To learn if giving elranatamab before and after an autologous stem cell transplant (ASTC) can help to control newly diagnosed, high-risk MM. An ASTC is a type of transplant in which a person's own stem cells are collected, preserved, and returned to them.

开始日期2024-07-30

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT06287944 / Not yet recruiting临床1期IIT

Phase I Study of Escalating Doses of 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome

This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). 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. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, 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. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and/or effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS.

开始日期2024-06-18

申办/合作机构

City of Hope National Medical Center

[+1]

NCT05617625 / Suspended临床2期IIT

A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Myelodysplastic Syndrome

This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in fewer complications for patients who undergo transplant to treat a blood malignancy (cancer) or blood disorder.
The CliniMACS system will be used to remove immune T-cells from the transplant donor's blood. Immune T-cells contribute to graft versus host disease (GVHD) - a serious complication that can happen after transplant. GVHD occurs when a patient's immune system attacks the donor's cells. The study aims to reduce the number of the donor immune T-cells thereby preventing or reducing the severity of GVHD.

开始日期2024-06-01

申办/合作机构

Baptist Health South Florida, Inc.

100 项与美法仑相关的临床结果

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100 项与美法仑相关的转化医学

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100 项与美法仑相关的专利（医药）

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8,638

项与美法仑相关的文献（医药）

2024-03-01·European Journal of Haematology

Identification of clinical factors impacting outcome in patients undergoing autologous hematopoietic cell transplantation after BEAM and TEAM conditioning

Article

作者: Wäsch, Ralph ; Finke, Jürgen ; Duque-Afonso, Jesús ; Gherman, Radu-Florian ; Engelhardt, Monika ; Duyster, Justus ; Strüßmann, Tim ; Bertz, Hartmut ; Marks, Reinhard ; Stolz, Daiana ; Ewald, Sophie ; Ihorst, Gabriele ; Zeiser, Robert

Abstract:

Organ dysfunction, including pulmonary function impairment, plays a key role in the choice of conditioning chemotherapy before autologous hematopoietic stem cell transplantation (auto‐HSCT). Replacement of BCNU/carmustine as part of BEAM (BCNU/carmustine, etoposide, cytarabine, and melphalan) conditioning protocol by thiotepa (TEAM) reduces pulmonary toxicity while maintaining efficacy. We retrospectively analyzed the association of clinical characteristics, comorbidities, and organ function with outcomes after conditioning with BEAM or TEAM. Three hundred ninety‐six patients undergoing auto‐HSCT (n = 333 with BEAM; n = 63 with TEAM) at our institution between 2008 and 2021 were included in this study. In the multivariate analysis, CO‐diffusion capacity corrected for hemoglobin (DLCOcSB) ≤ 60% of predicted, progressive disease (PD) before auto‐HSCT, Karnofsky performance score (KPS) ≤ 80%, HCT‐CI score ≥ 4, and cardiac disease before auto‐HSCT were associated with decreased overall survival (OS) in patients treated with BEAM. In contrast, only PD before auto‐HSCT was identified in patients treated with TEAM. Patients conditioned with BEAM and DLCOcSB ≤ 60% had higher non‐relapse mortality, including pulmonary cause of death. In summary, we have identified clinical and pulmonary risk factors associated with worse outcomes in patients conditioned with BEAM compared to TEAM. Our data suggest TEAM conditioning as a valid alternative for patients with comorbidities, including pulmonary dysfunction and/or poorer performance scores, before auto‐HSCT.

2024-03-01·American Journal of Ophthalmology Case Reports

Pushing the limit: Globe salvage of Group D retinoblastoma with severe vitreous seeding with intra-arterial chemotherapy and 15 cycles of intravitreal chemotherapy

作者: Rabiee, Roxanna ; Greig, Eugenia C ; Afshar, Armin R

Purpose:

To report the successful treatment of persistent retinoblastoma vitreous seeding with 6 cycles of intra-arterial chemotherapy and 15 cycles of intravitreal chemotherapy injections.

Observations:

A three-year-old female presented to the ocular oncology clinic with Group D retinoblastoma with severe vitreous seeding. The patient received 3 cycles of intra-arterial chemotherapy (melphalan, topotecan, and carboplatin) and 15 cycles of intravitreal chemotherapy (melphalan and combined melphalan/topotecan). Complete tumor regression and resolution of vitreous seeding was achieved. The best corrected visual acuity in the affected eye was 20/50.

