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，难治性多发性骨髓瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Daratumumab (Genetical Recombination)、达拉图单抗、达雷木单抗

+ [7]

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难治性多发性骨髓瘤+ [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-Cilag International NV

西安杨森制药有限公司Janssen Research & Development LLC

+ [16]

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)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、孤儿药 (韩国)、优先审评 (日本)、孤儿药 (英国)、附条件批准 (中国)、优先审评 (中国)、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

350

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2026-06-28

申办/合作机构

The Children's Oncology Group Foundation, Inc.

NCT07341867

/ Not yet recruiting临床1期IIT

A Pilot Study of Duffy Null-Specific Dose Modifications for Individuals With Duffy Null Phenotype Receiving Standard of Care Systemic Anti-Cancer Therapies

This study is comprised of a main study, an observational study, and optional survey studies. The main study is being done to see whether using Duffy null specific treatment dosing guidelines can reduce or delay dose modifications and avoid neutropenic fever (fever in the setting of low neutrophils) for people with Duffy null phenotype receiving treatment for multiple myeloma or triple negative breast cancer. The observational study is to collect dose modification and neutropenic fever information on patients who do not have the Duffy null phenotype and receive the same standard of care regimens to see if there are differences in dose modifications and neutropenic fever between the two groups. The survey studies seek to understand general health experiences and preferences and experiences specific to people with Duffy null phenotype.
Study Drugs Include:
* Daratumumab
* lenalidomide
* bortezomib
* dexamethasone
* carboplatin
* paclitaxel
* pembrolizumab
* cyclophosphamide
* doxorubicin

开始日期2026-06-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

NCT07029776

/ Not yet recruiting临床2期IIT

A Phase 2 Study Exploring the Use of Bispecific Antibodies to Improve Progression Free Survival in Patients With High-Risk Newly Diagnosed Multiple Myeloma (MMulti-Immune HR)

The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM).
The treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.

开始日期2026-04-01

申办/合作机构

The University of Arkansas

[+1]

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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1,990

项与达雷妥尤单抗相关的文献（医药）

2026-12-31·ANNALS OF MEDICINE

Frequency-adjusted daratumumab-based regimen versus bortezomib/dexamethasone in newly diagnosed AL amyloidosis: a matched-cohort study

Article

作者: Li, Wenjing ; Zheng, Wanting ; Zhou, Meilan ; Liu, Baojian ; Zhao, Jin ; Xing, Yan ; Sun, Shiren

BACKGROUND:

The optimal dosing schedule for daratumumab (Dara) in newly diagnosed systemic light-chain (AL) amyloidosis requires refinement. This real-world study compared the efficacy and safety of a frequency-adjusted, cyclophosphamide-free Dara-based regimen with bortezomib/dexamethasone (BD).

METHODS:

We included newly diagnosed AL amyloidosis patients treated between January 2018 and December 2024, with follow-up data censored in August 2025. Using 1:1 propensity score matching based on age, cardiac stage, dFLC, and organ function, we compared hematologic/organ responses and survival. Survival was analyzed with Kaplan-Meier and log-rank tests. The Dara-based group received a cyclophosphamide-free regimen with an adjusted schedule (biweekly in cycle 1, then monthly) and a response-guided treatment duration.

RESULTS:

A total of 105 patients were included. After propensity score matching, 60 patients (30 per group) were selected for comparative analysis. The Dara-based group achieved significantly higher hematologic complete response (CR) rates at 6 months (57% vs. 27%, p = 0.018) and 12 months (63% vs. 27%, p = 0.002), with a markedly shorter median time to CR (61 vs. 120 days, p = 0.010). Organ responses were also superior: cardiac response 52% vs. 24% (p = 0.037) and renal response 56% vs. 27% (p = 0.037). No significant survival difference was observed during follow-up, and the safety profile was comparable between groups.

CONCLUSION:

A frequency-adjusted Dara-based regimen induces significantly faster and deeper hematologic and organ responses compared to BD in newly diagnosed AL amyloidosis which offers a promising personalized approach to reduce treatment burden and adverse events while maintaining high efficacy, supporting its integration into clinical practice for a broader patient population.

