ELDORADO: a Randomized Phase II Trial of Elranatamab or Daratumumab in Combination With Lenalidomide, Bortezomib, and Dexamethasone (RVd Lite) in Newly Diagnosed, Transplant Ineligible/Deferred Multiple Myeloma

This research study is being done to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the combination of daratumumab, lenalidomide, bortezomib, dexamethasone for patients with newly diagnosed, transplant ineligible/deferred multiple myeloma.

开始日期2026-04-15

申办/合作机构

The Massachusetts General Hospital

[+1]

NCT07110844

/ Recruiting临床2期IIT

A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis

The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis.
The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.

开始日期2025-11-07

申办/合作机构

Columbia University

[+1]

NCT07075510

/ Recruiting临床1/2期IIT

A Phase I/II Study of Subcutaneous Daratumumab Administration in the Anterior Upper Thigh Vs Abdomen in Patients With Plasma Cell Disorders

The purpose of this study is to look at the safety, tolerability, and serum concentration of daratumumab administered subcutaneously in the thigh versus the abdomen in patients with plasma cell disorders. Daratumumab is a monoclonal antibody that can attach itself to the CD38 protein on the surface of abnormal plasma cells. Daratumumab can kill the abnormal plasma cells and/or help your immune system find and destroy them. Due to the way daratumumab works, normal cells may also be affected. All reference to the words "study drug" in this consent form will mean Daratumumab.
Daratumumab has been approved by the U.S. Food and Drug Administration (FDA) alone or in combination with other standard of care drugs for treatment of multiple myeloma in both subcutaneous (DARZALEX FASPRO®) and intravenous (DARZALEX®) ways of being delivered. The FDA has also approved the subcutaneous administration of daratumumab combined with other standard of care drugs for patients with light chain (AL) amyloidosis. Subcutaneous means the drug is given by an injection just beneath the skin. Intravenous (IV) means the drug is given as an injection directly into a vein.
Usually when given subcutaneously, the study drug is given by an injection in the abdomen. Having the drug given by subcutaneous injection (underneath the skin of the abdomen) has lessened the IV related side effects and the drug administration by injection is quicker.
However, some patients cannot receive the study drug injections in their abdomen because they find them very painful or have other medical reasons making it difficult to get these injections. The goal of this study is to see if getting the study drug subcutaneously, injected under the skin by a needle, in the patient's upper thigh will have the same results, or better results, as getting the injection in the abdomen. This would therefore, improve patients access to the drug and provide an alternative place to receive the injection of the drug.
This study will take place at University of Maryland Medical Center and there will be about 30 people who will take place in this study here. Dr. Badros is the Sponsor-Investigator of the study. Funding to conduct the study and study drug are being provided by Johnson & Johnson Innovative Medicine (J&J IM).

开始日期2025-10-23

申办/合作机构

University of Maryland Baltimore

[+1]

100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的临床结果

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100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的转化医学

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100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的专利（医药）

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项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的文献（医药）

2025-08-03·Therapeutic Delivery

May 2025 therapeutic delivery: industry update

作者: Harris, Elaine

This month saw approvals for two products employing Halozyme's Enhanze drug delivery technology (BMS's Opdivo and Johnson and Johnson's DARZALEX FASPRO®). A number of collaborations between industry partners and charities to fight the disease, including Duchenne muscular dystrophy and Epidermolysis Bullosa, have been announced. Successful clinical trial data was disclosed for products employing a wide variety of therapeutic delivery technologies including Perfuse Therapeutics intravitreal implant for glaucoma, Aspen Neurosciences precision delivery of an autologous dopaminergic neuronal precursor cell therapy for Parkinson's disease and Resurge Therapeutics IntraProstatic Drug Elution (IPDE) therapy for prostate cancer.

2024-10-01·ANNALS OF HEMATOLOGY

The clinical efficacy of a daratumumab-based regimen in relapsed/refractory acute leukemia: a single-center experience

Article

作者: Li, Jing ; Luo, Lin ; Dai, Yi ; Luo, Jun ; Cheng, Peng ; Wei, Zhenbin

Abstract:

