达雷妥尤单抗(Daratumumab) - 药物靶点：CD38_在研适应症：阴燃多发性骨髓瘤，免疫球蛋白轻链淀粉样变性，多发性骨髓瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Daratumumab (Genetical Recombination)、达雷木单抗、JNJ-54767414

+ [6]

靶点

CD38

作用方式

抑制剂

作用机制

CD38抑制剂(淋巴细胞分化抗原CD38抑制剂)、ADCC(抗体依赖的细胞毒作用)、抗体依赖的细胞吞噬作用

治疗领域

肿瘤免疫系统疾病内分泌与代谢疾病+ [7]

在研适应症

阴燃多发性骨髓瘤免疫球蛋白轻链淀粉样变性多发性骨髓瘤+ [19]

非在研适应症

淋巴母细胞淋巴瘤难治性B细胞淋巴瘤结外NK-T细胞淋巴瘤+ [12]

原研机构

Janssen Global Services LLC

在研机构

Janssen Research & Development LLC

Genentech, Inc.

西安杨森制药有限公司

+ [17]

非在研机构-

权益机构

Genmab A/S

Janssen Biotech, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2015-11-16),

多发性骨髓瘤

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、孤儿药 (韩国)、孤儿药 (英国)、优先审评 (日本)、附条件批准 (中国)、孤儿药 (日本)

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结构/序列

Sequence Code 9075449L

来源: *****

Sequence Code 9946743H

来源: *****

关联

353

项与达雷妥尤单抗相关的临床试验

NCT07072585

/ Not yet recruiting临床2/3期IIT

A Phase 2/3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)

This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.

开始日期2026-03-30

申办/合作机构

The Children's Oncology Group Foundation, Inc.

NCT07082270

/ Not yet recruiting临床1期IIT

Phase I Trial of GB1211 (Selvigaltin), an Oral Galectin-3 (Gal-3) Inhibitor, Combined With Standard of Care Treatment in Relapsed/Refractory Multiple Myeloma (RRMM)

This phase I trial studies the side effects and best dose of selvigaltin when given together with standard of care treatment (daratumumab-hyaluronidase, carfilzomib, dexamethasone) in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Selvigaltin works by blocking the activity of a protein called galectin-3. Galectin-3 is involved in various cellular processes, including inflammation and tissue scarring, which is associated with worse outcomes in several forms of cancer. By blocking the activity of galectin-3, selvigaltin may help reduce inflammation and tissue scarring. Daratumumab-hyaluronidase is a drug composed of daratumumab and hyaluronidase. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Hyaluronidase helps deliver the daratumumab to CD38-expressing cancer cells. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving selvigaltin with standard of care treatment may be safe, tolerable, and/or effective in treating patients with relapsed or refractory multiple myeloma.

开始日期2026-02-01

申办/合作机构

Roswell Park Comprehensive Cancer Center

NCT07191379

/ Not yet recruiting临床4期IIT

Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma. An Open Label, Phase Four, Prospective, Non-randomized, Sponsor-initiated Multicenter Feasibility Study

The main goal in this open label, phase four, prospective, non-randomized, sponsor-initiated multicenter feasibility study is to evaluate the feasibility and safety of self-administration of subcutaneously (SC) daratumumab in the patients with multiple myeloma in their own home. The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. To reduce potential bias, patients will function as their own controls by receiving alternating treatments at home and in the outpatient clinic. To participate, patients must be scheduled for SC daratumumab alone or in combination with other drugs not necessitating outpatient visits on days of planned SC daratumumab self-administration. Patients can be included and trained during cycle 1 and 2, but only treatments administered in cycle 3-6 are considered protocol treatments. Here, patients will receive SC daratumumab once every second week with treatments at day 1 administered in the outpatient clinic and treatments at day 15 administered at home. From cycle 7 onwards, patients continues SC daratumumab outside protocol according to local standards.
At inclusion, baseline demographic and clinical data should be registered for included patients. For each SC daratumumab administration in the protocol, planned treatment location (home/hospital) should be registered together with information on whether the dose was administered as planned. For each protocol treatment, regardless of treatment location, patients, caregivers, and healthcare professionals should register their time spent. In addition, patients should complete the Health Literacy Questionnaire (HLQ) and caregivers are to complete the Caregiver Roles and Responsibilities Scale (CRRS). Throughout the study, patient will also register all unplanned contacts to the healthcare system. Patient will also be asked to complete an evaluation form. Lastly, qualitative evaluations of the experience of self-administration will be conducted through semi-structured interviews with patients and caregivers, as well as focus group interviews with involved healthcare professionals.

