达雷妥尤单抗(Daratumumab) - 药物靶点：CD38_在研适应症：免疫球蛋白轻链淀粉样变性，多发性骨髓瘤，阴燃多发性骨髓瘤_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+ [5]

在研适应症

免疫球蛋白轻链淀粉样变性多发性骨髓瘤阴燃多发性骨髓瘤+ [19]

非在研适应症

淋巴母细胞淋巴瘤结外NK-T细胞淋巴瘤滤泡性淋巴瘤+ [10]

原研机构

Janssen Global Services LLC

在研机构

西安杨森制药有限公司Janssen R&D Ireland Share Participation Scheme

Janssen Biotech, Inc.

+ [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

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

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结构/序列

Sequence Code 9075449L

来源: *****

Sequence Code 9946743H

来源: *****

关联

324

项与达雷妥尤单抗相关的临床试验

NCT06570915

/ Not yet recruiting临床2期IIT

A Prospective, Single-arm, Multicenter, Open-label , Phase 2 Study to Evaluate Efficacy and Safety of the Daratumumab in T Cell Acute Lymphoblastic Leukemia With Minimal Residual-Positive After Standard Chemotherapy

T-ALL accounts for about 15%-25% of Ph-negative ALL, and its clinical prognosis is worse than B-ALL. The successful application of immunotherapy has brought revolutionary progress to the treatment of ALL. But progress in the treatment of T-ALL has been relatively slow. Minimal residual disease (MRD) is a strong prognostic indicator for ALL patients. MRD-positive after induction therapy predicts a high risk of relapse. The National Comprehensive Cancer Network (NCCN) considers MRD-positive ALL patients to be at high risk. Research in the B-ALL field has demonstrated that immunotherapy has the potential to further clear MRD, which in turn translates into survival benefits. Daratumumab is a humanized, anti-CD38 IgG1 monoclonal antibody that binds to CD38 expressed by tumor cells. Apoptosis of tumor cells is induced through a variety of immune-related mechanisms such as complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cytophagocytosis (ADCP), and FCγ receptors, which are currently mainly used in the treatment of multiple myeloma. CD38 is highly and stably expressed on the surface of T-ALL cells, and its expression was less influenced by the previous treatment. Preliminary data from the clinical study of daratumumab combined with BFM bone frame prescription for the treatment of recurrent refractory T ALL(NCT03384654) showed that the effectiveness rate (ORR) was 83.3% in children and 60% in young adults. Compared with the previous historical data, the safety and tolerability were significantly improved. For T-ALL patients who relapse after allogeneic transplantation and achieve CR with intense chemotherapy but continue to have MRD-positive flow rate, daratumumab monotherapy can further clear MRD and achieve the purpose of sustaining CR. These studies all demonstrate the potential role of daratumumab in the treatment of T-ALL. Based on the current difficulties in the treatment of T-ALL and existing research data, we plan to conduct a prospective, single-arm, open-label phase II clinical study to explore the efficacy and safety of daratumumab for flow minimal residual disease positive T-ALL after standard chemotherapy.

开始日期2025-12-01

申办/合作机构

中国医学科学院血液病医院

NCT06932562

/ Not yet recruiting临床3期IIT

A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).
The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.

开始日期2025-09-01

申办/合作机构

European Myeloma Network

[+1]

NCT06948084

/ Not yet recruiting临床2期IIT

A Randomized Phase II Trial for High-Risk Multiple Myeloma That is Refractory or in First Relapse With Daratumumab, Teclistamab (DT) Versus Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Carfilzomib, Dexamethasone (DKd)

This phase II trial compares the effect of the combination of daratumumab-hyaluronidase (daratumumab) and teclistamab to the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in treating patients with multiple myeloma that has not responded to previous treatment (refractory) or that has come back after a period of improvement (relapsed). 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. Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen, a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. 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. Carfilzomib, a type of proteasome inhibitor, blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. Giving daratumumab and teclistamab may be more effective than the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in reducing myeloma cells to undetectable levels in patients with relapsed or refractory multiple myeloma.