Conclusions and Importance:

Intravitreal chemotherapy for retinoblastoma vitreous seeding is often restricted to 8 treatment cycles. Patients who do not respond after 8 cycles face salvage therapy with radiation or enucleation. This is a case in which prolonged intravitreal chemotherapy delivery was well tolerated and resulted in sustained tumor remission, with useful visual acuity in the treated eye.

2024-02-01·The Journal of Clinical Pharmacology

Pharmacokinetics and Metabolism of Melflufen, an Alkylating Peptide–Drug Conjugate, in Patients with Relapsed Refractory Multiple Myeloma

Article

作者: Gullbo, Joachim ; Pekar, David ; Sjöberg, Per ; Huledal, Gunilla ; Kawakatsu, Sonoko ; Jerling, Markus ; Norin, Stefan ; Ruiz-Garcia, Ana ; Wang, Xiaoning

Abstract:

Melphalan flufenamide (melflufen) is a novel lipophilic peptide–drug conjugate recently approved in the European Union and the United Kingdom for the treatment of relapsed refractory multiple myeloma. Melflufen rapidly crosses the cell membrane, and inside tumor cells, melflufen utilizes peptidases and esterases to release entrapped hydrophilic metabolites with alkylating activity. In vitro, in whole blood, melflufen was rapidly distributed into blood cells and quickly converted to its main metabolite melphalan, with maximum cellular concentrations of noncovalently bound melflufen and melphalan after 1 and 6 minutes, respectively. Melphalan outflow from blood cells was slow, with peak concentrations in plasma after 25 minutes. The pharmacokinetics of melflufen was best described by a 2‐compartment model. Following a 30‐minutes intravenous infusion of 40 mg in 27 patients with relapsed refactory multiple myeloma, mean half‐life in the α phase of the curve was 1.24 minutes, half‐life in the β phase of the curve 26.7 minutes, and clearance 13.4 L/min. Desethyl‐melflufen exposure was below 20% compared to melflufen. Based on population analysis (298 patients with relapsed refactory multiple myeloma), the melphalan pharmacokinetics were well characterized by a 3‐compartment model with melflufen dosing into a peripheral compartment, assuming instantaneous distribution of melflufen into cells and subsequent rapid metabolism to melphalan. Mean clearance and central and deep peripheral volumes of distribution were 22.4 L/h, 2.70 L, and 51.3 L, respectively. Clearance increased and maximum concentration decreased with increasing body weight and estimated glomerular filtration rate. In conclusion, melflufen administration differs from melphalan administration by a more rapid distribution into cells, which, in conjunction with a rapid intracellular metabolism, allows for higher maximum concentrations of alkylating agents, and by a more extensive distribution of melphalan to peripheral tissues.