开始日期2026-01-01

申办/合作机构

Odense University Hospital

100 项与达雷妥尤单抗相关的临床结果

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100 项与达雷妥尤单抗相关的转化医学

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100 项与达雷妥尤单抗相关的专利（医药）

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2,148

项与达雷妥尤单抗相关的文献（医药）

2026-01-01·BIOMATERIALS

CD38-targeted antibody-polymer drug conjugates for enhanced treatment of multiple myeloma

Article

作者: Li, Shannuo ; Al Faruque, Hasan ; Yang, Jiyuan ; Li, Jiahui ; Kopeček, Jindřich ; Sborov, Douglas W

Multiple myeloma (MM) remains a formidable disease, especially in relapsed or refractory cases when there are limited treatment options. In this study, we introduce two polymer-antibody drug conjugates (pADCs), ISA-P-EPI (U6244-021) and DARA-P-EPI (U6244-031), which contain semitelechelic N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer-epirubicin (EPI) conjugate attached to CD38-targeting antibodies Isatuximab (ISA) and Daratumumab (DARA). These pADCs enhance therapeutic efficacy by combining the specificity of ISA and DARA with the cytotoxic potency of EPI while preserving antibody function. The EPI is linked to the HPMA polymer backbone via a tetrapeptide spacer cleavable by lysosomal enzymes, enabling drug release upon endocytosis within tumor cells. This design achieves a higher drug-to-antibody ratio than conventional ADCs for safer delivery of drug payload. In vitro studies demonstrate efficient binding, internalization, and cytotoxic efficacy of these pADCs in MM cell lines. Mechanistic investigations revealed significant therapeutic effects, including cell cycle arrest, immunogenic cell death, and preserved antibody-dependent cellular cytotoxicity (ADCC). In addition, pADCs were effective in 5 out of 8 primary samples, with their efficacy closely correlating with CD38 surface expression levels. To enhance therapeutic outcomes, we employed panobinostat to upregulate CD38 expression, which further improved pADC efficacy. In a preclinical NRG mouse model inoculated with MM.1S-luc cells, pADC treatment significantly delayed tumor progression and prolonged survival, with all treated mice remaining alive at the 100-day endpoint. These findings underscore the potential of CD38-targeted pADCs as a novel approach to combining chemotherapy with immunotherapy for MM treatment, warranting further investigation into their optimization and clinical application.

2025-12-31·ANNALS OF MEDICINE

Serum free light chain level-based and non-fixed cycle daratumumab treatment strategy for patients with light chain amyloidosis

Article

作者: Huang, Xianghua ; Guo, Jinzhou ; Chen, Wencui ; Li, Zhen ; Zhao, Liang ; Ren, Guisheng

BACKGROUND:

In recent years, daratumumab (DARA) has gained widespread use in the treatment of systemic light chain (AL) amyloidosis. In this study, we assessed the efficacy and safety of a DARA treatment strategy based on serum free light chain (sFLC) levels and non-fixed cycles.

METHODS:

The study included 123 patients with Al amyloidosis who received DARA at our center between July 2020 and September 2023. All patients received the standard DARA treatment (16 mg/kg weekly for four weeks) during the first course. Subsequent treatments were adjusted based on sFLC levels and the physician's judgment.