开始日期2025-07-18

申办/合作机构

National Cancer Institute

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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2,040

项与达雷妥尤单抗相关的文献（医药）

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 ; Nie, Xiaomiao ; Zeng, Min ; 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.

2025-12-31·DRUG DELIVERY

Evaluating nurse preferences for a novel on-body delivery system vs. manual syringes for large-volume subcutaneous drug administration: a survey study

Article

作者: Gorski, Lisa A. ; Curry, Nicole ; Sterlin, Valentina ; Miles, Ashley ; Desai, Mehul ; Faiman, Beth

While nurses report challenges with the manual administration of large-volume subcutaneous drugs, these challenges and potential solutions are not captured in the literature. In this cross-sectional study, 45 nurses with experience administering large-volume subcutaneous biologics completed an 18-item survey about preferences for syringes vs. on-body delivery systems. 100% responded that an on-body delivery system seemed easy to learn and use and preferable to syringes. In a drug delivery scenario including comprehensive administration details and assuming equivalent safety and efficacy, 97.78% preferred the on-body delivery system to a daratumumab/hyaluronidase syringe. In the total sample, this preference was primarily attributed to (1) reduced nurse effort due to hands-free delivery, (2) decreased patient pain due to a thinner needle, (3) elimination of needlestick injuries due to a hidden needle, and (4) increased clinic efficiency due to hands-free delivery. 95.56% felt that the on-body delivery system would improve clinic throughput better than syringes. Nurses reported that an on-body delivery system would be easy to learn and use and would improve clinic efficiency and safety. They underscored the importance of decreasing nurse physical burden, needlestick injuries, and patient needle phobia. Contrary to the assumption that speed is paramount, nurses prioritized reducing effort, enhancing administration safety, and improving patient comfort over injection speed.

986

项与达雷妥尤单抗相关的新闻（医药）

2025-05-29

·PRNewswire

John Theurer Cancer Center Presents Innovative Cancer Research at Major Annual Cancer Meeting, Offering New Hope for Patients