170

项与美法仑相关的新闻（医药）

2024-04-18

·美通社

陆道培医学团队携18项研究成果闪耀第50届欧洲血液与骨髓移植学会年会

北京 2024年4月18日 /美通社/ -- 2024年第50届欧洲血液与骨髓移植学会(EBMT)年会于2024年4月14-17日在英国格拉斯哥举行，作为久负盛名的国际造血干细胞移植领域盛会，本次EBMT年会规模宏大，汇聚全球近8000余名血液病领域专家学者，设置76个分会场，围绕近年来造血干细胞移植和细胞治疗领域前沿热点问题进行深度探讨。陆道培医疗团队EBMT会议现场合影本届会议陆道培医学团队代表携18项研究成果赴英现场参会，其中1项口头报告，内容涵盖了造血干细胞移植和细胞免疫治疗领域最前沿的进展及临床检验的相关研究，报告从数量和质量上都位于前列，展示出团队卓越的医疗技术水平以及蓬勃的创新能力，也是陆道培医学团队全球影响力的最佳印证。陆道培医院骨髓移植科胥方医生代表卢岳教授团队在EBMT上做口头发言当地时间，4月16日下午15：15，由陆道培医院骨髓移植科胥方医生代表卢岳主任团队在"Optimising donor Choice"环节中，口头汇报了"Comparing the Outcomes of Using Non-First-Degree Related Donors to First-Degree Related Donors in Haploidentical HSCT for Hematological Malignancies: A Case-Control Analysis"的临床研究成果，研究证实了在单倍体造血干细胞移植中，采用非直系供体在疗效及安全性方面均可以与直系供体相媲美，这也为临床上扩展单倍体移植供者的可选择范围提供了进一步的证据支持。卢岳主任团队这一项研究受到了颇多关注。胥方医生的口头报告逻辑清晰、条理分明，既展现了陆道培医学团队的专业素养，又体现了团队青年医师对学术研究的热情与追求。现场专家对卢岳主任团队的此项研究成果表现出极大的兴趣，表示此项研究为没有直系供者的患者带来了福音。值得一提的是，本环节的口头报告质量上乘，众多报告内容涵盖EBMT官方相关的多中心深入研究，能够荣幸入选这一环节口头报告，足以证明陆道培医学团队在移植领域的卓越表现，凸显了我们团队在学术研究上的广阔视野与深远影响力。除口头报告外，陆道培医学团队的17项墙报展示陆续亮相，其中12篇报告由团队青年医师作为第一作者。陆道培医学团队一贯重视青年骨干医生的培养，医院与科室团队不断优化人才培养环境，努力为青年医生的成长创造条件、搭建平台，鼓励他们"走出去"，通过参加国内国际进修培训，参与国际学术会议，不断深化对医学领域的理解，提升学术素养，打造一支素质优良、堪当重任的青年医师队伍。深思砺见，共筑未来。陆道培医学团队坚持走出去，紧跟国际前沿，聚焦当下血液病领域重难挑战，不断进行学术创新，扩展临床实践，优化诊疗策略，突破传统治疗"天花板"，力求最大程度改善治疗效果，为广大血液病患者带来更多希望和温暖。 EBMT 2024 成果一览口头报告 (ORAL) 摘要号：959 第一作者：卢岳，通讯作者：卢岳题目：Comparing the Outcomes of Using Non-First-Degree Related Donors to First-Degree Related Donors in Haploidentical HSCT for Hematological Malignancies: A Case-Control Analysis 墙报展示（ POSTER）摘要号：257 第一作者：朱会丽，通讯作者：魏志杰题目：Efficacy and Safety Analysis of Prophylactic Basiliximab Vedotin Administration after Pediatric Acute Leukemia Haploidentical Hematopoietic Stem Cell Transplantation 摘要号：284 第一作者：何海，通讯作者：孙瑞娟题目：Intensive Conditioning Regimen for Allogeneic Hematopoietic Stem Cell can Overcome the Poor Prognosis of T(6;9)/DEK-NUP214 AML 摘要号：391 第一作者：颜述，通讯作者：刘德琰题目：The Clinical Analysis of Allogeneic Hematopoietic Stem Cell Transplantation in Therapy-Related Myeloid Neoplasms 摘要号：733 第一作者：潘飞，通讯作者：魏志杰题目：Clinical Outcomes of Allogeneic Hematopoietic Stem Cell Transplantation Using Busulfan/Cyclophosphamide and Melphalan or Thiotepa as Conditioning Regimen in 37 Patients with Acute Megakaryoblastic Leukemia 摘要号：835 第一作者：赵艳丽，通讯作者：赵艳丽题目：Allogeneic Transplantation Using Myeloablative Conditioning Regimes is Safe and Effective in Elderly Patients Over 60 Years with AML and MDS 摘要号：967 第一作者：同格乐通讯作者：卢岳题目： TLS∷ERG Fusion Gene Predicts A Poor Prognosis after Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia: A Single Center Study 摘要号：998 第一作者：魏志杰，通讯作者：魏志杰题目：Haploidentical Hematopoietic Cell Transplantation with Unrelated Cord Blood Enhances Survival and Reduces the Incidence of aGVHD for Pediatric Acute Myeloid Leukemia 摘要号：1070 第一作者：董磊，通讯作者：曹星玉题目：Analysis of the Efficacy of Luspatercept in the Treatment of Anemia after Allogeneic Haematopoietic Stem Cell Transplantation 摘要号：1074 第一作者：马薇，通讯作者：曹星玉题目：Rituximab for the Treatment of Steroid-Refractory Oral Chronic Graft-Versus-Host Disease after Allo-Hematopoietic Stem Cell Transplantation 摘要号：1102 第一作者：潘飞，通讯作者：魏志杰题目：Efficacy Analysis of Haploidentical Transplantation Using Busulfan/Cyclophosphamide and Melphalan as Conditioning Regimen for Relapsed and Refractory Acute Myeloid Leukemia 摘要号：1103 第一作者：胥方，通讯作者：卢岳题目：Diagnosis of Mucormycosis in Allogeneic Hematopoietic Stem Cell Transplantation Using Metagenomic Next-Generation Sequencing: A Single-Center Clinical Study 摘要号：1306 第一作者：李楠楠，通讯作者：张建平题目：Allogeneic Hematopoietic Stem Cell Transplantation with Bu(2)/Cy/Flu/ATG can Achieve Good Results in Treatment of Transfusion Dependent Non-Severe Aplastic Anemia 摘要号：1338 第一作者：孙瑞娟，通讯作者：孙瑞娟题目：Comparisons of Safety and Efficacy of Allo-HSCT after CAR T-Cell or Chemotherapy-Based Complete Remission in Pediatric T-ALL 摘要号：1730 第一作者：王东出，通讯作者：王卉题目：Relevant Studies on Cytokines Level and CAR-T Expansion Associated to CD7 CAR-T Therapy 摘要号：1743 第一作者：张建平，通讯作者：张建平题目：ATLG has Better Safety than RATG in the Treatment of Adult AA with Allogeneic Hematopoietic Stem Cell Transplantation 摘要号：1748 第一作者：陈曼，通讯作者：王卉题目：Stratification and Immunologic Analysis of Patients with SARS-CoV-2 Infection after Hematopoietic Stem Cell Transplantation 摘要号：1755 第一作者：张建平，通讯作者：张建平题目：Study on The Efficacy and Safety of Blinatumomab Maintenance Therapy of High Risk Ph Negative ALL after Allo-HSCT 注：上述研究成果按摘要号排序