Relapsed/refractory acute leukemia (R/R-AL) is associated with a low remission rate, short survival rate, and poor prognosis. Treating R/R-AL remains challenging as there is no standardized effective regimen; hence, there is a need for efficient therapies. CD38 expression has been observed in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Daratumumab is a humanized anti-CD38 monoclonal antibody used to treat multiple myeloma and has been reported to treat R/R-AL safely and effectively. The clinical data of 10 adult patients with R/R-AL who were treated with a daratumumab-based salvage regimen between July 2018 and May 2023 at our center were analyzed retrospectively. Seven AML and three ALL cases were included in the analysis. Seven (70%) patients showed responses to the treatments (complete response [CR], 60%; partial response [PR], 10%). Of the seven responders, three underwent allogenic stem cell transplantation (ASCT), including one who underwent a second ASCT. Among the five patients with R/R AML who had prior exposure to venetoclax, three achieved a therapeutic response (two CR and one PR) when re-treated with venetoclax in combination with daratumumab. The median follow-up time was 6.15 months (0.9–21 months). Overall survival and event-free survival rates at 12 months were 68.6% and 40.0%, respectively. The main adverse events included grade 3 febrile neutropenia (20%) and grade 3 hematological toxicities (60%). The daratumumab-based salvage regimen offers patients with R/R-AL the opportunity of remission with acceptable tolerability, creating the possibility of bridging ASCT.

2023-06-01·Clinical pharmacokinetics

Clinical Pharmacokinetics and Pharmacodynamics of Daratumumab

Review

作者: Kim, Kyeongmin ; Phelps, Mitch A

Daratumumab is a fully human, monoclonal immunoglobulin G1 and a first-in-class CD38-targeting drug approved by the US Food and Drug Administration for the treatment of patients with relapsed/refractory and newly diagnosed multiple myeloma or newly diagnosed light-chain amyloidosis. CD38 is heavily expressed on malignant myeloma cells, and daratumumab exerts anti-myeloma activity via immune-mediated mechanisms, direct induction of apoptosis, and immunomodulation. Daratumumab is used as monotherapy or in combination with standard-of-care myeloma therapies, including proteasome inhibitors, immunomodulatory agents, DNA-alkylating agents, and corticosteroids. Following an intravenous infusion, daratumumab exhibits nonlinear pharmacokinetics (PK), as clearance decreases with higher doses and over time because of target-mediated effects. Dosing schedules vary depending on indications and co-administered drugs, but generally daratumumab is administered weekly for 6-9 weeks followed by a less frequent dosing regimen, once every 2-4 weeks. Daratumumab exposure is strongly correlated with efficacy, and the exposure-efficacy relationship follows a maximal effect model, whereas exposure is not correlated with safety endpoints. The approved dose of 16 mg/kg of daratumumab results in the saturation of 99% of the target at the end of weekly dosing in most patients, and high target saturation is maintained over time during the less frequent dosing schedule. Infusion-related reactions are frequently observed in patients given daratumumab, particularly with the first infusion, thus prompting long durations of infusion (~ 7 h) and splitting of the first dose across 2 days. This led to the development of a subcutaneous delivery formulation for daratumumab (Dara-SC). Dara-SC provides a similar efficacy and safety profile to intravenous daratumumab (Dara-IV) but has a much lower rate of infusion-related reactions and a shorter infusion time. Exposure-response relationships for efficacy and safety endpoints were similar between Dara-SC and Dara-IV, and co-administered drugs with either Dara-IV or Dara-SC do not significantly affect daratumumab PK. Except for baseline myeloma type and albumin level, none of the other investigated disease and patient characteristics (renal/hepatic function, age, sex, race, weight, Eastern Cooperative Oncology Group performance status) was identified to have clinically relevant effects on exposure to daratumumab monotherapy or combination therapy regimens. Dara-IV exposure was significantly lower in patients with immunoglobulin G myeloma compared with patients with non-immunoglobulin G myeloma (p < 0.0001) and in patients with a lower albumin level, whereas the overall response rate was similar regardless of the myeloma type and albumin level. Daratumumab dose adjustment is not currently recommended based on disease and patient characteristics.

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项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的新闻（医药）