Presentations and publications address novel therapeutics, molecular biology studies, and global trends for blood cancers and solid tumors HACKENSACK, N.J., May 29, 2025 /PRNewswire/ -- Investigators from Hackensack Meridian John Theurer Cancer Center (JTCC)—part of the National Cancer Institute-designated Lombardi Comprehensive Cancer Center at Georgetown University—and Hackensack University Medical Center are reporting research findings from 32 studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting is the premier event for cancer professionals and takes place in Chicago from May 30 to June 3. "The future of cancer treatment begins with the pioneering exploration being carried out today," notes Andre Goy, MD, chair, vice president, physician-in-chief of oncology, at Hackensack Meridian John Theurer Cancer Center. "We are fortunate to be in a time where many cancers will respond to standard treatments. But for those cancers that don't, it's critical that patients have access to a world-class research program that will yield innovative therapies. At John Theurer Cancer Center, our globally recognized investigators continue to drive the latest oncology advances in cellular therapy, immunotherapy and other areas, enabling improved outcomes for patients across the Hackensack Meridian Health network and beyond." Several studies address novel drug combinations for multiple myeloma, as well as racial disparities in treatment outcomes and the expression of key biomarkers. Investigators are also presenting data on emerging immunotherapies for leukemia and lymphoma, molecular markers predicting disease relapse, and innovative treatment regimens such as all-oral therapies for acute myeloid leukemia. Solid tumor studies focus on disparities in gastric cancer, machine learning applications for breast cancer metastasis, and promising antibody-drug conjugates for lung cancer. Investigations related to melanoma and skin cancer examine circulating tumor DNA as a marker for disease progression, comparative survival analyses based on biomarkers, and the identification of targetable mutations across different skin cancer types. These findings underscore the breadth of ongoing efforts at John Theurer Cancer Center—New Jersey's largest cancer center—to refine therapeutic strategies, enhance precision oncology, and improve patient outcomes. Multiple Myeloma Research Carfilzomib, iberdomide, and dexamethasone in patients with transplant-eligible newly diagnosed multiple myeloma: Updated results from phase 1/2 study Updated results from phase 2b study of selinexor in combination with carfilzomib, daratumumab, or pomalidomide in patients with multiple myeloma relapsing on current therapy Real-world outcomes of patients with multiple myeloma treated with T-cell engagers compared to those treated on clinical trials Impact of racial disparities on efficacy and safety outcomes for patients with relapsing/refractory multiple myeloma receiving T-cell engagers Heterogeneity in the expression of GPRC5D between patients with multiple myeloma Evaluation of immune checkpoint inhibitors and concurrent radiation therapy for the treatment of extramedullary multiple myeloma Global burden of multiple myeloma: Analysis from 1980 to 2021 Efficacy and safety of less frequent dosing with elranatamab in patients with relapsed or refractory multiple myeloma: A US subgroup analysis from MagnetisMM-3 Leukemia and Lymphoma Peripheral blood cell-free DNA testing as a predictor for relapse post-allogeneic stem cell transplant for acute myeloid leukemia An all-oral regimen of decitabine-cedazuridine plus venetoclax in patients with newly diagnosed acute myeloid leukemia ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 pts Employing novel pan-cancer targets for immunotherapy in leukemias and solid tumors MRD negativity after end of induction in the phase 3 PhALLCON trial: A post hoc analysis Results from the completed dose-finding part of phase 2 study of the innate cell engager acimtamig (AFM13) in combination with AlloNK (AB-101) in relapsed or refractory classical Hodgkin lymphoma (LuminICE-203) Novel analysis of 3-y results from the pivotal EPCORE NHL-1 study: Outcomes in patients with relapsed/refractory large B-cell lymphoma and complete response at 2 years with epcoritamab monotherapy TITANium: An open-label, global multicenter phase 1/2 study of AZD5492, a first-in-class subcutaneous CD8-guided tri-specific T-cell engager, in patients with relapsed or refractory B-cell malignancies Solid Tumor Research Limited changes in the central nervous system immune microenvironment in patients with breast cancer metastasis and capturing these changes using machine learning Relationship between FOLR1 expression and pan-cancer subgroup of tumors with specific transcriptomic profile Disparities and trends in gastric cancer: Incidence, mortality, and stage-specific trends Prevalence of the HPV, EBV, and TTV viral RNA in the plasma of patients with solid and hematologic neoplasms and the detection of a specific immune signature Global trends in soft tissue and extraosseous sarcomas (1980–2021): Regional and economic disparities ZL-1310, a DLL3 antibody-drug conjugate, in patients with extensive stage small cell lung cancer: Phase 1 trial update Ongoing phase 1/2 trial of the hematopoietic progenitor kinase 1 (HPK1) inhibitor NDI-101150 as monotherapy or in combination with pembrolizumab: Clinical safety and efficacy update in clear cell renal cell carcinoma Ipilimumab and nivolumab in patients with metastatic clear cell renal cell carcinoma treated on the phase 3 PDIGREE (Alliance A031704) trial: Results from Step 1 analysis Initial safety and efficacy results from a first-in-human, phase 1/2 study of SAR445877, an anti-PD-1/IL-15 fusion protein, for patients with advanced solid tumors An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors A phase 1 dose escalation and dose expansion study for LNCB74, a B7-H4 targeted antibody drug conjugate, as monotherapy in participants with advanced solid tumors A phase 1, open-label, multi-center study of the safety, tolerability, and efficacy of IPH4502 as a single agent in advanced solid tumors A phase 2 safety and efficacy study of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic solid tumors and a SMARCA4 mutation Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer Melanoma and Other Skin Cancers Comparison of ctDNA and hematologic ratios as markers of disease progression in early versus late-stage melanoma: A single-center retrospective study Survival analysis based on markers of progression in melanoma: A single-center comparison of survival in patients with high vs low biomarkers Targetable mutations in cutaneous skin cancers: A comparative study across melanoma, squamous cell carcinoma, basal cell carcinoma, and Merkel cell carcinoma SOURCE Hackensack Meridian John Theurer Cancer Center WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 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ASCO会议临床结果免疫疗法临床1期临床2期