2026-02-04·JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY

Mass Spectrometric Exploration of Biclonal Gammopathy: Insights from a Diagnostic Laboratory

Article

作者: Ramaprasad, Sujay ; Ammalli, Prajwal ; Adinarayana, Champakalakshmi ; Puthiyaveettil, Ankitha K ; Putchen, Deepalakshmi D

Biclonal gammopathy is observed in approximately 1% of myeloma cases. Most current understanding of this condition is derived from incidental or anecdotal findings based on serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFE). The widespread use of therapeutic monoclonal antibodies (tmAbs), such as daratumumab, has introduced additional complexity, as these agents may appear as monoclonal bands on IFE, potentially interfering with accurate diagnosis. This study utilizes the enhanced sensitivity and molecular specificity of liquid chromatography-triple quadrupole mass spectrometry (LC-TQMS) to characterize biclonal patterns in patient sera. Over a 3.3-year period (January 2022 to April 2025), 124 cases initially reported as biclonal by IFE were reviewed, of which 85 samples were selected for LC-TQMS analysis following immunoglobulin enrichment using camelid antibodies targeting immunoglobulin isotypes and light chains. Released light chains, following reduction, were separated by liquid chromatography, and their molecular masses determined by TQMS. Among the isotype combinations, IgG-IgA was the most frequent (34.3%), followed by IgG-IgG (31.4%), while IgG-IgM and IgM-IgM combinations were each observed in 2.9% of cases. Regarding light chain patterns, κ-λ combinations were observed in 40% of cases, λ-λ in 25.7%, and κ-κ in only 5.7%, the latter likely reflecting tmAb interference. LC-TQMS analysis revealed biclonal patterns in 31.8%, monoclonal patterns in 52.9%, and tmAb interference in 9.4%. LC-TQMS demonstrated robust capability in resolving biclonality, including cases with or without coexistent free light chains, and in distinguishing analytical artifacts due to tmAb or conformational changes in immunoglobulin light chains that may mimic biclonal patterns on IFE. These findings underscore the importance of incorporating treatment history into IFE interpretation and support the implementation of LC-TQMS as an orthogonal method for resolving complex gammopathy profiles. A workflow is proposed to aid in accurate interpretation of biclonal cases.

2026-02-01·Blood neoplasia

Bone marrow immune cell composition reflects multiple myeloma progression and affects treatment response

Article

作者: Solimando, Antonio ; Azgomi, Mojtaba Shekarkar ; Pacelli, Paola ; Biondo, Marta ; Botta, Cirino ; Di Simone, Marta ; Sciortino, Miriam ; Cioffi, Francesca ; Dieli, Francesco ; Corsale, Anna Maria ; Raspadori, Donatella ; Brucato, Fulvio ; Caccamo, Nadia ; Beilhack, Andreas ; Gigliotta, Emilia ; Buffa, Francesca ; Aquilina, Cristina ; Zambello, Renato ; Siragusa, Sergio ; Cea, Michele ; Meraviglia, Serena ; Corsale, Giusy ; Gozzetti, Alessandro ; Tabares, Paula ; Bestoso, Elena ; Speciale, Maria ; Garofano, Francesca

The progression of multiple myeloma (MM) is characterized by intricate interactions between clonal plasma cells and the bone marrow (BM) microenvironment. In this study, we conducted a comprehensive analysis of BM immune cell composition spanning from premalignant stages to MM, using FlowCT, a semiautomated workspace empowered to analyze large data sets. Our cohort comprised 159 patients, covering monoclonal gammopathy of undetermined significance, smoldering MM, and MM, with most undergoing treatment with a daratumumab-based regimen. The evolving disease showed alterations in immune cell populations, including a reduction in the granulocyte-to-lymphocyte ratio (GLR) and granulocyte-to-T-lymphocyte (GTL) ratio, alongside an increase in T lymphocytes. Higher baseline levels of BM GLR and GTL ratio were associated with extended progression-free survival. Moreover, improved outcomes were observed in patients with a higher GTL ratio treated with daratumumab-based regimens. Furthermore, autologous BM-derived granulocytes enhance daratumumab-mediated cytotoxicity against primary autologous neoplastic plasma cells, unveiling a novel BM-granulocyte-dependent mechanism of action for daratumumab in patients with MM. These findings emphasize the dynamic nature of the BM immune compartment during MM progression and underscore the prognostic significance of immune cell composition in guiding therapeutic approaches and enhancing patient outcomes.