RESULTS:

The results demonstrated an impressive overall hematologic response rate (ORR) of 94.3%, with a hematologic very good partial response (VGPR) and complete response (CR) rate of 84.5%. Median time to best hematologic response was 1 months. Cardiac and renal response rates were 39.3% and 60.3%, respectively. Thirty patients experienced grade 1/2 infusion-related reactions after the first infusion. The rate of grade 3/4 adverse events was 21%. The most common adverse events of grade 3 or 4 were pulmonary infection (6.5%), neutropenia and lymphocytopenia (5.7%), elevated transaminases (1.6%), acute kidney injury (1.6%). After a median follow-up of 13 months (range 1-38), The 1-year OS and PFS estimates were 96.5% and 84.4%, respectively.

CONCLUSION:

These findings indicate that the sFLC levels based and non-fixed cycle DARA strategy is an efficacious and safe treatment strategy in both newly diagnosed and relapsed/refractory AL amyloidosis.

2025-12-31·ANNALS OF MEDICINE

Clinical outcome of ≥2% circulating tumor cells in newly diagnosed multiple myeloma: insights from a multicenter study

Article

作者: Liang, Dong ; Wang, Hua ; Xia, Zhongjun ; Feng, Yuan ; Yan, Yurong ; Jin, Fengyan ; Chen, Xiaoqin ; Zeng, Min ; Nie, Xiaomiao ; Bu, Yuying ; Bai, Shenrui ; Liang, Yang ; Wang, Qiaoli ; Xu, Weiling ; Feng, Demei

PURPOSE:

Previous studies have shown that ≥2% circulating tumor cells (CTCs) in multiple myeloma are associated with a prognosis similar to primary plasma cell leukemia. This study aims to examine this ultra-high-risk patient subset and evaluate their clinical outcomes in a real-world clinical setting.

METHODS:

We included 1,056 newly diagnosed multiple myeloma patients treated with novel agents. CTCs levels were determined via morphological assessment on peripheral blood smears, using a 2% cutoff to stratify patients into <2% and ≥2% CTCs groups. We then evaluated clinical outcomes across these groups.

RESULTS:

Patients with ≥2% CTCs constitute an ultra-high-risk subgroup, with outcomes resembling those of primary plasma cell leukemia. Survival outcomes improved for patients receiving daratumumab-based quadruplet therapy. Single autologous stem cell transplantation (ASCT) partially improved outcomes for patients with ≥2% CTCs. Achieving complete remission (CR) after induction treatment did not confer a better prognosis for this population. Furthermore, one high-risk cytogenetic abnormality (HRA) worsened outcomes in the <2% CTC group, while ≥2 HRA were associated with poorer outcomes in the ≥2% CTC group. Concurrent 1q21+ and other HRA further conferred a worse prognosis. In de novo extramedullary extraosseous (EME) multiple myeloma, defined as patients presenting with soft tissue or visceral plasmacytomas not connected to bone at initial diagnosis, ≥2% CTCs remained a strong predictor of poor prognosis.

CONCLUSION:

Our study suggests that patients with ≥2% CTCs represent a distinct ultra-high-risk subgroup in multiple myeloma and warrant separate consideration. VRD, IRD, DVRD, and DRD were reliable choices as frontline therapies for patients with <2% CTCs. Daratumumab-based quadruplet therapy may be a promising option for patients with ≥2% CTCs. Further research should continue to explore this specific aspect in greater depth.