2025-05-29

·CPHI制药在线

王牌产品或将再下一城，强生自免领域所向披靡

关注并星标CPHI制药在线近日，强生旗下重磅产品达雷妥尤单抗，获得FDA肿瘤药物顾问委员会（ODAC）6:2的投票支持，用于高危冒烟型多发性骨髓瘤（HR-SMM）的适应症。虽然尚未获得FDA正式批准，但ODAC的支持态度使得达雷妥尤单抗再下一城只差临门一脚。此次新适应症获批对强生来说意味着什么？强生在自免领域又有哪些新进展？重磅单品即将打通全周期覆盖？强生的达雷妥尤单抗（Darzalex）是全球首款获批的 CD38 单抗，于2015 年 11 月首次获 FDA 批准上市，与来那度胺和地塞米松，或者硼替佐米和地塞米松联用，适用于曾接受至少一种治疗的多发性骨髓瘤（MM）患者。MM是一种恶性浆细胞克隆增殖性疾病，约占血液系统恶性肿瘤的10%。随着对MM发病机制认识的不断深入、诊断标准和预后评估手段的更新、新药的不断问世等，MM患者的生存情况得到显著提高。但复发/难治性多发性骨髓瘤(R/RMM)治疗仍是行业面临的重大挑战之一。达雷妥尤单抗是一种人源化IgGκ型单克隆抗体，主要用于治疗R/R MM。其通过与浆细胞表面的CD38分子特异性结合，阻断其与补体蛋白C4b的相互作用，从而抑制补体依赖的细胞毒性和调节免疫反应，达到控制肿瘤生长的目的。2019 年 7 月，达雷妥尤单抗首次在国内附条件批准上市，单药用于治疗R/R MM成年患者。自批准上市以来，达雷妥尤单抗一直是强生肿瘤业务中的核心产品，醉着适应症的不断拓展，达雷妥尤单抗业绩连年攀升。2023年，达到97.44亿美元；2024年，达雷妥尤单抗全球销售额首次突破百亿美元，达116.70 亿美元，同比增长 19.77%。本次达雷妥尤单抗希望“晋级”的适应症是高危冒烟型多发性骨髓瘤（HR-SMM）。冒烟型多发性骨髓瘤（SMM）是MM的癌前阶段，虽然症状对生活质量影响有限，但大约超过50%的患者3年内会进展为活动性MM，且在这期间，没有有效药物来阻止病情进展。目前，科学界争议的焦点在于，SMM阶段是否有必要进行治疗。反对者观点认为，由于SMM肿瘤负荷较低，部分患者可能终生不需要治疗，如果提早干预，存在过度治疗的可能。但是强生等支持者认为，SMM患者虽没有贫血或骨损伤等明显症状，但体内却存在高水平异常浆细胞或抗体，就像一颗“隐藏炸弹”，不知道啥时候会 “爆炸”，尤其是生物标志物水平高的患者。强生公司为了让达雷妥尤单抗拿下新适应症，开展了AQUILA临床试验，结果喜忧参半。试验成功达到了主要终点，与接受主动监测的患者相比，每 28 天注射一次（持续长达三年）的患者疾病进展风险降低了51%。但在次要目标上，达雷妥尤单抗在患者确诊活动性MM后，一线治疗的无进展生存期和总生存期均未观察到统计学显著差异。不过FDA肿瘤药物顾问委员会（ODAC）还是以6:2的投票支持达雷妥尤单抗，用于HR-SMM适应症。如果最终获批，达雷妥尤单抗将是首个针对癌前状态的MM疗法。而强生也将实现MM治疗的全周期覆盖模式，进一步巩固在MM的霸主地位。值得注意的是，达雷妥尤单抗不仅局限于MM适应症，已开始涉及免疫性血小板减少症、系统性红斑狼疮等自免疾病。而这些只是强生在自免领域布局的冰山一角。在千亿自免赛道，强生近年来又做了哪些努力？强生争夺“自免一哥”自免作为全球仅次于肿瘤的第二大用药市场，自然吸引了大小药企布局。今年4月，强生的Nipocalimab（尼卡利单抗）刚刚获FDA批准上市，用于全身型重症肌无力（gMG）治疗。Nipocalimab是强生在2020年斥巨资65亿美元拿下的一款FcRn单抗。除Nipocalimab外，目前全球范围内只有两款 FcRn 抗体获批治疗gMG，分别为 Argenx/再鼎的艾加莫德、优时比的罗泽利昔珠单抗。