来那度胺(Lenalidomide) - 药物靶点：CK1α x CRBN x IFNγ x IKZF1 x IKZF3 x IL-2 x IL-6 x TNF-α_在研适应症：边缘区B细胞淋巴瘤，成人T细胞白血病/淋巴瘤，染色体5q缺失综合征_专利_临床

概要

基本信息

药物类型

小分子化药、分子胶

别名

1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline、3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione、CMIO-LLD

+ [17]

靶点

CK1α x CRBN x IFNγ x IKZF1 x IKZF3 x IL-2 x IL-6 x TNF-α

作用机制

CK1α抑制剂(casein kinase 1 alpha 1 inhibitors)、CRBN调节剂(Cereblon蛋白调节剂)、IFNγ刺激剂(干扰素-γ刺激剂)

治疗领域

肿瘤免疫系统疾病心血管疾病+ [7]

在研适应症

边缘区B细胞淋巴瘤成人T细胞白血病/淋巴瘤染色体5q缺失综合征+ [63]

非在研适应症

Aase Smith综合征II型急性白血病急性淋巴细胞白血病+ [96]

原研机构

Celgene Corp.

在研机构

Bristol-Myers Squibb Pharma EEIG

Amgen, Inc.

Celgene Corp.

+ [29]

非在研机构

Cephalon, Inc.Janssen-Cilag International NVRoche Pharma AG

+ [6]

最高研发阶段批准上市

首次获批日期

美国 (2005-12-27),

骨髓增生异常综合征

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、优先审评 (中国)、孤儿药 (日本)、特殊审批 (中国)

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结构

分子式C13H13N3O3

InChIKeyGOTYRUGSSMKFNF-UHFFFAOYSA-N

CAS号191732-72-6

关联

1,320

项与来那度胺相关的临床试验

NCT06649812 / Not yet recruiting临床2期IIT

A Phase 2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

开始日期2025-01-17

申办/合作机构

National Cancer Institute

NCT06665217 / Not yet recruiting临床2期IIT

Glofitamab, Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma

The goal of this phase 2 trial is to test the safety and efficacy of G-Pola-ZLP as induction therapy in patients with DLBCL.

开始日期2025-01-01

申办/合作机构

海军总医院

NCT06441097 / Not yet recruiting临床2期IIT

A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination With POLA-RCHP VERSUS POLA-RCHP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

开始日期2024-12-31

申办/合作机构

上海交通大学医学院附属瑞金医院

100 项与来那度胺相关的临床结果

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100 项与来那度胺相关的转化医学

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100 项与来那度胺相关的专利（医药）

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6,013

项与来那度胺相关的文献（医药）

2024-12-31·Hematology (Amsterdam, Netherlands)

Combination therapy with venetoclax and azacitidine for the treatment of myelodysplastic syndromes with DDX41 mutations

Article

作者: Wang, Xin ; Qu, Shiqiang ; Gale, Robert Peter ; Qin, Tiejun ; Pan, Lijuan ; Xiao, Zhijian ; Jia, Yujiao ; Li, Bing ; Jiao, Meng ; Gao, Qingyan ; Xu, Zefeng

Myelodysplastic syndromes (MDS) patients with DEAD-box helicase 41 (DDX41) mutations have been reported to be treated effectively with lenalidomide; however, there are no randomized studies to prove it. Venetoclax and azacitidine are safe and effective in high-risk MDS/AML. In this study, we evaluated the efficacy of venetoclax and azacitidine combination therapy in eight consecutive MDS patients with DDX41 mutations at our centre from March 2021 to November 2023. We retrospectively analyzed the genetic features and clinical characteristics of these patients. Our findings suggest that MDS patients with DDX41 mutation may benefit from the therapy, for six subjects received this regimen as initial therapy and five of the six subjects achieved complete remission.