1,441

项与达雷妥尤单抗相关的新闻（医药）

2026-02-04

·drugs

FDA Approves Quadruplet Regimen for Adults With Newly Diagnosed Multiple Myeloma

WEDNESDAY, Feb. 4, 2026 -- The U.S. Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant (ASCT). D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of ASCT eligibility. The approval is based on the phase 3 CEPHEUS trial, which enrolled 395 patients. Results showed that at a median follow-up of 22 months, the overall minimal residual disease (MRD)-negativity rate at a sensitivity of 10 -5 (no cancer cells detected within 100,000 bone marrow cells) was 52.3 percent with D-VRd versus 34.8 percent with VRd alone. The proportion of patients achieving sustained MRD-negativity of ≥12 months almost doubled at a median follow-up of 39 months (42.6 versus 25.3 percent). D-VRd also significantly reduced the risk for progression or death (hazard ratio, 0.60) compared with VRd. At a median follow-up of 59 months, D-VRd significantly increased the depth of response, with higher rates of complete response or better observed versus VRd (81.2 versus 61.6 percent). "This approval marks the 12th indication for Darzalex Faspro overall and fifth in newly diagnosed multiple myeloma, underscoring its role as foundational therapy for both newly diagnosed and relapsed/refractory patients," June Lanoue, from Johnson & Johnson Innovative Medicine, said in a statement. "CEPHEUS demonstrated the efficacy of a Darzalex Faspro-based quadruplet as a frontline standard of care. With this approval, patients can receive D-VRd when they are first diagnosed with multiple myeloma, an important milestone as we work to one day deliver a functional cure." Approval of Darzalex Faspro was granted to Johnson & Johnson. More Information