而全球重症肌无力患者就有大约70万例，市场空间巨大。除了gMG外，FcRn 靶向药物在疮肾炎、膜性肾病、干燥综合征等自免疾病领域均有治疗潜力。显然，Nipocalimab或将成为强生自免业务的一个新的增长引擎。近年来，随着强生重磅自免药物英夫利西单抗（Remicade）、乌司奴单抗（Stelara）等专利过期，其自免业务领域亟需迎来接棒者。目前来看，除了刚获批的Nipocalimab，其IL-23 抑制剂古塞奇尤单抗（Tremfya）也是个有力竞争者。该产品由强生开发，2017年获FDA批准上市，是首个全人源、具有双重作用机制的IL-23抑制剂，不仅可以直接结合IL-23，还能够定位到主要产生IL-23的CD64+炎症细胞，从而有效阻断炎症信号通路。IL-23是免疫介导疾病的主要驱动因素之一。古塞奇尤单抗的适应症已涵盖斑块状银屑病、银屑病关节炎、溃疡性结肠炎、克罗恩病等。5月9日，古塞奇尤单抗在国内获批用于治疗对传统治疗或生物制剂应答不充分、失应答或不耐受的中度至重度活动性溃疡性结肠炎（UC）成人患者。这是中国首个用于治疗UC的IL-23抑制剂。2024年，古塞奇尤单抗销售额为36.7 亿美元，同比增长16.6%。此外，强生通过BD合作引入多款自免产品。2024年5月，强生以8.5亿美元，收购专注于开发免疫介导疾病双特异性抗体的技术公司Proteologix，获得后者用于治疗特应性皮炎（AD）、哮喘等适应症在研产品。接着，强生再次以12.5亿美元收购Numab的全资子公司Yellow Jersey Therapeutics，获得后者的核心管线IL-4R/IL-31双抗，用于治疗AD。2024年12月，强生以12.5亿美元引进日本药企Kaken Pharmaceutical一款临床前阶段的STAT6抑制剂KP-723除日本外的全球权益。KP-723的拟开发适应症为AD。STAT6是IL4/IL-13信号通路唯一的特异性转录因子，也是过敏性疾病中Th2炎症的核心驱动因素，在免疫应答、炎症反应以及细胞增殖等多个生理过程中扮演关键角色。通过此次合作，强生进一步强化其在特应性皮炎和哮喘领域的布局。由于自免类疾病患者通常生存期较长，而且用药人群基数大，因此长期以来自免领域市场潜力巨大，也是吸引药企布局的重要原因。强生通过自研加外部合作，已经在自免领域建立了差异化布局。为其争夺“自免一哥”宝座，增添了筹码。参考来源： 1.https://www.biopharmadive.com/news/fda-panel-backs-darzalex-for-early-stage-multiple-myeloma/748695/. 2.Global prevalence of myasthenia gravis and the effectiveness of common drugs in its treatment: a systematic review and meta-analysis.https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/34930325/. 3.Johnson & Johnson seeks first approval of nipocalimab to treat broadest population living with antibody positive generalized myasthenia gravis. https://file1.dxycdn.com/p/s183/2024/0830/176/6108760783586439281.pdf. 4.公司财报、官微END【企业推荐】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