2026-02-04

·凯石新药试验

PFS率为71.0%，西达基奥仑赛让多发性骨髓瘤患者长期获益

在2025年美国血液学会（ASH）年会上，西达基奥仑赛（cilta-cel）对比标准治疗复发/难治性多发性骨髓瘤（RRMM）患者的长期无进展生存期（PFS）获益的结果[1]。在CARTITUDE-4研究中，研究人员随机将患者分为接受cilta-cel组和标准治疗组。标准治疗组接受泊马度胺、硼替佐米和地塞米松（PVd）或达雷妥尤单抗、泊马度胺和地塞米松（DPd）方案。Cilta-cel组患者先接受外周血单个核细胞采集和桥接治疗【方案为 PVd（泊马度胺 + 硼替佐米 + 地塞米松）或 DPd（达雷妥尤单抗 + 泊马度胺 + 地塞米松）】，随后接受环磷酰胺联合氟达拉滨的淋巴细胞清除预处理方案，最后进行单次 cilta-cel 输注。在CARTITUDE-4研究的意向治疗（ITT）人群中，中位随访时间33.6个月时，cilta-cel组（N=69）标准风险患者的30个月无进展生存期（PFS）率为71.0%，而标准治疗组（N=70）为43.2%。在实际治疗人群（N=59）中，标准风险患者的30个月PFS率为80.5%。在CARTITUDE-4的实际治疗标准风险人群中，26例患者在 cilta-cel 输注后12个月达到了微小残留病灶（MRD）阴性的完全缓解（CR），这些患者在30个月时的PFS率高达100.0%。多发性骨髓瘤介绍多发性骨髓瘤是一种浆细胞恶性增殖性疾病，骨髓中的浆细胞异常增生，通过分泌大量单克隆免疫球蛋白（M蛋白）导致靶器官功能损害。该疾病约占血液系统恶性肿瘤的10%，是血液系统第二大肿瘤，临床上主要表现为胸、腰、背部疼痛、高钙血症、贫血等[2]。随着多发性骨髓瘤治疗方法不断发展，单克隆抗体、蛋白酶体抑制剂、免疫调节药物、细胞疗法等的使用大大提高了患者的总生存期及无进展生存期。但目前多发性骨髓瘤仍为无法治愈的疾病，多数患者仍面临疾病复发风险[3]。根据《中国多发性骨髓瘤诊治指南（2024年修订）》的建议，多发性骨髓瘤复发后再诱导治疗方案选择流程图如下[4]：注：V为硼替佐米；d为地塞米松；K为卡非佐米；P为泊马度胺；I为伊沙佐米；S为塞利尼索；C 为环磷酰胺；R 为来那度胺；Apo 为埃普奈明；CAR‑T 为嵌合抗原受体 T 细胞；BiTE为双特异性抗体；a目前中国大陆地区上市的CAR‑T包括：伊基奥仑赛、泽沃基奥仑赛、西达基奥仑赛；b目前中国大陆地区上市的BiTE为特立妥单抗。目前国内有多个多发性骨髓瘤临床试验进行中，招募患者免费参加。 1、KQ-2003 CAR-T临床试验进行中在CDE官网显示[5]，评价 KQ-2003 CAR-T 细胞在复发/难治性多发性骨髓瘤患者的安全性、耐受性、初步有效性和药代动力学特征的I/IIa 期临床研究正在进行中，招募多发性骨髓瘤患者参加，若有需要，可咨询医学部老师。 KQ-2003是科弈药业自主创新研发核心技术增强型双靶CAR-T平台，研发的首个并联增强型结构双靶CAR-T，通过并联结构设计和信号域优化，显著提升CAR-T细胞的持久性与抗肿瘤活性，同时降低传统CAR-T的复发风险。重点针对复发/难治性多发性骨髓瘤（rrMM）（伴髓外）及POEMS综合征，能同时靶向B细胞成熟抗原（BCMA）和CD19两个治疗靶点[6-7]。在2024年第66届美国血液学会(ASH)年会上，公布了BCMA/CD19双靶CAR-T疗法在复发性、难治性多发性骨髓瘤患者（含髓外病灶转移患者）中的I/II期研究数据[8]。在23例接受KQ-2003治疗的患者中，5例患者无血液学可测量指标，其余18例患者均得到有效缓解，总缓解率（ORR）高达100%（18/18），其中实现严格的完全缓解（sCR）／完全缓解（CR）率为88.9%（16/18），治疗后达到了非常好的部分缓解（VGPR）率为11.1%（2/18）。在19例可评估微小残留病灶（MRD）的患者中，100%为MRD阴性，6个月和12个月时的MRD阴性率分别为80.0%（8/10）和100.0%（3/3）。 