细胞疗法

2024-04-11

·研发客

Genmab营收主力Darzalex，能否成为百亿美元分子？| 光影

// 全球畅销药品TOP10榜单风起云涌，那些跻身“百亿美元分子”行列的分子能否续写传奇？研发客将梳理出一些刚迈入或即将迈入这一行列的产品，通过它们各具特色的成长进阶之路，寻找可以回答上述疑问的蛛丝马迹。本期我们先解读强生用于治疗多发性骨髓瘤的抗CD38单抗Darzalex。近期全现金收购普方生物的丹麦生物技术公司Genmab，正是Darzalex的缔造者，后将该药授权给了强生。根据财报计算，Darzalex的2023年营收，占Genmab总营收超过了68%。强生首席执行官兼董事长Joaquin Duato对未来充满期待：“到2030年，我们将在多发性骨髓瘤领域取得250多亿美元的销售额，50%以上的患者将接受强生推出的方案进行治疗。”Darzalex虽然2023年销售额未及百亿，但2024年或许能冲关成功。强生2023年财报显示，其多发性骨髓瘤（MM）新药抗CD38单抗Darzalex（daratumumab，达雷妥尤单抗）全年收入达到97.44亿美元。根据Evaluate发布的2024年全球畅销药TOP10榜单，该药预计将在今年取得近120亿美元的营收。不过Darzalex同样面临着专利悬崖和激烈竞争。根据美国证监会（SEC）披露的信息，Darzalex在美国、欧洲和日本的组合物专利将于2026年3月到期。在此之前，已有生物类似药蠢蠢欲动，比如复宏汉霖的HLX15早在2021年就在中国获批临床。当下，CD38靶向疗法研发正当时，来自赛诺菲的全球第二款抗CD38单抗Sarclisa已获批，另有多款靶向CD38的单抗、双抗、CAR-T、ADC等创新疗法正在开发中。针对MM的治疗手段更是推陈出新，HDAC抑制剂Farydak、靶向作用于SLAMF7的Empliciti、口服XPO1抑制剂塞利尼索、BCMA双抗Blenrep、BCMA CAR-T疗法Abecma等均已相继获批。面对激烈的竞争，Darzalex能否脱颖而出呢？扩张一线治疗MM的份额根据强生公布的2023年业务回顾，Darzalex被该公司视为多发性骨髓瘤前线治疗和整个治疗过程的中坚力量。目前，该产品还在开展多项3期试验，拟拓展适应症，包括一线治疗符合及不符合自体干细胞移植的新诊断MM、Smoldering Multiple Myeloma（郁积多发性骨髓瘤或冒烟型多发性骨髓瘤）等。其中，治疗适合移植的新确诊MM患者的PERSEUS试验已在2023年12月取得积极结果，受试者接受Darzalex方案治疗可将疾病进展或死亡风险降低58%，4年无进展生存率达84.3%。强生预计基于该结果的补充适应症申请将于今年在美国获得批准。此外，强生还在探索该药与其它新分子联合治疗的潜力，包括BCMA/CD3双抗Tecwayli、GPRC5D/CD3双抗Talvey以及BCMA CAR-T疗法Carvykti，以期实现从MM末线治疗到一线治疗的全面覆盖。比如，分别与这两款双抗联合用于2～3线治疗的MajesTEC-3试验和MonumenTAL-3试验正在入组，联合Tecwayli用于不符合移植新诊断患者的3期MajesTEC-7试验将在今年启动，联合Carvykti用于符合移植新诊断患者的CARTITUDE-6试验也正在开展中。来源｜强生2023年业务回顾PPT强生首席执行官兼董事长Joaquin Duato曾在今年1月JPM大会上表示，Darzalex正在不断扩张MM一线治疗的市场份额，未来继续增长的潜力依然巨大。同时，另外3款产品的销售峰值均有望超过50亿美元。随着这4款新药推向一线治疗，它们将改变MM患者结局的定义方式，推动疾病从治疗走向治愈。“到2030年，我们将在多发性骨髓瘤领域取得250多亿美元的销售额，50%以上的患者将接受强生推出的方案进行治疗。”Duato对未来充满期待。拓展阅读谁是下一代药王？在2023年业务回顾中，强生还立下了“治愈超过50%的MM患者”的宏愿。跨越一个多世纪的故事Darzalex能够跻身“百亿美元分子”行列，离不开过去一个多世纪科学研究的积累。时钟拨回1844年4月15日，39岁的Sarah Newbury来到伦敦圣托马斯医院。住院前，她的丈夫只是将其抱上床，就导致其股骨、锁骨、右肱骨、右桡骨、尺骨等相继骨折。尽管及时接受治疗，Newbury还是在5天后匆匆离世。这也是首个有充分记录的MM病例。全身多处骨折的Sarah Newbury来源｜Recent Results Cancer Res 杂志同年9月，另一位名叫McBean的伦敦商人在度假时也出现了类似的突发症状。