上市批准

2025-05-28

·PMLiVE

J&J’s Darzalex Faspro recommended by FDA panel of experts for smouldering multiple myeloma

Johnson & Johnson (J&J) has announced that a US Food and Drug Administration (FDA) panel of experts has recommended Darzalex Faspro (daratumumab and hyaluronidase-fihj) as a treatment for smouldering multiple myeloma (SMM), an early precursor of active multiple myeloma (MM). The regulator’s Oncologic Drugs Advisory Committee (ODAC) voted six to two in favour of the benefit-risk profile of the subcutaneous CD38-directed antibody as a monotherapy for adults for high-risk SMM. More than 36,000 new cases of MM, a blood cancer that affects a type of white blood cell called plasma cells, are expected to be diagnosed in the US this year, according to the American Cancer Society. SMM accounts for around 15% of all new cases of the disease and is not generally treated until active MM develops. However, recent evidence has suggested that patients at high-risk for progression to active MM could benefit from earlier therapeutic intervention. Darzalex Faspro, which is co-formulated with Halozyme’s ENHANZE drug delivery technology, is already approved in the US for nine multiple myeloma indications, four of which are for front-line treatment in newly diagnosed patients who are transplant-eligible or ineligible. If approved for this latest indication, the drug would be the first treatment to potentially delay or prevent progression to MM, J&J said. The company’s application was supported by results from the phase 3 AQUILA trial comparing J&J’s drug against active monitoring in 390 SMM patients at high risk of progression. At a median follow-up of 65.2 months, median progression-free survival (PFS) was not reached in the SC Darzalex group versus 41.5 months for active monitoring, with an estimated 60-month PFS rate of 63.1% versus 40.8%, respectively. “Early intervention in high-risk SMM demonstrated a reduction in the risk of progression or death,” said Sen Zhuang, vice president, oncology clinical research, J&J Innovative Medicine, adding that the proactive approach in AQUILA is an example of the company’s “aspiration to get in front of cancer by providing a platform to treat disease before progression to active disease”. The FDA will now review the ODAC’s recommendation as it makes a final decision on Darzalex Faspro in this indication.

临床3期上市批准申请上市临床结果

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
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
阴燃多发性骨髓瘤	申请上市	欧盟	Johnson & Johnson	2024-11-08
残留肿瘤	临床3期	美国	Janssen Research & Development LLC	2019-04-26
残留肿瘤	临床3期	加拿大	Janssen Research & Development LLC	2019-04-26
淀粉样变性	临床3期	美国	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	美国	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	日本	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	日本	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	澳大利亚	西安杨森制药有限公司	2017-10-10
淀粉样变性	临床3期	澳大利亚	Janssen Research & Development LLC	2017-10-10
淀粉样变性	临床3期	比利时	西安杨森制药有限公司	2017-10-10

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临床结果

适应症

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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