2、SG301联合泊马度胺、地塞米松临床试验进行中在CDE官网显示[5]，一项评价SG301注射液联合泊马度胺和地塞米松对比安慰剂联合泊马度胺和地塞米松治疗复发/难治性多发性骨髓瘤有效性和安全性的随机、对照、双盲、多中心Ⅲ期临床试验正在进行中，招募复发/难治性多发性骨髓瘤患者参加，若有需要，可咨询医学部老师。 SG301注射液是杭州尚健生物技术有限公司自主研发的抗CD38人源化单克隆抗体，具有独特抗原识别表位和差异化的作用机制，在临床前多种血液肿瘤模型中展现出良好的抗肿瘤活性[9]。 3、QL2109联合泊马度胺、地塞米松临床试验进行中在CDE官网显示[5]，比较QL2109或DARZALEX FASPRO®（达雷妥尤单抗注射液）分别联合泊马度胺、地塞米松治疗复发性或难治性多发性骨髓瘤患者的有效性和安全性随机、双盲、多中心III期临床研究正在进行中，招募多发性骨髓瘤患者参加，若有需要，可咨询医学部老师。 QL2109是齐鲁制药研发的达雷妥尤单抗生物类似药。达雷妥尤单抗是一种人源化IgG1κ型抗CD38单克隆抗体，为首个获批用于多发性骨髓瘤（ＭＭ）治疗的抗CD38单克隆抗体药物[10-11]。凯石招募——临床试验招募平台肿瘤患者申请参加临床试验须知：参与临床试验的患者，可以免费用试验新药，与试验相关的检查也是免费的。目前有CAR-T、TIL等细胞疗法，PD-1/PD-L1等免疫治疗药物，小分子抑制剂、双抗、单抗、ADC等靶向药物的临床试验正在进行中。正在招募肺癌、食管癌、肝癌、胃癌、结直肠癌、宫颈癌、卵巢癌、乳腺癌、胆管癌、子宫内膜癌、黑色素瘤、肉瘤、恶性血液疾病、淋巴瘤等各种恶性肿瘤，想要了解或者参加临床试验项目，可以咨询我们医学部的老师。企业商务合作请联系：13220157050 👉点击上面公众号名片关注我们👈 参考文献： 1.Luciano Costa, Albert Oriol, Dominik Dytfeld,et al.Long-term progression-free survival benefit with ciltacabtagene autoleucel in standardrisk relapsed / refractory multiple myeloma.[J]. 2025 ASH. 2.安永超，王金霞，袁艳玲等.多发性骨髓瘤的最新药物治疗及用药护理进展[J]．循证护理 2025 年 4 月第 11 卷第 7 期（总第 147 期）：1302-1307. 3.杨满，黄琰，张灵秀等.泊马度胺为主方案治疗复发难治性多发性骨髓瘤的临床效果研究[J]．中国实验血液学杂志 2025，33（2）：431-436. 4.中华医学会血液学分会.中国多发性骨髓瘤诊治指南（2024年修订）[J]．中华内科杂志 2024 年12 月第 63 卷第 12 期：1186-1195. 5.国家药品监督管理局药品审评中心（CDE）官网. 6.科弈药业双靶CAR-T疗法KQ-2003再次达成授权合作,科弈药业官方微信公众号，文章发布于2025年9月28日. 7.科弈药业KQ-2003增强型双靶CAR-T最新临床研究成果入选2024年美国血液学会（ASH）年会报告,科弈药业官方微信公众号，文章发布于2024年11月6日. 8.Hua Jiang, Lu Li1, Kaili Chen,et al.A prospective Investigator-Initiated Phase 1/2 Study of BCMA/CD19 Dual-Targeting CAR T Therapy in Patients with Relapsed/Refractory Multiple Myeloma Including Those with Extramedullary Disease.[J]. 2024 ASH. 9.尚健生物创新药SG301注射液 III期临床研究完成首例受试者给药，尚健生物官方微信公众号，文章发布于2024年06月15日. 10.齐鲁制药招募复发难治性多发性骨髓瘤患者，齐鲁制药集团微信公众号，文章发布于2025年9月23日. 11.沈恺妮，李剑.抗ＣＤ３８单抗治疗复发／难治性多发性骨髓瘤的临床研究进展[J]．临床肿瘤学杂志２０２５年８月第３０卷第８期：824-829.