1,121

项与达雷妥尤单抗相关的新闻（医药）

2025-10-21

·抗体密码

三期成功，强生有望重塑多发性骨髓瘤治疗格局

强生公司近日宣布，其Tecvayli（teclistamab）与Darzalex Faspro（达雷妥尤单抗）联合治疗方案的III期Majestec-3研究达到双重终点：在既往接受过1-3线治疗的多发性骨髓瘤患者中，该组合疗法既显著改善了无进展生存期（PFS），也在关键次要终点总生存期（OS）上表现出获益优势。这是继上月Tecvayli与Darzalex Faspro在新诊断多发性骨髓瘤患者中取得积极早期数据后，强生推动该肿瘤联合疗法向二线治疗领域迈进获得的又一成果。 MajesTEC-3（MMY3001）是一项3期、随机、开放标签研究，旨在评估TECVAYLI联合DARZALEX FASPRO®（达雷妥尤单抗与透明质酸酶）对比研究者选择的两种方案——DARZALEX FASPRO+泊马度胺+地塞米松（DPd）或DARZALEX FASPRO+硼替佐米+地塞米松（DVd）——在既往接受过1-3线治疗的复发/难治性多发性骨髓瘤患者中的疗效与安全性。若最终获批二线治疗，将显著提升Tecvayli在多发性骨髓瘤治疗序列中的地位。目前这款BCMA靶向双特异性T细胞衔接剂仅获FDA批准用于既往接受过至少四线治疗的复发/难治性患者。值得注意的是，该药在欧盟的适用范围更为宽松，早在2022年8月就获批用于既往三线治疗后的骨髓瘤患者。强生未披露具体数据，但指出独立数据监察委员会基于显著统计学意义建议揭盲。公司计划向监管机构提交结果，并在未来医学会议上公布详细数据。这项III期研究对照组为Darzalex Faspro联合免疫调节剂泊马度胺/地塞米松，或蛋白酶体抑制剂硼替佐米/地塞米松。经过近三年随访，Tecvayli方案在双重终点均显示统计学显著优势，安全性特征与单药治疗一致。此前九月公布的II期MajesTEC-5研究显示，该联合疗法在新诊断移植适宜患者中取得100%总缓解率，所有可评估患者诱导治疗结束后均达到微小残留病变阴性。另外，针对不适合干细胞移植患者的一线治疗研究Majestec-7正在评估Tecvayli+达雷妥尤单抗方案，以及达雷妥尤单抗联合GPRC5D靶向T细胞衔接器Talvey的方案，2024年ASCO年会公布的安全性导入期数据显示，Tecvayli+达雷妥尤单抗+来那度胺三联方案客观缓解率（ORR）达92%。除了目前的疗法，强生也在积极布局下一代疗法，正在进行的Monumental-6研究评估Tecvayli与Talvey联合治疗复发骨髓瘤，预计明年完成开发同时靶向BCMA与GPRC5D的双特异性T细胞衔接器JNJ-79635322，早期数据在ASCO展示时引发"媲美CAR-T疗法"的评价有分析师曾预测Tecvayli销售峰值有望突破20亿美元。2024年该药实现5.49亿美元销售额，同比增长39%；2025年第三季度销售额达1.77亿美元，同比激增约60%，呈现强劲增长态势。我们已经建立抗体密码读者交流群，有兴趣的可以扫描下方二维码添加微信进群，请主动备注姓名-公司-职位（高校-专业），非诚勿扰！往期精彩回顾抗体密码文章合集双特异抗体平台靶点相关双特异抗体作用机制综述，行业概览抗体筛选技术相关公司技术汇总医药资讯因为你的分享、点赞、在看我足足的精气神儿！声明本公众号所发表文章以宣传知识为目的，因此不构成投资，病人用药等建议。如果文章侵您的权益及时联系小编进行删除！欢迎扫码交流/咨询/合作=