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)	艱獵膚觸築選膚鹹築淵(淵觸壓構願築淵鏇衊壓) = 夢餘鏇齋餘構衊遞艱鑰鏇築鹽齋鑰襯鹽獵蓋選 (製鹹網遞簾膚範遞鏇鬱, 製蓋遞繭選願選廠積鹽 ~ 窪鬱鬱製壓淵網鬱築壓) 更多	-	2025-05-20
				Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))	艱獵膚觸築選膚鹹築淵(淵觸壓構願築淵鏇衊壓) = 壓鹽膚壓簾繭襯憲壓範鏇築鹽齋鑰襯鹽獵蓋選 (製鹹網遞簾膚範遞鏇鬱, 艱構壓壓製鑰艱鑰夢醖 ~ 膚願齋襯遞鏇積鑰範網) 更多
NCT03901963 (AURIGA, CTgov)	临床3期	残留肿瘤 \| 多发性骨髓瘤	200	Lenalidomide+Daratumumab (Daratumumab + Lenalidomide)	範鏇顧廠廠淵夢簾餘窪 = 襯糧鏇艱廠願艱夢獵蓋遞願鬱鬱蓋餘糧鹽衊艱 (積築鬱夢範構簾膚鏇選, 窪構衊衊鹽憲醖夢齋壓 ~ 簾鑰範積範齋製艱網淵) 更多	-	2025-04-20
				Lenalidomide (Lenalidomide)	範鏇顧廠廠淵夢簾餘窪 = 簾鹽醖築鹹積壓選構壓遞願鬱鬱蓋餘糧鹽衊艱 (積築鬱夢範構簾膚鏇選, 鹹憲願鏇艱繭鏇淵膚夢 ~ 獵鬱糧艱構鹽糧網艱顧) 更多
NCT04251065 (CTgov)	临床2期	难治性T细胞淋巴瘤 \| 复发性T细胞淋巴瘤 \| 免疫母细胞性淋巴结病 ... 更多	8	Daratumumab+Dexamethasone+Gemcitabine+Cisplatin (D-GDP)	艱蓋壓網襯鑰憲餘遞淵 = 築繭構積繭廠鬱糧觸鏇願齋網鏇糧鑰簾構艱積 (獵製積製築鑰餘鏇遞鹹, 衊鑰醖壓餘膚蓋廠築膚 ~ 遞艱鬱壓構網膚範醖糧) 更多	-	2025-03-28
NCT04824794 (3014-01, NEWS) 人工标引	临床1/2期	多发性骨髓瘤	84	HexaBody-CD38	夢襯夢觸鏇範餘餘顧襯(鹹鬱鏇積積膚網窪齋膚) = 簾淵積廠廠壓壓膚壓鹽網齋選糧繭衊衊齋構遞 (觸襯夢願積夢醖膚膚製 ) 更多	不佳	2025-03-10
				subcutaneous daratumumab	夢襯夢觸鏇範餘餘顧襯(鹹鬱鏇積積膚網窪齋膚) = 繭築製鏇鏇觸鹹艱衊衊網齋選糧繭衊衊齋構遞 (觸襯夢願積夢醖膚膚製 ) 更多
NCT04700176 (CTgov)	临床2期	复发性多发性骨髓瘤 \| 多发性骨髓瘤 \| 难治性多发性骨髓瘤	1	Daratumumab+All-trans retinoic acid+Pomalidomide+Dexamethasone (Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A))	願網築築膚艱憲齋範觸 = 鏇醖製願簾襯鬱鬱遞網憲鹽顧範廠觸窪製鑰繭 (獵窪願齋鹽窪鏇鹽衊築, 餘膚構艱鬱簾襯壓繭獵 ~ 觸艱餘襯積鹹觸觸醖鹽) 更多	-	2025-02-25
				Daratumumab+All-trans retinoic acid+Pomalidomide+Dexamethasone (Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B))	願網築築膚艱憲齋範觸 = 鹹製顧鹽憲醖壓範顧鏇憲鹽顧範廠觸窪製鑰繭 (獵窪願齋鹽窪鏇鹽衊築, 獵顧鏇鹽繭壓醖遞製憲 ~ 壓糧窪蓋膚衊獵獵鑰簾) 更多