2024-12-31·Human vaccines & immunotherapeutics

Tafasitamab for the treatment of patients with diffuse large B-cell lymphoma

Article

作者: Stathis, Anastasios ; Zucca, Emanuele ; Pirosa, Maria Cristina

Patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) require additional treatments, especially those not eligible or not responding to high dose cytotoxic chemotherapy and stem cell transplantation. Over the last few years, several new treatments have been developed and approved for these patients, among them of particular relevance are those targeting CD19. Tafasitamab is a humanized monoclonal antibody targeting CD19, composed of a modified fragment crystallizable (Fc) region engineered with higher affinity for Fc gamma receptors (FcγR) receptors, leading to increased cytotoxicity through natural killer cells and macrophages (antibody-dependent cellular cytotoxicity and antibody-dependent cell-mediated phagocytosis). In this product review, we will discuss its mechanism of action, safety profile and efficacy results from clinical trials that led to its approval in combination with lenalidomide for patients with R/R DLBCL ineligible for high-dose chemotherapy and autologous transplantation.

2024-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of mosunetuzumab for treatment of relapsed or refractory follicular lymphoma after two or more lines of systemic therapy in the United States

Article

作者: Sanchez Alvarez, Javier ; Lin, Shih-Wen ; Parisé, Hélène ; Di Maio, Danilo ; Zuk, Eric ; Kim, Eunice ; Shapouri, Sheila ; Matasar, Matthew

AIMS:

Mosunetuzumab has received accelerated approval by the US Food and Drug Administration for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. We evaluated the cost-effectiveness of mosunetuzumab for the treatment of R/R FL from a US private payer perspective.

MATERIALS AND METHODS:

A partitioned survival model simulated lifetime costs and outcomes of mosunetuzumab against seven comparators: axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), tazemetostat (taz, EZH2 wild-type only), rituximab plus lenalidomide (R-Len) or bendamustine (R-Benda), obinutuzumab plus bendamustine (O-Benda), and a retrospective real-world cohort (RW) based on current patterns of care derived from US electronic health records (Flatiron Health). Efficacy data for mosunetuzumab were from the pivotal Phase II GO29781 trial (NCT02500407). Relative treatment efficacy was estimated from indirect treatment comparisons (ITCs). Costs included were related to treatment, adverse events, routine care, and terminal care. Except for drug costs (March 2023), all costs were inflated to 2022 US dollars. Costs and quality-adjusted life-years (QALYs) were used to calculate incremental cost-effectiveness ratios (ICERs). Net monetary benefit (NMB) was calculated using a willingness-to-pay (WTP) threshold of $150,000/QALY.

RESULTS:

Mosunetuzumab dominated taz, tisa-cel, and axi-cel with greater QALYs and lower costs. Mosunetuzumab was projected to be cost-effective against R-Benda, O-Benda, and RW with ICERs of $78,607, $42,731, and $21,434, respectively. Mosunetuzumab incurred lower costs but lower QALYs vs. R-Len. NMBs showed that mosunetuzumab was cost-effective against comparators except R-Len.

LIMITATIONS:

Without head-to-head comparative data, the model had to rely on ITCs, some of which were affected by residual bias. Model inputs were obtained from multiple sources. Extensive sensitivity analyses assessed the importance of these uncertainties.

CONCLUSION:

Mosunetuzumab is estimated to be cost-effective compared with approved regimens except R-Len for the treatment of adults with R/R FL.