免疫疗法细胞疗法临床结果ASH会议

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

·HPC药闻药事

HPC Intelligence│FDA法规动态 2026/01/16-01/29 FDA披露2025年成绩单，罕见病是重点，审评加速是亮点

「FDA法规动态」是对过去2周内FDA的重要新闻和法规动态的汇总。本专题重点关注与新药相关的获批、指南更新、研讨会和培训以及FDA其他重要新闻等。新药审评动态 DARZALEX FASPRO（daratumumab and hyaluronidase-fihj in combination with bortezomib, lenalidomide, and dexamethasone (VRd)）产品类别：靶向CD38的单克隆抗体开发公司：Janssen Biotech, Inc. 批准类型：生物制品许可申请（BLA）SUPPL-28- Efficacy 获批时间：2026年1月27日本次适应症：治疗不适合接受自体干细胞移植(ASCT)的新诊断多发性骨髓瘤成人患者既往适应症： Darzalex Faspro最早于2020年5月获得FDA批准，获批用于治疗多发性骨髓瘤的11种适应症，其中5种适应症为新诊断患者的一线治疗，无论患者是否适合移植。 FDA政策应用：评估辅助工具（Assessment Aid）指南更新 M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality-Draft 指南名称：M4Q(R2)《人用药品注册通用技术文件：质量部分》-草案发布日期：2026年1月20日简要介绍：本次指南对通用技术文件（CTD）的质量部分进行了修订，以进一步提高注册及生命周期管理效率，促进数字化转型和知识管理，并支持新兴技术的相关条款。 Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval-Draft 指南名称：多发性骨髓瘤中的微小残留病与完全缓解：作为支持加速批准审批的终点指标-草案发布日期：2026年1月21日简要介绍：该指南为申办方提供了关于使用多发性骨髓瘤微小残留病（MRD）和完全缓解（CR）作为临床试验主要终点的建议，以支持加速批准。适用范围：旨在评估治疗多发性骨髓瘤的药物和生物制品。研讨会和培训 Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks 会议主题：促进儿科治疗药物研发（ADEPT）第十期：应对新生儿产品开发挑战——借鉴罕见疾病研发框架举办时间：美东时间2026年2月5日-2月6日会议目的：本次研讨会旨在探讨新生儿与罕见疾病产品开发中的共性问题，并寻求在新生儿产品研发领域中应用罕见疾病产品开发框架的可行路径。重要新闻和动态 FDA Reports Lack of Interest, High Rejection Rate for Its STAR Program 近日，FDA表示申办方对参与“分段实时申请审查”（STAR）试点项目的兴趣极小。STAR项目依据《处方药用户付费法案》（PDUFA VII）设立，旨在通过允许"分阶段提交数据"及"提前启动审评"的方式，加速针对未满足临床需求疗法的患者可及性。该项目虽已开放所有治疗领域，但自2022年10月启动至2025年9月，仅收6份申请且全部被拒，至今无成功进入审评的案例。申请被拒主要原因包括：未能证明相比现有疗法具有临床终点的实质性改善、未针对存在未竟医疗需求的严重疾病，以及申请材料存在需延长审评的复杂问题。 FDA表示该项目拓展至涵盖新药上市申请（NDAs）和生物制品许可申请（BLAs）的努力并未获得成功，因为FDA还未收到任何针对原始上市申请的STAR计划的正式请求。行业调研显示，虽然65%的企业有所兴趣，但普遍面临实施障碍。在肿瘤药领域，67%的企业更倾向于选择“实时肿瘤审评（RTOR）”项目。FDA坦言，由于缺乏实际案例，无法评估该项目的实际效果与影响。尽管反响冷淡，FDA仍决定将项目延续至2027年9月，最终去留将在下一轮PDUFA谈判中决定。这一情况反映出监管创新与行业需求之间的落差，以及企业在加速审评路径选择上的审慎态度。 Makary’s priorities: Faster reviews, domestic manufacturing, and AI FDA局长Marty Makary近期强调，应在针对美国国家安全关键药物的“局长国家优先审评券（CNPV）”中注入类似“曲速行动（Operation Warp Speed）”的紧迫性，以加速审评流程，特别是推动CMC部分与临床试验同步审核，从而打破新药上市耗时十年的传统模式。尽管CNPV计划因可能弱化科学标准而引发内部及业界伦理性质疑，且近日FDA出于安全性考虑已推迟CNPV计划内两款药物的审评（赛诺菲糖尿病药物Tzield是由于收到包括死亡案例在内的不良事件报告被延期；Disc Medicine血液疾病治疗药物bitopertin则因审评员对试验数据及滥用风险的担忧推迟审评），但FDA整体致力于通过流程重构与技术赋能，在保障安全的前提下系统性提升监管效率，回应公众对创新疗法的迫切需求。同时，FDA计划于今夏确定首批入选预检查（Precheck）计划的企业，通过增强监管可预测性引导制药产能回归美国本土。