ASCO会议免疫疗法临床结果细胞疗法临床3期

2025-10-19

·百度百家

全球10大制药巨头

全球制药界这潭水，最近可是搅动得厉害！你说这些个医药巨头，哪个不是富得流油？但你知道吗？他们赚钱的背后，藏着多少不为人知的故事？这不，最新出炉的2024-2025年全球制药企业排名，又一次把这些大佬们拉出来溜了一圈。先说说这排名前十的，那可真是个个身怀绝技。强生、艾伯维、默沙东，这三家美国公司简直就是制药界的“三巨头”，牢牢占据着前三的位置。强生靠着肿瘤药Darzalex和免疫药物Stelara，一年就能卖出几百亿美元，这赚钱速度，简直比印钞机还快！艾伯维也不甘示弱，免疫疾病药物Skyrizi同样是吸金利器。而默沙东更狠，直接靠着抗癌神药Keytruda（K药），一年狂揽近300亿美元！这K药，简直就是默沙东的“摇钱树”，谁能想到，一颗药就能撑起一家公司呢？瑞士的罗氏也不简单，制药业务收入高达524.6亿美元，肿瘤药和诊断技术双管齐下，特别是法瑞西单抗（Vabysmo），一年增长68%，这速度，简直像坐了火箭！辉瑞虽然排在第五，但人家也不傻，赶紧通过收购Seagen布局ADC抗癌药物，肿瘤业务收入也超过了150亿美元。这辉瑞，看来是铁了心要在抗癌领域大干一场了。英国的阿斯利康在新兴市场表现那是相当抢眼，肿瘤药收入占比高达41%。瑞士的诺华则专注于心血管、眼科和肿瘤领域，CAR-T疗法更是领先全球。美国的百时美施贵宝，抗凝药Eliquis和抗癌药是两大支柱。法国的赛诺菲，自免药物Dupixent年销136亿美元，还布局罕见病基因疗法，这眼光，那是相当长远。最后说说丹麦的诺和诺德，这家公司可真是靠“减肥药”火了一把！司美格鲁肽（减肥/降糖药）年销292亿美元，这减肥药市场，简直就是一座金矿啊！难怪现在大家都说，减肥才是第一生产力！看到这里，你是不是觉得这些制药巨头赚钱太容易了？但你知道吗？他们背后的研发投入也是巨大的！头部企业研发投入均超80亿美元，默沙东更是以178.6亿美元居首。这研发投入，可不是闹着玩的，没有真金白银的投入，哪来新药的问世？而且，你有没有发现，肿瘤和代谢疾病（如减肥药）成了创新焦点。这也不难理解，毕竟现在生活压力大，得肿瘤的人越来越多，想减肥的人也越来越多，这些都是巨大的市场需求啊！值得一提的是，中国的药企百济神州首次进入全球50强，虽然没能跻身前十，但也算是一个不小的突破。这说明中国的医药行业正在崛起，未来可期啊！当然，这仅仅是冰山一角。医药行业的水深着呢，里面的门道多着呢。这些制药巨头之间的竞争，新药研发的背后故事，以及未来医药行业的发展趋势，都值得我们好好关注。毕竟，这关系到我们每个人的健康，不是吗？那么，问题来了，这些制药巨头为什么这么热衷于研发新药？仅仅是为了赚钱吗？还是有其他的考量？未来的医药行业又将走向何方？中国的医药企业又该如何抓住机遇，迎头赶上？这些问题，值得我们深入思考。再说了，这些药企的研发费用都花在哪了？是真金白银地投入了研发，还是打了水漂？这恐怕只有他们自己心里清楚了。而且，这些新药的价格，动辄成千上万，普通老百姓又能负担得起吗？这又是一个值得深思的问题。还有，这些制药巨头之间的“宫斗戏”，也是精彩纷呈。为了争夺市场份额，他们可是使出了浑身解数。明争暗斗，尔虞我诈，简直比电视剧还好看。总而言之，全球制药巨头的故事，远比我们看到的要复杂得多。这不仅仅是关于金钱和利益，更是关于健康和生命。我们作为普通人，可能无法左右这些巨头的决策，但我们可以保持关注，理性思考，为自己和家人的健康保驾护航。