1,431

项与来那度胺相关的新闻（医药）

2024-11-13

·Business Wire

Enterome to Host Webinar on New Clinical Data From the Ongoing Phase 1/2 ‘SIDNEY’ Trial of Lead Programme, EO2463

PARIS--( BUSINESS WIRE )-- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for cancer based on its unique Mimicry platform , will be holding a webinar to run through new clinical data from the ongoing Phase 1/2 ‘SIDNEY’ trial of EO2463, for the treatment of patients with either newly diagnosed, previously untreated follicular lymphoma (FL) [EO2463 monotherapy], or FL and marginal zone lymphoma relapsed/refractory disease [EO2463 in combination with lenalidomide/rituximab]. The data is being presented in two posters at the 66 th American Society of Hematology (ASH) Annual Meeting and Conference by Jose Caetano (JC) Villasboas Bisneto, MD, PhD, principal study investigator at the Mayo Clinic, and Stephen Smith, MD, hematologist and medical oncologist at the Fred Hutchinson Cancer Center. Poster details Abstract #1616 - EO2463 Peptide Immunotherapy in Patients with Indolent NHL: A Phase 1 Exploration of a Response Biomarker for EO2463 Monotherapy and EO2463 in Combination with Lenalidomide/Rituximab Abstract #4395 - EO2463 Peptide Immunotherapy in Patients with Newly Diagnosed Asymptomatic Follicular Lymphoma Results in Monotherapy Objective Clinical Responses Linked with Anti-Peptide Specific CD8 Memory T Cell Responses: The EONHL1-20/SIDNEY Study Webinar details are as follows: Date : 12 December 2024 Time : 9.30am-10.35am PT / 12.30pm-1.35pm ET / 5.30pm-6.35pm UK / 6.30pm-7.35pm CET Presenters : Pierre Belichard PhD, CEO, Enterome Laurent Chene PhD, Head of Drug Discovery, Enterome Jose Caetano (JC) Villasboas Bisneto, MD, PhD, Mayo Clinic Jan Fagerberg, MD, PhD, CMO of Enterome will also be present for the Q&A session following the presentation. To attend, please register your details at enterome@vigoconsulting.com . Questions can be submitted at any time during the presentation. Background About EONHL1-20/SIDNEY: SIDNEY (EONHL1-20) is a Phase 1/2 multicenter, open-label, first-in-human study of EO2463 as a monotherapy and in combination with lenalidomide and/or rituximab for the treatment of patients with iNHL. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in approximately 60 patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL). For more information on the study, visit www.Clinicaltrials.gov , reference: NCT04669171 . About EO2463: EO2463 is an innovative, off-the-shelf immunotherapy candidate that combines four synthetic OncoMimic™ peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). EO2463 also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2). The unique ability of EO2463 immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes that are abundant in iNHL. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms. About Enterome Enterome is a clinical-stage biopharmaceutical company developing breakthrough immunomodulatory drugs for the treatment of cancer. Enterome’s pioneering approach to drug discovery is based on its unique and powerful bacterial Mimicry drug discovery platform, which allows it to analyze and uncover new biological insights from the millions of gut bacterial proteins in constant cross-talk with the human body. Enterome’s first-in-class drug candidates are based on synthetically produced, commensal-derived peptides that modulate the immune system by closely mimicking the structure of specific antigens. The company’s oncology pipeline includes the following OncoMimics™ peptide-based immunotherapies: EO2463, currently in the Phase 2 ‘SIDNEY’ clinical trial for indolent non-Hodgkin lymphomas, has shown a favorable safety profile with promising early signs of efficacy; EO2401, administered in combination with nivolumab and bevacizumab, has demonstrated clinical activity in approximately one-third of patients with recurring glioblastoma in the completed Phase 1/2 ‘ROSALIE’ study; EO4010 is being evaluated in metastatic colorectal cancer in the Phase 1/2 ‘AUDREY’ study. Enterome is headquartered in Paris, France. Since its inception, the company has raised a total of €118 million from Europe- and US-based life science investors, and more than €100 million through pharmaceutical partnerships. For more information, visit: www.enterome.com