在技术层面，FDA正依托人工智能助手ELSA将申请初审从60天压缩至一天，并借助计算毒理学模型及器官芯片等新方法替代部分动物试验，有望缩短研发周期6至9个月。 FDA Announces PreCheck Implementation Roadmap 2026年2月1日，FDA正式启动了预检查（PreCheck）试点计划的申请受理工作。PreCheck计划旨在通过提升监管可预测性、推动制药生产基地在美国本土建设、以及在特定产品申请前简化制药生产场地设施的评估流程，从而强化美国国内药品供应链体系。FDA官网已公布了详细的申请资格标准、遴选条件、提交细则，以及企业通过参与本项目可预期获得的效益。资格标准包括：申请场地必须是位于美国本土或属地、已（或即将）破土动工的全新药品/生物制品生产场地，且其生产规模需足以满足特定市场需求（满足罕见病需求的小批量生产也可接受）或能显著缓解美国市场供应压力。参与企业需承诺在试点期间为该场向FDA提交一份初始的NDA、ANDA、BLA、相关补充申请或II类DMF，并保证在该场地生产的产品获批后，至少持续投产三年。每家企业仅限申请一个场地。遴选规则：Precheck计划第一阶段将根据与美国国家优先战略的整体契合度甄选首批新建制药生产场地设施，评估维度包括：计划生产的产品类型、设施建设阶段、面向美国市场投产的时间规划，以及设施建设过程中的创新性表现。提交规则：企业在3月1日前提交申请，FDA将于4月1日前选定Precheck计划入围者并告知企业需补充的信息；入围企业在5月1日前提补充信息；FDA审核最终提交材料并在6月30日前确定最终入选名单；7月1日与预检查试点计划初始队列开始投产前接洽。更多内容可查看官网信息： https://www.fda.gov/industry/fda-manufacturing-precheck-pilot-program Novel Drug Approvals for 2025 FDA近日发布了《2025年新药治疗审批报告》，其中指出去年共批准了46种新药，其中33种采用了加速审批程序。报告同时显示，FDA还批准了18种生物类似药，其中包含针对3种新参照药的4款生物类似药。更多审批内容可至官网查看报告： https://www.fda.gov/media/190705/download?attachment FDA warns HIV test distributors, supplement firm, and OTC drugmaker FDA近期公布了多封警告信，主要涉及三类违规行为：未经许可销售艾滋病诊断试剂盒、未经批准开展临床试验以及违反现行药品生产质量管理规范（CGMP）。未经授权销售艾滋病自检试剂盒 FDA向Genovate.com、Genetrace.com、ProDx Health和Germaphobix四家企业发出警告信，指出其销售的艾滋病血清学诊断干血斑（DBS）自收集试剂盒未获得上市许可。FDA强调，这些产品既非实验室自建检测方法（LDT），也未经安全性及有效性验证，擅自销售属于违法行为。Germaphobix辩称其仅为分销商，但FDA明确回复该试剂盒不属于LDT范畴。FDA特别指出，自检操作存在样本采集规范性、运输稳定性及检测时效性等多重风险，并提醒公众可选择已获批的非处方艾滋病检测产品。未经IND批准开展临床试验 FDA对加州公司Prodrome Sciences发出了警告信，因在未获得新药临床试验（IND）批准的情况下，开展了营养补充剂ProdromeNeuro Oil（Omega-3缩醛磷脂）针对轻度至中度痴呆患者的临床研究，且已在2020年7月至2021年3月期间招募了29名受试者。该公司在书面回复FDA现场检查438表中辩称该产品为天然膳食补充剂不受IND监管，但FDA依据《食品、药品和化妆品法案》第201(g)(1)条指出，判断产品是否属于药品取决于临床研究目的而非成分来源。该研究未提交IND申请的行为已对受试者安全及数据有效性构成风险。虽然公司承诺整改且提供了纠正和预防措施计划概述，但FDA认为并不充分，未能提供未来避免类似违规的详细规划。FDA要求该公司在收到警告信后的15个工作日内，书面告知FDA为防止未来类似违规行为所采取的措施，否则，FDA将可能采取监管行动。违反CGMP生产规范圣路易斯非处方药企业Integrity Partners Group因多次违反CGMP收到警告信，具体问题包括：未建立完善的成品检测方法，无法确保产品符合最终质量标准；未对原材料进行充分鉴别检验；生产设备清洁维护程序存在缺陷；缺乏工艺及系统验证流程。尽管企业承诺委托第三方实验室完善检测流程，但FDA认为其回应未提供符合美国药典（USP）标准的具体措施，且质量体系存在系统性缺陷，建议聘请CGMP顾问进行全面整改。FDA特别强调，合同生产企业需对药品质量承担主体责任，不能通过协议转移监管责任。关于汉佛莱美国汉佛莱医药顾问有限公司是一家专业为医药工业提供高端法规服务的咨询公司。从2003年的美国马里兰，到2012年的中国南京，汉佛莱逐步建立起以药品法规为核心，以药品注册、产品开发与合规、商业开发和项目管理为支柱的服务体系。汉佛莱专注过程，承诺结果，认真扎实，伴随中国医药企业成长，为中国医药国际化努力奉献自己的一份力量。联系方式：400-096-2698 电子邮箱：hpc@humphriespcc.com 声明：本文内容部分源于FDA官网信息，中文翻译仅代表HPC观点，如有意见或想法，欢迎联系我们或留言，感谢。