临床结果临床3期上市批准细胞疗法加速审批

2026-02-03

·龙城医语

成人急性淋巴细胞白血病

一、重点概念（一）定义与本质特征急性淋巴细胞白血病（ALL）：淋巴系祖细胞（淋巴母细胞）克隆性增殖的异质性血液系统恶性肿瘤亚型分类：免疫表型：B 细胞型（B-ALL，75%~80%）、T 细胞型（T-ALL，15%~25%）分子遗传学亚型：Ph+ ALL、Ph 样 ALL、高超二倍体 ALL、低二倍体 ALL、ETV6-RUNX1 融合型、MLL（KMT2A）重排型等特殊亚型：早期 T 细胞前体 ALL（ETP-ALL）、伯基特淋巴瘤 / 白血病、治疗相关性 ALL（t-ALL）生物学特征：克隆性染色体易位（如 t (9;22)、t (12;21)）、基因突变（NOTCH1、IKZF1、TP53）、信号通路异常（JAK-STAT、PI3K/mTOR、MEK-ERK）（二）流行病学与病因学流行病学特征：儿童发病高峰（1~4 岁）、老年二次高峰（85 岁以上）、男性发病率略高（1.4:1）、发病率呈上升趋势病因学关键因素：遗传易感：唐氏综合征、布卢姆综合征等（<5% 病例）；多基因易感（GWAS 证实 8 个 SNP 位点：IKZF1、CDKN2A 等）环境因素：电离辐射（唯一明确危险因素）；饮酒、杀虫剂 / 溶剂接触、吸烟（相关性证据）致病机制：胎儿期白血病前期克隆形成（染色体易位）+ 后天感染 / 环境因素诱发显性白血病（感染源假说）（三）临床表现与实验室检查临床表现：全身性症状：乏力、贫血、血小板减少、发热、骨痛髓外受累：淋巴结 / 肝脾肿大、中枢神经系统（头痛、呕吐）、纵隔肿块（T-ALL 特征）、睾丸 / 乳腺受累关键实验室检查：基础检查：全血细胞计数（贫血、血小板减少常见）、乳酸脱氢酶（LDH）升高、高尿酸血症（肿瘤溶解风险）形态学检查：瑞氏-吉姆萨染色（淋巴母细胞特征：胞质稀少、无颗粒、核染色质模糊）、骨髓活检（增生活跃，原始细胞浸润）细胞化学染色：髓过氧化物酶（MPO）染色（ALL 均阴性，鉴别 AML）免疫表型：多色流式细胞术（B-ALL：CD19、CD79a、TdT 阳性；T-ALL：胞质 CD3、CD7、TdT 阳性）分子遗传学：染色体核型分析、FISH、RT-PCR（检测 BCR-ABL1 等融合基因）、RNA 测序 / 全基因组测序（四）诊断与鉴别诊断诊断标准：形态学 + 免疫表型确诊，细胞遗传学 + 分子遗传学辅助分型与风险分层中枢神经系统受累诊断：脑脊液白细胞 > 5/μL + 可见原始细胞鉴别诊断关键：与 AML 鉴别：MPO 染色、免疫表型（CD34、TdT 表达差异）与伯基特淋巴瘤鉴别：成熟 B 细胞表型（CD20 高表达、表面 IgM 阳性）、MYC 基因易位与反应性淋巴细胞增生鉴别：CD45 低表达 + TdT/CD34 阳性（ALL 特征）（五）预后评估标志物已明确危险因素：临床因素：年龄 > 60 岁、初诊 WBC 计数（B-ALL>30×10⁹/L，T-ALL>100×10⁹/L）、完全缓解时间 > 4 周遗传学因素：低二倍体（<44 条染色体）、MLL 重排、Ph+、复杂核型免疫表型：ETP-ALL、CD20 阳性预后标志物：微小残留病（MRD）—— 诱导 / 巩固治疗后 MRD 阴性者无事件生存率显著升高（儿童 77% vs 32%，成人 64% vs 21%）新兴危险因素：IKZF1 缺失、CRLF2 重排、JAK2 突变、Ph 样表型（六）治疗策略（分阶段+个体化）传统治疗三阶段：诱导缓解：糖皮质激素（泼尼松 / 地塞米松）+长春新碱+蒽环类+左旋门冬酰胺酶（药物），完全缓解率 84%~94% 缓解后治疗：巩固 / 强化化疗（hyper-CVAD 方案、大剂量甲氨蝶呤+阿糖胞苷）、维持治疗（POMP 方案，2~3 年）中枢神经系统预防：鞘内化疗（甲氨蝶呤 ± 阿糖胞苷）± 颅脑放疗移植治疗：异基因造血干细胞移植（allo-HSCT）：高危组、MRD 阳性者首选，供者优先 HLA 相合同胞 / 无关供者自体造血干细胞移植（auto-HSCT）：不推荐常规使用（疗效劣于化疗 /allo-HSCT）靶向治疗： Ph+ ALL：酪氨酸激酶抑制剂（TKI，伊马替尼 / 达沙替尼 / 普纳替尼）联合化疗，完全缓解率 90%+ Ph 样 ALL：JAK 抑制剂、ABL 抑制剂（针对 CRLF2 重排 / ABL 类融合）其他靶点：BCL2 抑制剂（维奈克拉）、PI3K/mTOR 