他仅仅是从一个地下洞穴中跳出来，就“感觉胸口好像有什么东西断裂了”，剧烈的疼痛令他无法动弹。此后不到一年半他就去世，尸检发现其骨头柔软、易碎、易骨折。在这之后，与McBean类似的病例开始获得医学界关注。不过“多发性骨髓瘤”一词的首次引入，已是近30年之后。1873年，俄罗斯病理学家Rustizky在尸检中发现，一名47岁的患者体内同时存在八种不同的骨髓瘤，并将其定名为多发性骨髓瘤。此后关于MM的研究越来越多，并证实了这是一种由浆细胞异常增生造成的恶性肿瘤，其特征为单克隆浆细胞恶性增殖并分泌大量单克隆免疫球蛋白，常伴有多发性溶骨性损害、高钙血症、贫血和肾脏损害等。早期针对MM的治疗方法包括大黄、水蛭、奎宁、氨基甲酸乙酯等，不过大多对疾病无效。后来临床上又相继引入美法仑、泼尼松、外周血干细胞移植、硼替佐米、来那度胺等疗法，虽然在疗效上有所突破，但几乎所有患者都会复发或耐药，部分产品还有骨髓抑制、血栓形成等风险。在这种背景下，Darzalex作为第一种可用于复发或难治性MM患者的抗CD38单克隆抗体，以全新的作用方式为末线患者带来希望。首款抗CD38单抗诞生故事要追溯到1980年。这一年，哈佛医学院的Reinherz、Schlossman及其同事在研究人淋巴细胞表面抗体时，首次发现了CD38。此后人们又发现，CD38在多发性骨髓瘤患者浆细胞中呈现出高特异性和高表达的特征，这使它成为治疗该疾病的理想靶点。20世纪90年代，已有学者合成了针对MM细胞的抗CD38抗体。21世纪初，产业界也开始关注抗CD38抗体的研发。其中就包括Genmab，并且一钻研就是近10年。拓展阅读Genmab：力争开发出“震掉你袜子”的癌症抗体药物2012年，Genmab将抗CD38抗体daratumumab推进至1/2期临床阶段。同年8月，强生以5500万美元预付款拿下了该产品全球独家权利。同一时期，由赛诺菲研发的同靶点产品isatuximab也已进入早期临床。研究显示，靶向CD38的抗体可直接与骨髓瘤细胞表面CD38特异性结合，通过Fc依赖的免疫效应机制、免疫调控作用和直接交联反应等多重机制诱导骨髓瘤细胞死亡，从而实现疾病快速缓解。来源｜《中国临床药学杂志》因疗效突出，daratumumab曾先后获得FDA授予治疗MM的快速通道资格、突破性疗法认定、孤儿药资格和优先审评资格，并最终于2015年11月在美国获得加速批准，单药用于MM四线治疗，商品名为Darzalex。对于Darzalex的获批，多发性骨髓瘤研究基金会（MMRF）总裁兼首席执行官Walter Capone曾给予高度肯定：“我们正在迎来骨髓瘤治疗的新时代。”在关键性2期研究MMY2002中，那些接受过包括蛋白酶体抑制剂、免疫调节剂在内5种疗法的患者，给予单剂Darzalex治疗后仍然能够取得29.2%的总有效率（ORR）。“Darzalex作为一种不良事件可接受的单一药物显示出显著的疗效。这对于这些过度预治疗的患者尤其重要，因为目前所有主要药物都失败了。”在首次获批的新闻稿中，该产品临床项目负责人Paul Richardson也曾表示。一路高歌首次获批后，Darzalex就进入审批快车道，几乎每年都有新适应症获得FDA批准，包括全面进军MM前线治疗，与来那度胺、地塞米松、硼替佐米等传统疗法联合使用，拓展应用至原发性轻链型淀粉样变等。同时，强生也不忘向欧洲、加拿大、中国等全球其它重要市场进军，其中在中国上市时间为2019年10月。拓展阅读亿珂快速上市背后由于该药静脉注射耗时长，患者顺应性不佳，强生还与Halozyme公司合作开发了皮下制剂，并于2020年在美国获批。新剂型中的重组人透明质酸酶PH20可以促进药物渗透和吸收，从而将给药时间从几小时缩短至大约3～5分钟。拓展阅读Halozyme：皮下药物递送的顶尖高手多措并举使得Darzalex上市以来一直保持高速增长（见Darzalex历年销售额图），不仅接替了强生产品线中专利到期后失势的硼替佐米，更是一跃成为该公司销量第二的药品。到2023年，该药全球销售额已逼近100亿美元。考虑到多发性骨髓瘤是一种罕见癌症，全球发病率约为1.78/10万人，市场空间有限却从不缺竞争对手，比如连续三年销售额超百亿美元的来那度胺，来势汹汹的CAR-T、ADC等新分子疗法，未来Darzalex能否持续辉煌，我们拭目以待。编辑 | 戴佳凌dai.jialing@PharmaDJ.com 总第2086期访问研发客网站可浏览更多文章www.PharmaDJ.com