抗体药物偶联物并购基因疗法免疫疗法

2025-10-16

·药明康德

95%脱发患者发量改善！小分子获1.5亿美元助力推进上市；首个！显著延长癌症患者生命，Keytruda联合疗法3期结果公布……

95%脱发患者发量改善！小分子获1.5亿美元助力推进上市 Veradermics今日宣布完成超额认购的1.5亿美元C轮融资。此次融资将用于推进其核心在研产品VDPHL01的注册性试验及预定的新药申请（NDA）提交。VDPHL01是一款专为男女脱发患者设计、潜在首款缓释口服minoxidil候选药物，目前正在进行3期试验。本轮融资由SR One领投，新加入投资方包括Viking Global Investors、Marshall Wace、Invus、abrdn管理的基金、Columbia Threadneedle Investments、Infinitium与LifeSci Venture Partners，现有投资方Longitude Capital、Suvretta Capital Management、Surveyor Capital等继续加持，另有未披露投资者参与。公司同时公布了进行中2期临床研究的初步结果，该研究评估VDPHL01用于治疗男女模式性脱发（pattern hair loss）的疗效与安全性。在2期研究的男性队列中，21名受试者接受每日两次（BID）8.5 mg VDPHL01达两个月后，主要终点非毳毛靶区毛发计数较基线平均增加37.5根/平方厘米；至第4个月，同一批受试者的该指标平均增至较基线增加47.3根/平方厘米。主观评价方面，两个月时55%的受试者报告头发覆盖度“改善”或“显著改善”，至第4个月这一比例升至90.5%；在4个月结束时，95%的受试者表示对头发覆盖度的满意度提高。安全性上，VDPHL01迄今总体耐受性良好，未观察到任何严重不良事件，包括心血管相关不良事件。首个！显著延长癌症患者总生存期，Keytruda联合疗法3期结果公布默沙东（MSD）今日公布3期KEYNOTE-B96研究的积极结果。该研究评估其PD-1抑制剂Keytruda（pembrolizumab）联合化疗（紫杉醇），可合并或不合并贝伐珠单抗，用于治疗铂耐药复发性卵巢癌的疗效与安全性。此前的期中分析已显示，KEYNOTE-B96在PD-L1阳性人群及全体入组人群中均达到主要终点无进展生存期（PFS），并在PD-L1阳性人群中达到总生存期（OS）这一关键次要终点。在最终分析中，与安慰剂联合化疗（可合并或不合并贝伐珠单抗）相比，基于Keytruda的治疗方案在所有入组患者中带来具有统计学和临床意义的OS改善。该研究中Keytruda的安全性与既往研究一致，未发现新的安全性信号。根据新闻稿，KEYNOTE-B96是首个在铂耐药复发性卵巢癌中，基于免疫检查点抑制剂的治疗方案相较安慰剂联合化疗（可合并或不合并贝伐珠单抗）在PD-L1阳性人群及全体入组人群均显示出OS显著获益的研究。显著延长癌症患者总生存期！强生双抗组合3期结果公布强生（Johnson & Johnson）今日宣布，其3期MajesTEC-3研究取得期中结果。该研究评估Tecvayli（teclistamab）联合Darzalex Faspro（daratumumab & hyaluronidase）用于既往接受过1–3线治疗的复发/难治性多发性骨髓瘤（RRMM）患者，与研究者选择的两种标准治疗方案相比的疗效与安全性。经过近三年的随访，Tecvayli联合Darzalex Faspro达到了主要终点，其PFS显著优于标准治疗，且差异具有统计学意义；同时，在首次期中分析中，OS这一关键次要终点也达到了统计学显著性。根据新闻稿，MajesTEC-3是首个在二线治疗阶段即显示PFS与OS获益的在研联合方案3期研究。基于上述具有统计学显著性的结果，独立数据监查委员会（IDMC）已建议对研究进行揭盲。 Tecvayli是一款完全人源化、同时靶向BCMA与T细胞表面CD3受体的双特异性抗体；它既是首款获批用于治疗多发性骨髓瘤的双特异性疗法，也是首款获批靶向BCMA的双特异性抗体。Darzalex Faspro则为皮下注射的CD38靶向单克隆抗体。参考资料： [1] Veradermics Announces Oversubscribed $150 Million Series C Financing to Advance VDPHL01 Through Multiple Phase 3 Trials as Potentially the First Non-Hormonal Oral Therapeutic for Hair Regrowth in Women and Men. Retrieved October 16, 2025 from https://www.veradermics.com/veradermics-announces-150million-seriesc-financing [2] TECVAYLI® plus DARZALEX FASPRO® combination regimen significantly improves progression-free survival and overall survival versus standard of care. Retrieved October 16, 2025 from https://www.jnj.com/media-center/press-releases/tecvayli-plus-darzalex-faspro-combination-regimen-significantly-improves-progression-free-survival-and-overall-survival-versus-standard-of-care [3] Merck Announces Phase 3 KEYNOTE-B96 Trial Met Secondary Endpoint of Overall Survival (OS) in All Comers Population of Patients With Platinum-Resistant Recurrent Ovarian Cancer. Retrieved October 16, 2025 from https://www.merck.com/news/merck-announces-phase-3-keynote-b96-trial-met-secondary-endpoint-of-overall-survival-os-in-all-comers-population-of-patients-with-platinum-resistant-recurrent-ovarian-cancer/ 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期临床成功临床2期临床结果