抑制剂免疫治疗：双特异性抗体：博纳吐单抗（CD3/CD19）、伊珠单抗奥唑米星（CD22 抗体偶联药物） CAR-T 细胞治疗：靶向 CD19（替沙仑赛、布雷西珠单抗），复发 / 难治性 ALL 完全缓解率 71%~81% 特殊人群治疗：青少年 / 年轻成人：儿科强化方案（高剂量糖皮质激素+门冬酰胺酶），生存率 > 70% 老年患者：减低强度化疗 + TKI / 免疫治疗（博纳吐单抗），降低治疗相关毒性复发 / 难治性 ALL：CAR-T 细胞治疗、双特异性抗体、新一代 TKI（普纳替尼）（七）新型治疗与未来方向免疫治疗创新：双靶点 CAR-T（CD19/CD22）、异基因 CAR-T（UCART22）、CD38 单抗（达雷妥尤单抗，针对 T-ALL）靶向治疗新方向：Menin 抑制剂（针对 MLL 重排）、BH3 模拟物（维奈克拉+纳维托克拉斯）、表观遗传抑制剂（DOT1L 抑制剂）无化疗方案：TKI+免疫治疗（达沙替尼+ 博纳吐单抗）、低强度化疗+抗体药物（八）长期随访与并发症远期并发症：神经认知障碍、内分泌异常、骨坏死、心脏毒性、继发性恶性肿瘤随访指南：遵循《儿童、青少年和年轻成人癌症幸存者长期随访指南》，定期监测 MRD、器官功能二、总结1. 异质性是 ALL 的核心特征，贯穿诊断-治疗-预后全流程异质性体现：免疫表型（B/T 系）、分子遗传学（染色体易位 / 基因突变）、年龄分层（儿童 / 成人 / 老年）、治疗反应（MRD 转阴率）预后：不同亚型的生物学特征决定病因、预后差异，进而指导个体化治疗（如 Ph+ ALL 首选 TKI，ETP-ALL 需强化治疗）2. 分子遗传学是精准诊疗的 “核心” 发展脉络：诊断依据从 “形态学”→“免疫表型 + 细胞遗传学”→“分子遗传学（融合基因 / 突变）” 演进临床价值：① 分型：Ph 样 ALL、MLL 重排型等亚型的精准定义；② 靶向治疗：BCR-ABL1→TKI，CRLF2 重排→JAK 抑制剂；③ 预后分层：IKZF1 缺失→不良预后，ETV6-RUNX1 融合→良好预后3. MRD 是评估治疗效果与预后的 “金标准” 功能：比传统形态学缓解更精准，是预测复发、指导治疗调整（如 MRD 阳性者需 allo-HSCT）的关键指标技术趋势：从多色流式细胞术（灵敏度 10⁻⁴）向下一代测序（灵敏度 10⁻⁶）演进，实现更早复发预警4. 治疗模式从 “统一化疗” 向 “分层+靶向+免疫” 三位一体演进分层：基于年龄、MRD 状态、分子遗传学特征制定方案（低危→化疗，高危→allo-HSCT，老年→低强度+免疫）治疗：① 靶向药物显著改善高危亚型预后（Ph+ ALL 3 年总生存率从 15% 提升至 54%）；② 免疫治疗（CAR-T）突破复发 / 难治性 ALL 的治疗瓶颈；③ 无化疗方案成为老年 / 体弱患者的新选择5. 年龄是影响诊疗策略与结局的关键儿童 ALL：生物学特征更优（高超二倍体 / ETV6-RUNX1 融合比例高），儿科强化方案疗效显著（生存率近 90%）成人 ALL：不良遗传学特征比例高（Ph+、复杂核型），治疗需平衡疗效与毒性（化疗 + TKI / 免疫治疗）老年 ALL：耐受度低，优先选择减低强度化疗 + 靶向 / 免疫治疗，避免过度治疗6. 复发 / 难治性 ALL 的治疗核心是 “免疫 + 靶向” 的协同传统化疗疗效有限（二次完全缓解率 30%~40%），新型疗法实现疗效飞跃：双特异性抗体：博纳吐单抗总缓解率 44%，MRD 阴性率 88% CAR-T 细胞治疗：复发 / 难治性 B-ALL 完全缓解率 71%~81%，中位总生存期延长至 18.2 个月挑战：抗原逃逸（CD19 阴性复发）、治疗毒性（细胞因子释放综合征 / 神经毒性），需通过双靶点 CAR-T、异基因 CAR-T 解决7. 多学科协作与临床试验是提升生存率的关键诊疗模式：需血液科、病理科、放疗科、移植科协作，强调 “中心诊疗”（大型医学中心生存率更高）研究方向：① 早期干预：MRD 指导下的治疗调整；② 无化疗方案：TKI + 免疫治疗的联合应用；③ 罕见亚型：针对 MLL 重排、ETP-ALL 的特异性药物研发 ALL：以分子遗传学解析异质性，MRD 评估治疗深度，靶向+免疫治疗突破传统化疗局限，最终实现 “分型精准化、治疗个体化、预后可预测” 的目标。未来方向是进一步挖掘新型靶点、优化免疫治疗策略、推广无化疗方案，同时通过多中心临床试验验证罕见亚型的诊疗方案，缩小不同年龄层、不同亚型的生存率差距。

