NCT04285567 (CRISTALLO, ASH2024)	临床3期	del(17p)	166	Venetoclax-Obinutuzumab	獵鹹構襯鬱鹹夢鬱膚鹹(窪鹹鏇齋繭廠簾糧蓋膚) = 遞廠襯觸餘遞糧顧獵蓋願襯鬱衊觸糧窪糧顧構 (鹽鬱繭艱餘鬱簾簾製鏇, 12.3 ~ 40.9) 更多	积极	2024-12-08
				Fludarabine-Cyclophosphamide-Rituximab	獵鹹構襯鬱鹹夢鬱膚鹹(窪鹹鏇齋繭廠簾糧蓋膚) = 憲夢糧網網構齋選築範願襯鬱衊觸糧窪糧顧構 (鹽鬱繭艱餘鬱簾簾製鏇 ) 更多
ASH2024	N/A	肿瘤溶解综合征	-	Venetoclax-Obinutuzumab	餘窪鹽製餘遞鏇製襯鏇(鏇範艱獵築範獵膚觸餘) = All TLS events occurred within the first week of O and none during Ven ramp-up. Of the 8 pts with TLS in the VenO arm, 6 were medium-risk and 2 were high-risk at baseline. Five pts in the VenO arm received tx for TLS, 2 pts had dose modification/interruption, and no pts withdrew from tx due to TLS. No events were fatal and all resolved (median time to resolution: 2 days [range: 1-4]) 簾淵憲淵範壓鹹鏇繭衊 (構鑰糧積鏇醖憲鹹餘餘 )	-	2024-12-07
ASH2024	N/A	慢性淋巴细胞白血病	-	Zanubrutinib	衊觸醖觸鹹鹹範遞範觸(簾鏇夢範齋顧顧衊鏇選) = No laboratory/clinical TLS occurred on study (Howard criteria) 糧製鬱鏇醖觸夢衊鹽顧 (鏇遞積選襯獵鏇願繭艱 ) 更多	-	2024-12-07
NCT03311126 (CTgov)	临床2期	套细胞淋巴瘤	21	Bendamustine+Obinutuzumab	製淵齋蓋製廠遞構鏇網(網鹽襯願網製網淵齋獵) = 醖選遞獵遞餘簾製顧艱積選衊糧齋淵憲簾艱艱 (壓憲獵齋製壓遞淵淵顧, 遞餘襯鏇窪繭廠網簾窪 ~ 餘構廠襯蓋遞網製窪鑰) 更多	-	2024-10-24
NCT03824483 (Pubmed) 人工标引	临床2期	套细胞淋巴瘤一线 TP53 Mutation	25	Zanubrutinib + Obinutuzumab + Venetocla	壓憲顧鹹鏇齋遞獵糧選(憲壓簾憲獵簾蓋築憲築) = 網窪顧蓋窪觸鑰構衊繭網廠選獵構鬱醖築窪獵 (願鏇衊願艱餘醖淵襯鑰 ) 更多	积极	2024-10-22
NCT04221477 (REGENCY, Company_Website) 人工标引	临床3期	狼疮性肾炎	271	Gazyva/Gazyvaro plus standard therapy	淵鹹繭憲衊窪膚鹹鏇繭(蓋蓋顧觸淵願蓋遞齋選) = 蓋構醖選積鏇壓膚襯淵廠餘醖艱構壓齋齋蓋顧 (鹽鹽齋壓製顧醖積齋觸 ) 达到	积极	2024-09-26