100 项与达雷妥尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10777	达雷妥尤单抗	L01XC24	DB09331

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
阴燃多发性骨髓瘤	欧盟	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	冰岛	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	列支敦士登	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	挪威	Janssen-Cilag International NV	2025-07-24
免疫球蛋白轻链淀粉样变性	欧盟	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	冰岛	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	列支敦士登	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	挪威	Janssen-Cilag International NV	2016-05-20
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2015-11-16

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
复发性多发性骨髓瘤	临床3期	美国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	日本	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	澳大利亚	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	比利时	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	丹麦	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	法国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	德国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	希腊	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	以色列	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	意大利	Janssen Research & Development LLC	2020-06-12

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临床结果

适应症

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


NCT03792620 (Pubmed)	临床2期	多发性骨髓瘤 CD38	24	Daratumumab, Cyclophosphamide, Thalidomide, Dexamethasone	醖顧淵鑰壓齋齋鑰糧蓋(窪鏇築襯廠壓簾觸積網) = 蓋選製廠繭鏇餘觸餘願淵遞積夢鑰蓋衊積鏇積 (範壓遞製餘獵廠鏇願衊, 68.3 ~ 98.7)	积极	2025-08-01
NCT04230304 (CTgov)	临床2期	复发性慢性淋巴细胞白血病 \| 难治性慢性淋巴细胞白血病 \| 难治性小淋巴细胞淋巴瘤	8	Ibrutinib+Daratumumab	蓋鑰膚艱鏇淵築衊鏇願 = 積壓願遞鹽鬱衊艱觸蓋鏇憲鬱鏇糧積製餘蓋製 (餘蓋簾構襯糧觸網窪醖, 餘艱艱選鹹艱鬱觸齋觸 ~ 艱鑰選繭窪選鏇遞繭願) 更多	-	2025-07-01
NCT03012880 (CTgov)	临床2期	多发性骨髓瘤	80	lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort A)	鬱願醖膚廠鹽衊窪網獵 = 壓襯鑰廠淵顧壓鹹鬱顧積構觸襯艱顧選網鹹積 (淵衊糧餘選鏇遞積觸淵, 鹹壓壓簾廠憲鹽鹹網餘 ~ 鏇憲鏇網鹹遞積網鏇鹽) 更多	-	2025-06-04
				lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort B)	鬱願醖膚廠鹽衊窪網獵 = 鏇糧顧繭鬱蓋襯遞淵窪積構觸襯艱顧選網鹹積 (淵衊糧餘選鏇遞積觸淵, 鏇願遞艱鑰積顧壓網衊 ~ 壓衊廠艱鬱鏇廠選鏇獵) 更多
ASCO2025	N/A	多发性骨髓瘤	804	Daratumumab	鹹艱積鑰憲顧觸艱廠積(壓網鏇範選鬱憲觸鏇醖) = 遞膚獵夢鬱範選夢艱餘願鹹蓋鑰艱蓋鹹壓觸廠 (顧鹽製構窪製遞鏇鏇壓 ) 更多	积极	2025-05-30
				Lenalidomide	鹹艱積鑰憲顧觸艱廠積(壓網鏇範選鬱憲觸鏇醖) = 鹹糧夢獵襯鏇廠醖鏇鏇願鹹蓋鑰艱蓋鹹壓觸廠 (顧鹽製構窪製遞鏇鏇壓 ) 更多
NCT04268498 (ADVANCE, ASCO2025)	临床2期	多发性骨髓瘤 minimal residual disease (MRD) positive	306	DKRd (Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone)	窪願鑰膚繭構觸鏇壓襯(夢範築壓壓遞鏇獵獵願): adjusted OR = 2.5 (95% CI, 1.5 ~ 4.2) 更多	积极	2025-05-30
				KRd (Carfilzomib, Lenalidomide, Dexamethasone)
NCT04661137 (phase 2b study of selinexor, ASCO2025)	临床2期	多发性骨髓瘤	28	Selinexor 80 mg + Carfilzomib 20 mg/m2 + Dexamethasone	壓構積範膚膚襯觸製選(窪獵鏇窪壓鏇鹹築艱鬱) = 簾夢網築窪糧齋淵繭願積憲餘觸遞壓築夢糧顧 (膚鹹願膚窪餘艱鏇蓋夢 ) 更多	积极	2025-05-30
				Selinexor 60 mg + Pomalidomide 4 mg + Dexamethasone	壓構積範膚膚襯觸製選(窪獵鏇窪壓鏇鹹築艱鬱) = 鑰艱網壓遞獵襯廠膚衊積憲餘觸遞壓築夢糧顧 (膚鹹願膚窪餘艱鏇蓋夢 )
CEPHEUS (EHA2025)	临床3期	多发性骨髓瘤 del(17p) \| t(4;14) \| t(14;16) ... 更多	395	DARATUMUMAB, BORTEZOMIB, LENALIDOMIDE AND DEXAMETHASONE (DVRd)	網觸衊鏇範顧網築選鹹(積餘鹽餘壓鏇憲淵壓鏇) = 壓窪膚網觸鬱繭齋構鏇淵膚襯壓鹹積積鏇繭鹽 (蓋鏇繭餘觸範構遞鏇願 ) 更多	积极	2025-05-22
NCT04181827 (CARTITUDE-4, CTgov)	临床3期	复发性多发性骨髓瘤 \| 多发性骨髓瘤	419	daratumumab+pomalidomide+bortezomib+dexamethasone (DPd) (Arm A: Standard Therapy: PVd or DPd)	鹹網憲築鬱顧鹽鏇遞鹹(襯齋廠觸構範艱願願鏇) = 範構積糧膚顧糧鏇窪廠衊鏇網膚願餘遞繭衊願 (壓築醖壓鏇選獵齋構製, 齋壓襯醖膚壓膚築膚淵 ~ 獵鹽齋選醖鏇積壓膚簾) 更多	-	2025-05-20
				Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))	鹹網憲築鬱顧鹽鏇遞鹹(襯齋廠觸構範艱願願鏇) = 蓋艱遞遞窪窪觸齋淵獵衊鏇網膚願餘遞繭衊願 (壓築醖壓鏇選獵齋構製, 製遞繭醖膚構繭觸網獵 ~ 顧繭鏇網選鬱糧壓選顧) 更多
PF767 (EHA2025)	N/A	多发性骨髓瘤	99	Daratamumab+Bortezomib+Lenalidomide+Dexamethasone (DVRd)	網繭簾廠艱膚醖艱夢淵(壓襯糧齋糧鹹鹽製醖製) = 遞遞獵膚選淵觸積構醖顧淵獵艱餘獵蓋鏇窪衊 (顧夢網糧鹽襯簾鏇願淵 ) 更多	积极	2025-05-14
				Bortezomib+Lenalidomide+Dexamethasone (VRd)	網繭簾廠艱膚醖艱夢淵(壓襯糧齋糧鹹鹽製醖製) = 憲壓網蓋觸願製簾觸糧顧淵獵艱餘獵蓋鏇窪衊 (顧夢網糧鹽襯簾鏇願淵 ) 更多
NCT04703621 (THE DART STUDY, EHA2025)	临床2期	免疫性血小板减少症二线	21	Daratumumab	廠糧顧構繭廠鏇築構鬱(選繭範襯鑰醖製壓製繭) = Infections were the most common treatment-emergent adverse events (38%) 淵顧糧鏇淵積構鏇壓襯 (廠廠築壓鹽鏇夢膚遞觸 ) 更多	积极	2025-05-14