2026-02-03

·PMLiVE

Johnson & Johnson’s Darzalex Faspro regimen receives FDA approval for multiple myeloma

Johnson & Johnson has announced that its Darzalex Faspro-based regimen (daratumumab and hyaluronidase, in combination with bortezomib, lenalidomide and dexamethasone (D-VRd)), has received approval from the US FDA to treat adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The approval is based on results from the phase 3 CEPHEUS study, which compared the safety and efficacy of the D-VRd regimen with bortezomib, lenalidomide and dexamethasone (VRd) alone. Almost five years later, the Darzalex Faspro-based regimen showed significantly increased rates of complete response or better at 81.2% vs 61.6% with VRd. The study showed that the safety profile of the Darzalex Faspro-based regimen was favourable, with the most common adverse events including upper respiratory tract infection, sensory neuropathy and musculoskeletal pain. Multiple myeloma is a blood cancer affecting plasma cells. It is the second most common blood cancer globally. Estimates suggest that over 36,000 people will be diagnosed with multiple myeloma in the US, with over 12,000 deaths in 2026. Multiple myeloma has an average five-year survival rate of 59.8% and is currently incurable. Darzalex Faspro received approval from the FDA in May 2020, and is already approved for eleven indications in multiple myeloma. June Lanoue, US president, haematology at Johnson & Johnson, said: “This approval marks the twelfth indication for Darzalex Faspro overall and fifth in newly diagnosed multiple myeloma, underscoring its role as foundational therapy for both newly diagnosed and relapsed/refractory patients. “CEPHEUS demonstrated the efficacy of [D-VRd] as a frontline standard of care. With this approval, patients can receive D-VRd when they are first diagnosed with multiple myeloma, an important milestone as we work to one day deliver a functional cure.”

上市批准临床结果临床3期细胞疗法免疫疗法

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
难治性多发性骨髓瘤	欧盟	Janssen-Cilag International NV	2016-05-20
难治性多发性骨髓瘤	冰岛	Janssen-Cilag International NV	2016-05-20
难治性多发性骨髓瘤	列支敦士登	Janssen-Cilag International NV	2016-05-20
难治性多发性骨髓瘤	挪威	Janssen-Cilag International NV	2016-05-20
复发性多发性骨髓瘤	欧盟	Janssen-Cilag International NV	2016-05-20
复发性多发性骨髓瘤	冰岛	Janssen-Cilag International NV	2016-05-20
复发性多发性骨髓瘤	列支敦士登	Janssen-Cilag International NV	2016-05-20
复发性多发性骨髓瘤	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
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
淀粉样变性	临床3期	比利时	Janssen Research & Development LLC	2017-10-10

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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