免疫疗法抗体药物偶联物财报细胞疗法生物类似药

2024-04-04

·BioSpace

Delcath Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) - April 04, 2024

NEW YORK, April 4, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announces that the Company granted an equity award, previously approved by the Company's Compensation Committee, as a material inducement to the employment of one individual whose employment commenced in March 2024. The grant totaled the right to purchase an aggregate of 30,000 shares of the Company's common stock and is subject to the terms and conditions of the Company's 2023 Inducement Plan ("Plan"). The options were granted on March 29, 2024, the date the Compensation Committee approved the stock option included within the equity inducement and are subject to an exercise price equal to $4.77, the closing price of Delcath's common stock on March 28, 2024 (as the Nasdaq market was closed on the grant date). One-third of the options will vest on the first anniversary of the grant date with the remaining two-thirds of the options vesting in equal monthly installments over the following twenty-four months. The option has a ten-year term and the vesting of the options is subject to the employee's continued employment with Delcath on each vesting date. The above-described awards were each granted in accordance with NASDAQ Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. About Delcath Systems, Inc. Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company's proprietary products, HEPZATO KIT™ (melphalan for Injection/Hepatic Delivery System), approved for use in the United States by the Food and Drug Administration, and CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), designated under the medical device regulation for use in Europe and the United Kingdom, are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. For more information regarding HEPZATO KIT and its use, including Important Safety Information and Boxed Warning, please visit HEPZATOKIT.com. For more information regarding CHEMOSAT and its use, please visit Chemosat.com. Contact: Investor Relations Contact: Ben Shamsian Lytham Partners 646-829-9701 shamsian@lythampartners.com View original content to download multimedia: SOURCE Delcath Systems, Inc. Company Codes: NASDAQ-NMS:DCTH