100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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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	美国	Johnson & Johnson	2025-11-06
阴燃多发性骨髓瘤	美国	Janssen Biotech, Inc.	2025-11-06
免疫球蛋白轻链淀粉样变性	美国	Janssen Biotech, Inc.	2021-01-15
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2020-05-01
难治性多发性骨髓瘤	澳大利亚	Janssen-Cilag Pty Ltd.	2017-07-17
复发性多发性骨髓瘤	澳大利亚	Janssen-Cilag Pty Ltd.	2017-07-17

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
意义不明的单克隆丙种球蛋白病	临床2期	美国	Janssen LP	2025-09-26
前体T淋巴细胞白血病淋巴瘤	临床2期	美国	Janssen LP	2023-05-25
残留肿瘤	临床2期	美国	Janssen LP	2023-05-25
急性髓性白血病	临床1期	美国	Janssen Research & Development LLC	2024-09-19
成人急性淋巴细胞白血病	临床1期	美国	Janssen Research & Development LLC	2024-09-19
再生障碍性贫血	临床1期	美国	Janssen Research & Development LLC	2024-09-19
骨髓移植排斥反应	临床1期	美国	Janssen Research & Development LLC	2024-09-19
慢性粒细胞性白血病	临床1期	美国	Janssen Research & Development LLC	2024-09-19
霍奇金淋巴瘤	临床1期	美国	Janssen Research & Development LLC	2024-09-19
骨髓增生异常综合征	临床1期	美国	Janssen Research & Development LLC	2024-09-19

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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