NCT03301220 (AQUILA, CTgov)	临床3期	阴燃多发性骨髓瘤 \| 多发性骨髓瘤	390	daratumumab+rHuPH20	獵鬱範獵醖餘積淵遞壓(醖範築醖願觸獵壓觸夢) = 鑰網衊膚鏇廠壓鏇顧糧鏇鏇艱鏇獵遞鑰鏇簾構 (襯鏇艱構齋鑰鑰壓膚蓋, 淵製觸糧壓遞餘壓襯繭 ~ 鹽壓醖窪簾構壓壓鏇淵) 更多	-	2025-12-23
NCT03695744 (AMN006, Pubmed \| Leuk Lymphoma)	临床2期	多发性骨髓瘤一线	27	Daratumumab + Bortezomib + Dexamethasone	鬱糧艱艱廠鹹壓鬱鑰壓(獵醖獵糧鹽艱夢膚糧遞) = 鬱繭窪蓋鹹選獵構鏇夢製構獵簾獵範範網鹽鬱 (願築範簾夢鑰觸積糧獵 ) 更多	积极	2025-12-16
ASH2025	N/A	多发性骨髓瘤一线	21,978	Bortezomib-Lenalidomide-Dexamethasone (VRd)	餘鬱膚觸鬱觸鏇願憲窪(鏇鹽淵繭膚製廠鑰艱餘) = 願壓窪艱廠鑰鏇網壓廠願膚膚廠醖蓋夢構憲鹽 (衊網鹹網願遞簾鬱獵壓 ) 更多	不佳	2025-12-06
NCT04497961 (ASH2025)	临床3期	多发性骨髓瘤维持	89	Lenalidomide	積蓋鑰醖顧範選襯築鏇(鬱夢壓製願齋艱願製糧) = There was a significant increase in GHS per cycle (mean increase 0.18; 95%CI 0.11, 0.25) on maintenance. There was no difference in the primary endpoint of GHS between two arms (p=0.9). 繭製鏇積膚網壓製簾鹹 (艱簾鹽遞鑰窪夢繭積獵 ) 更多	积极	2025-12-06
NCT04497961 (ASH2025)	临床3期	多发性骨髓瘤维持	89	Daratumumab		积极	2025-12-06
NCT06409702 (ASH2025)	临床1期	多发性骨髓瘤	58	Daratumumab+Carfilzomib+Lenalidomide+Dexamethasone (DKRd)	網鹽憲齋淵觸積齋構窪(築積鹽襯鏇衊築繭簾鹹) = 鹹獵憲選積淵獵蓋窪鬱襯築鬱鏇築廠製鹹齋淵 (壓觸襯壓選築淵窪膚範 ) 更多	积极	2025-12-06
GEM-CESAR (ASH2025)	临床2期	阴燃多发性骨髓瘤	90	Daratumumab+ Pomalidomide +Dexamethasone (DPd)	醖築蓋憲鑰觸鏇壓襯觸(繭鬱簾壓蓋簾選觸蓋蓋) = 遞餘製範襯獵鏇艱製廠獵鹹構艱遞蓋製願網製 (顧願鏇積顧繭範鹽願願 ) 更多	积极	2025-12-06
ASH2025	N/A	多发性骨髓瘤	28	Subcutaneous Daratumumab	艱膚淵夢願鑰構膚鬱艱(鹹範艱襯構艱顧顧襯醖) = during and/or immediately after home administration, only one pt (3.6%) had adverse events (grade 2 allergic reaction according WHO), leading to dara permanent discontinuation. Main adverse events during the home management were infections (pneumonia in 4 pts, FUO in 1) 衊獵壓築鹹窪鹹淵鬱鏇 (獵觸觸襯簾糧醖顧艱鏇 ) 更多	积极	2025-12-06
ASH2025	N/A	多发性骨髓瘤	57	Daratumumab (cohort 1)	蓋遞遞範顧鏇製構網簾(蓋糧觸構鏇憲鹽淵積顧) = 醖餘齋廠窪簾顧憲醖衊壓廠鹹齋製憲餘獵鏇膚 (鏇築膚壓襯衊製壓廠構, 814 ~ 2847) 更多	积极	2025-12-06
ASH2025	N/A	多发性骨髓瘤	57	Daratumumab (cohort 2)	蓋遞遞範顧鏇製構網簾(蓋糧觸構鏇憲鹽淵積顧) = 選襯窪鏇鹹鏇鏇齋顧選壓廠鹹齋製憲餘獵鏇膚 (鏇築膚壓襯衊製壓廠構, 824 ~ 1488)	积极	2025-12-06
ASH2025	N/A	免疫球蛋白轻链淀粉样变性	9	Daratumumab+ Pomalidomide +Dexamethasone	蓋築鹹簾淵繭齋蓋構築(繭壓餘窪築鹹鏇觸餘鹹) = neutropenia in 3 patients (without associated infections) and anemia in 1 patient. 鏇鑰糧遞網鬱簾壓齋網 (窪願窪壓繭艱鹽壓積壓 ) 更多	积极	2025-12-06
NCT04474938 (ASH2025)	临床2期	免疫球蛋白轻链淀粉样变性	40	Daratumumab + Bortezomib + Dexamethasone	獵廠壓壓簾鹽鑰憲憲鏇(鬱選淵製壓網廠餘壓淵) = 觸餘淵範鹽構繭壓鬱簾範淵膚積鏇獵鹽選願築 (糧壓夢鹹糧鹹艱醖壓窪, 36.3 ~ 68.7) 更多	积极	2025-12-06