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100 项与美法仑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00369	美法仑	L01AA03	DB01042

研发状态

适应症	最高研发状态	国家/地区	公司
卵巢癌	批准上市	加拿大更多	Apotex, Inc. 更多
多发性骨髓瘤	批准上市	日本更多	Sandoz KK 更多
乳腺癌	批准上市	中国更多	Glaxo Wellcome, Inc. 更多
复发性髓母细胞瘤	无进展	加拿大更多	National Cancer Institute 更多
骨髓肿瘤	无进展	美国更多	The University of Texas MD Anderson Cancer Center 更多

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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


NCT02700841 (CTgov)	临床2期	多发性骨髓瘤	8	Peripheral Blood Stem Cell Transplantation--CD34 HSCT+Melphalan (Arm I (Vaccine, CD34 Transplant, DLI))	鏇鬱鬱憲壓構製蓋遞糧(襯繭窪獵艱艱積糧壓築) = 獵齋糧鬱網鏇鑰範鏇鬱蓋繭繭襯構繭醖遞積簾 (膚簾淵壓觸鏇積醖鹹築, 構廠糧淵網襯鬱鏇衊鏇 ~ 簾鏇壓艱廠遞簾鏇鑰鹹) 更多	-	2024-03-12
				Tetanus Toxoid Vaccine+Melphalan (Arm II (Vaccine, Stem Cell Transplant))	鏇鬱鬱憲壓構製蓋遞糧(襯繭窪獵艱艱積糧壓築) = 獵衊遞鹽顧廠範鹽範網蓋繭繭襯構繭醖遞積簾 (膚簾淵壓觸鏇積醖鹹築, 繭艱獵遞鑰積衊膚構蓋 ~ 鬱糧廠鬱獵鏇築壓鹹餘) 更多
NCT02251821 (CTgov)	临床2期	原发性骨髓纤维化	61	Umbilical Cord Blood Transplantation+Fludarabine Phosphate+Busulfan+CYCLOPHOSPHAMIDE+Melphalan+Tacrolimus+Ruxolitinib+mycophenolate mofetil+Methotrexate	觸膚夢遞選壓築憲壓衊(範顧衊鏇構艱鬱觸壓憲) = 夢築築鹹蓋餘構膚鏇糧壓積醖壓築築構構夢積 (鑰繭築餘艱築觸鹹憲膚, 鹹憲夢齋鑰範窪範鑰簾 ~ 選築網鹹簾選選獵築鑰) 更多	-	2024-03-05
ASH2023	N/A	多发性骨髓瘤	-	Melphalan 200mg/m2	襯憲糧選鹽廠蓋鏇鏇齋(鏇膚淵構衊糧艱膚製餘) = 鬱積鏇願衊網網積繭鬱夢鑰遞鏇鹹製齋艱網齋 (鏇繭窪選構淵廠鹽顧壓 ) 更多	-	2023-12-11
				Melphalan 140mg/m2	襯憲糧選鹽廠蓋鏇鏇齋(鏇膚淵構衊糧艱膚製餘) = 蓋願簾鏇遞壓積製製顧夢鑰遞鏇鹹製齋艱網齋 (鏇繭窪選構淵廠鹽顧壓 ) 更多