NCT05083169 (MajesTEC-3, ASH2025) 人工标引	临床3期	难治性多发性骨髓瘤	587	Teclistamab + Daratumumab	襯糧夢廠廠淵範製蓋窪(觸餘鹹膚糧積艱簾鏇鹽) = 壓膚夢範範網構獵衊鏇齋夢鑰觸鑰襯醖夢淵廠 (鬱淵鏇襯艱選遞範鹹蓋 ) 更多	积极	2025-12-09
				Daratumumab + Dexamethasone + either Pomalidomide or Bortezomib	襯糧夢廠廠淵範製蓋窪(觸餘鹹膚糧積艱簾鏇鹽) = 廠衊獵窪窪鏇願齋憲鹽齋夢鑰觸鑰襯醖夢淵廠 (鬱淵鏇襯艱選遞範鹹蓋 ) 更多
NCT05511428 (CTgov)	临床4期	多发性骨髓瘤	20	Interview+Daratumumab and Hyaluronidase-fihj	遞構構餘積遞選淵醖鹹(餘醖淵築製鑰鑰網鑰積) = 網鹹選範夢遞構蓋獵選築壓憲鬱齋製繭窪蓋醖 (鹽鏇壓鹽繭遞鑰糧餘衊, 10.5) 更多	-	2025-11-21
NCT05083169 (MajesTEC-3, Company_Website) 人工标引	临床3期	多发性骨髓瘤二线 \| 末线 \| 三线	-	Daratumumab Injection（Subcutaneous Injection）+Teclistamab	積襯遞顧鑰築繭構壓網(遞觸艱憲餘膚製簾簾糧) = Reaching the endpoint 夢願糧糧鏇築淵壓鹹鏇 (獵鬱廠蓋憲願衊鹹鏇範 ) 达到更多	积极	2025-10-16
				standard of care
NCT03652064 (CEPHEUS, ASCO2025) 人工标引	临床3期	多发性骨髓瘤一线 HRCA del(17p) \| HRCA t(4;14) \| HRCA t(14;16) ... 更多	395	Daratumumab + bortezomib + lenalidomide + dexamethasone (HiR)	鑰鏇廠獵蓋繭構艱衊願(鏇夢簾憲鏇鏇構鹹製願) = 鹹簾糧積鹽範壓繭壓鏇鏇顧糧鑰淵簾構艱獵糧 (積鏇鹹窪鹹襯鑰淵選範 ) 更多	积极	2025-05-30
				Bortezomib + lenalidomide + dexamethasone (HiR)	鑰鏇廠獵蓋繭構艱衊願(鏇夢簾憲鏇鏇構鹹製願) = 鹹餘製獵齋憲願鏇艱蓋鏇顧糧鑰淵簾構艱獵糧 (積鏇鹹窪鹹襯鑰淵選範 ) 更多
NCT03710603 (PERSEUS, ASCO2025 \| PRNewswire) 人工标引	临床3期	多发性骨髓瘤一线	709	daratumumab+bortezomib+lenalidomide+dexamethasone (Achieved sustained (≥12 mo) MRD neg (10^-5))	鏇膚鏇醖獵襯襯糧築淵(淵製顧鑰鬱鹹獵鏇鏇鹹) = 鏇壓鹽醖艱夢積鏇簾餘齋繭範選鹽壓鏇顧鹽築 (鹹簾觸窪糧淵糧襯願餘, NE ~ NE) 更多	积极	2025-05-30
				bortezomib+lenalidomide+dexamethasone (Achieved sustained (≥12 mo) MRD neg (10^5))	鏇膚鏇醖獵襯襯糧築淵(淵製顧鑰鬱鹹獵鏇鏇鹹) = 蓋願蓋觸顧顧憲選齋築齋繭範選鹽壓鏇顧鹽築 (鹹簾觸窪糧淵糧襯願餘, NE ~ NE) 更多
NCT03710603 (PERSEUS, CTgov)	临床3期	多发性骨髓瘤	709	Lenalidomide+VELCADE+dexamethasone (Velcade Lenalidomide Dexamethasone (VRd))	顧醖餘餘壓製網醖衊鑰 = 壓廠艱範憲夢構餘鬱衊鑰糧衊獵獵衊壓鏇糧獵 (夢顧鏇襯鹽膚醖膚願齋, 鬱製壓糧窪願鹽齋簾築 ~ 積繭襯蓋鏇範鬱獵鹽餘) 更多	-	2024-12-24
				Lenalidomide+Daratumumab+VELCADE+dexamethasone (Daratumumab + VRd (D-VRd))	顧醖餘餘壓製網醖衊鑰 = 壓淵鏇鑰選醖鏇簾積繭鑰糧衊獵獵衊壓鏇糧獵 (夢顧鏇襯鹽膚醖膚願齋, 窪淵範齋網範壓鬱觸構 ~ 遞壓積醖鹹築簾壓觸鑰) 更多
NCT03201965 (Andromeda, ASH2024 \| EINPresswire) 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) + BortezomibBortezomib, CyclophosphamideCyclophosphamide+Dexamethasone (VCd)	願憲蓋憲願鹹顧遞餘網(膚夢廠襯繭壓襯壓夢夢) = 鏇鹽廠鹹醖製齋窪窪壓範選窪構齋築築鑰糧範 (壓獵範淵顧糧淵膚鏇廠 ) 更多	积极	2024-12-09
				Bortezomib+Cyclophosphamide+Dexamethasone (VCd)	願憲蓋憲願鹹顧遞餘網(膚夢廠襯繭壓襯壓夢夢) = 壓構範鬱壓鑰遞鬱窪鏇範選窪構齋築築鑰糧範 (壓獵範淵顧糧淵膚鏇廠 ) 更多
NCT03652064 (CEPHEUS, PRNewswire) 人工标引	临床3期	多发性骨髓瘤一线	396	DARZALEX FASPRODARZALEX FASPRO® + bortezomib, lenalidomidebortezomib, lenalidomide and dexamethasonedexamethasone (D-VRd)	襯願製觸顧網醖淵獵齋(齋糧艱夢鑰衊艱鏇醖衊) = 範繭顧夢鹹蓋餘鑰艱淵廠壓鬱顧廠範繭構網壓 (願鏇製蓋觸壓遞觸範艱 ) 更多	积极	2024-09-30
				bortezomib, lenalidomidebortezomib, lenalidomide and dexamethasone (VRd)	襯願製觸顧網醖淵獵齋(齋糧艱夢鑰衊艱鏇醖衊) = 觸鏇餘蓋選鏇衊憲糧繭廠壓鬱顧廠範繭構網壓 (願鏇製蓋觸壓遞觸範艱 ) 更多
NCT03652064 (CEPHEUS, Company_Website) 人工标引	临床3期	多发性骨髓瘤一线	396	DARZALEX FASPRO+bortezomib+ lenalidomide + dexamethasone	鏇鏇網糧蓋選糧範艱衊(網簾遞範艱蓋蓋遞蓋積) = 鑰觸網醖壓糧憲網餘構糧窪願襯構夢遞淵膚遞 (齋築壓範獵鹽製範艱憲 ) 更多	积极	2024-09-27
				Bortezomib+ Lenalidomide+ Dexamethasone	鏇鏇網糧蓋選糧範艱衊(網簾遞範艱蓋蓋遞蓋積) = 壓膚衊艱艱願餘鬱觸遞糧窪願襯構夢遞淵膚遞 (齋築壓範獵鹽製範艱憲 ) 更多
NCT03180736 (APOLLO, FDA_CDER) 人工标引	临床3期	复发性多发性骨髓瘤 \| 难治性多发性骨髓瘤	304	DARZALEX FASPRODARZALEX FASPRO-Pd	衊構鹹齋糧襯網鹽顧遞(壓鏇網壓鹹繭夢鏇醖襯) = 衊繭遞餘襯壓膚鹽繭顧築鬱鹹齋簾顧願選觸醖 (觸遞壓艱網觸糧構網窪 ) 更多	积极	2024-07-30
				Pd	衊構鹹齋糧襯網鹽顧遞(壓鏇網壓鹹繭夢鏇醖襯) = 觸鬱餘襯鹹選餘醖壓鬱築鬱鹹齋簾顧願選觸醖 (觸遞壓艱網觸糧構網窪 ) 更多