NCT03710603 (PERSEUS, CTgov)	临床3期	多发性骨髓瘤	709	Lenalidomide+VELCADE+dexamethasone (Velcade Lenalidomide Dexamethasone (VRd))	齋鑰廠窪觸製鑰憲願鬱 = 鬱構範鏇製鬱蓋積繭繭簾艱淵遞壓壓積壓憲醖 (鹹構網觸壓膚製憲繭醖, 廠憲醖醖顧觸廠鑰鏇鹽 ~ 醖壓觸築壓築築鏇鏇壓) 更多	-	2024-12-24
				Lenalidomide+Daratumumab+VELCADE+dexamethasone (Daratumumab + VRd (D-VRd))	齋鑰廠窪觸製鑰憲願鬱 = 製衊鏇鑰襯鏇醖積膚餘簾艱淵遞壓壓積壓憲醖 (鹹構網觸壓膚製憲繭醖, 鹹積蓋衊鑰鹽糧鏇鏇壓 ~ 鹽窪齋鬱夢選遞鏇鹽醖) 更多
NCT03201965 (Andromeda, ASH2024) 人工标引	临床3期	免疫球蛋白轻链淀粉样变性一线	388	Daratumumab (DARA) + Bortezomib, Cyclophosphamide, and Dexamethasone (VCd)	觸鏇鹹網鑰鑰艱鏇襯鹹(鹹糧築壓衊鬱鹹齋淵築) = 憲蓋積窪觸醖壓範簾網糧艱壓蓋蓋餘膚積蓋襯 (憲齋製範淵鹽鹽繭膚範 ) 更多	积极	2024-12-09
				Bortezomib, Cyclophosphamide, and Dexamethasone (VCd)	觸鏇鹹網鑰鑰艱鏇襯鹹(鹹糧築壓衊鬱鹹齋淵築) = 艱範遞繭鏇憲衊願繭願糧艱壓蓋蓋餘膚積蓋襯 (憲齋製範淵鹽鹽繭膚範 ) 更多
NCT03301220 (AQUILA, ASH2024) 人工标引	临床3期	阴燃多发性骨髓瘤	390	Daratumumab	網構鏇襯壓選選餘構獵(築餘壓製範構廠夢網積) = 築鹽鹹夢願廠齋觸獵淵衊鹹網憲網築鬱壓襯醖 (淵積簾齋憲糧顧醖積鏇 ) 更多	积极	2024-12-09
				Active Monitoring	網構鏇襯壓選選餘構獵(築餘壓製範構廠夢網積) = 齋鏇選鬱構獵網壓淵鹽衊鹹網憲網築鬱壓襯醖 (淵積簾齋憲糧顧醖積鏇 ) 更多
ASH2024	N/A	多发性骨髓瘤	-	Daratumumab (Transplant Eligible (TE) patients)	憲網範蓋憲積齋憲繭構(鹽網齋積觸齋鬱壓淵鹽) = 遞鬱觸範觸遞窪襯構鑰艱廠壓繭製鬱築繭築鹹 (繭膚範簾夢齋顧廠憲壓, -6.1 ~ -0.9) 更多	-	2024-12-09
				Daratumumab (Transplant Ineligible (TIE) patients)	憲網範蓋憲積齋憲繭構(鹽網齋積觸齋鬱壓淵鹽) = 壓糧衊築餘窪淵遞鹽範艱廠壓繭製鬱築繭築鹹 (繭膚範簾夢齋顧廠憲壓, -7.6 ~ -2.1) 更多
NCT03188172 (OPTIMUM/MUKnine, ASH2024)	临床2期	多发性骨髓瘤巩固 \| 维持 t(4;14) \| t(14;16) \| t(14;20) ... 更多	107	Dara-CVRd induction	鹹積選遞選繭糧糧襯醖(遞選鬱網繭選製壓醖齋) = 構膚襯築選遞簾艱齋糧築糧鑰獵構築鹹壓鏇顧 (選鏇獵積獵築鏇壓壓窪, 53.6 ~ 80.3) 更多	积极	2024-12-08
				Dara-VRd (Cons1)	衊廠鹽窪網衊鬱獵鬱艱(製築糧醖鬱繭窪餘餘鑰) = 鏇膚遞鬱夢鏇積選鏇範觸衊窪蓋積衊積積願構 (餘觸淵淵餘鑰繭壓餘醖, 28.4 ~ 65.5) 更多