ASH2023	N/A	急性髓性白血病	186	High-dose melphalan followed by fractionated total body irradiation (TBI)	憲顧廠鏇艱鬱製憲窪觸(廠願鑰衊醖壓範鬱餘襯) = 構鬱構積網窪蓋糧網憲構鹽蓋觸襯淵壓鹽鬱獵 (範醖膚繭簾醖糧簾齋鹽, 49 ~ 70.8)	-	2023-12-11
				High-dose melphalan followed by non-TBI regimens (busulfan or treosulfan)	憲顧廠鏇艱鬱製憲窪觸(廠願鑰衊醖壓範鬱餘襯) = 鏇夢鹹選鏇淵獵齋糧齋構鹽蓋觸襯淵壓鹽鬱獵 (範醖膚繭簾醖糧簾齋鹽, 36.7 ~ 58.1)
ASH2023	N/A	免疫球蛋白轻链淀粉样变性	1,718	Full dose melphalan	膚願獵淵顧鹹糧積願夢(餘襯鏇顧遞願襯製顧積) = 壓範顧觸夢膚網鹽窪夢鏇窪範鏇遞鑰積顧襯齋 (鹹製醖繭淵觸鏇繭艱觸 )	-	2023-12-11
				One day of melphalan conditioning	膚願獵淵顧鹹糧積願夢(餘襯鏇顧遞願襯製顧積) = 顧窪選觸窪獵範醖廠築鏇窪範鏇遞鑰積顧襯齋 (鹹製醖繭淵觸鏇繭艱觸 )
ASH2023	N/A	急性髓性白血病 \| 急性淋巴细胞白血病	198	Cyclophosphamide and Total-Body Irradiation (Cy/TBI)	襯網網醖網糧鏇衊網製(醖壓鹽鏇構鬱醖襯襯鏇) = 鏇構鏇顧遞鑰鬱齋憲鏇鹽鹽壓遞蓋範膚範網鏇 (餘糧鬱艱艱鹽鑰製鬱齋 ) 更多	-	2023-12-11
				Fludarabine, Melphalan, and Total-Body Irradiation (Flu/Mel/TBI)	襯網網醖網糧鏇衊網製(醖壓鹽鏇構鬱醖襯襯鏇) = 齋獵淵蓋鏇顧壓願窪獵鹽鹽壓遞蓋範膚範網鏇 (餘糧鬱艱艱鹽鑰製鬱齋 ) 更多
ASH2023	N/A	急性髓性白血病	-	Fludarabine/melphalan with Tacrolimus/Sirolimus	醖範壓鹹夢鹽襯鏇構淵(壓淵蓋獵獵遞鑰艱夢範) = 夢糧齋鬱蓋網蓋壓獵鏇淵鏇顧餘願遞廠餘範蓋 (襯鹽鹽築蓋淵鑰顧構鬱, 0.19 ~ 0.28) 更多	-	2023-12-11
ALCYONE (ASH2023)	N/A	多发性骨髓瘤一线	111	Daratumumab, Bortezomib, Melphalan, and Prednisone (D-VMP)	觸糧鬱窪蓋網壓醖蓋夢(淵鹹憲繭醖網膚鑰膚鏇) = 淵遞鹹糧齋憲鬱夢鏇積鹹膚夢鹹襯願夢鑰夢鏇 (廠繭積憲膚齋艱築獵醖 ) 更多	-	2023-12-11
Octans and Alcyone (ASH2023)	临床3期	多发性骨髓瘤	-	Bortezomib, Melphalan, and Prednisone	醖膚築壓繭膚願積艱淵(糧顧簾願淵壓簾膚鹹襯) = 襯獵觸廠蓋衊衊廠構觸襯製餘蓋夢鏇窪齋蓋淵 (網範鏇簾鏇觸繭製鹽觸 ) 更多	-	2023-12-09
				Daratumumab + Bortezomib, Melphalan, and Prednisone	醖膚築壓繭膚願積艱淵(糧顧簾願淵壓簾膚鹹襯) = 鬱簾艱窪積醖顧淵範膚襯製餘蓋夢鏇窪齋蓋淵 (網範鏇簾鏇觸繭製鹽觸 ) 更多
AASLD2023	N/A	肝癌	31	MELPHALAN	蓋顧壓構網廠襯淵觸範(鬱鏇範糧憲顧淵構淵鹹) = 顧鹹淵簾齋窪醖壓網淵窪範餘鬱鹹窪範築鏇鹹 (築遞鏇窪淵構鏇鬱顧選 ) 更多	-	2023-11-10