免疫疗法临床2期临床结果ASH会议临床1期

2024-11-13

·Firstwordpharma

Sanofi's fight for myeloma drug Sarclisa wins reprieve from NICE

The UK's National Institute for Health and Care Excellence (NICE) has agreed to re-assess Sanofi's Sarclisa (isatuximab) combination therapy for relapsed and refractory multiple myeloma, after previously rejecting the treatment in its final draft guidance.Sanofi is looking to get a NICE recommendation for using the anti-CD38 therapy in a subgroup of the population within its existing marketing authorisation – specifically in fourth-line adult patients who have had Revlimid (lenalidomide) and a proteasome inhibitor, and whose disease progressed on their last treatment.In June, the agency issued final draft guidance not recommending for this group. At the time, Sanofi said Sarclisa plus pomalidomide and dexamethasone (Isa-Pd) has become widely used in England and Wales through the Cancer Drugs Fund, with over 1700 patients receiving it. However, the company believed that under NICE's current rules, Isa-Pd would not be considered cost-effective, even if the price of Sarclisa was "offered at zero price," arguing that the existing system doesn't fairly evaluate combination medicines like Isa-Pd.Sanofi along with Myeloma UK and the UK Myeloma Society successfully appealed that decision, which now opens the door to a third NICE committee meeting. Specifically, the appeal panel upheld four of Sanofi's grounds, including that NICE's evaluation methods have evolved since the combination first entered the Cancer Drugs Fund."We are encouraged by NICE's decision to uphold our appeal, which will be welcomed by clinicians, patient groups and patients for whom the potential loss of a multiple myeloma treatment will be devastating," said Anju Bhalla, head of oncology and haematology at Sanofi UK and Ireland. "This appraisal has been protracted and complex for several reasons, but we remain hopeful of a positive outcome at the third time of sitting around the table together."The efficacy of Isa-Pd was evaluated in the Phase III ICARIA-MM trial. Patients treated with the combo lived without disease progression for an average of 12.4 months, nearly six months longer than those on Pd alone, representing a benefit of 47.6%. Overall survival for Isa-Pd patients was 33.3 months, nearly double the 17.7 months for those on Pd alone.

临床3期临床结果

2024-11-12

·传奇生物

传奇生物公布2024年第三季度业绩及近期亮点

Legend Biotech ▶ CARVYKTI® (西达基奥仑赛；cilta-cel)更新：净贸易销售额约为2.86亿美元，营收同比增长87.6%，环比增长53.2%。与早至二线治疗的标准疗法相比，CARVYKTI®是目前首个且唯一能显著延长多发性骨髓瘤患者总生存期的细胞疗法。在国际骨髓瘤学会年会上公布了CARTITUDE-4三年随访数据。比利时根特Obelisc工厂开始商业化生产。第三季度在瑞士获批上市，并于近期将适应症扩展至用于治疗三线及以上多发性骨髓瘤患者。获得国家药品监督管理局（NMPA）批准用于治疗四线及以上多发性骨髓瘤患者。最近任命Alan Bash为CARVYKTI®总裁。 ▶ 宣布计划在费城新建最先进的细胞疗法研发设施。 ▶ 截至2024年9月30日，现金及现金等价物和定期存款达到12亿美元，传奇生物认为这些资金将提供直至2026年的财务储备，传奇生物预计在2026年实现经营利润。当地时间2024年11月12日，传奇生物（NASDAQ：LEGN）在美国新泽西州萨默塞特发布其2024年第三季度的未经审计财务业绩及公司主要亮点。黄颖博士传奇生物首席执行官我们对第三季度销售的强劲增长感到满意。在此期间，我们持续提升商业化能力并将CARVYKTI®带给全球更多的多发性骨髓瘤患者。来自CARTITUDE-4研究的积极数据进一步巩固了我们的竞争地位。与早至二线治疗的标准疗法相比，CARVYKTI®是目前首个且唯一能显著延长多发性骨髓瘤患者总生存期的细胞疗法。这凸显了此款疗法的变革性获益以及我们努力扩大患者可及性的重要性。为此，我们最近在比利时根特的Obelisc工厂启动了商业化生产，预计将有助于满足全球患者对CARVYKTI®的需求。作为长期战略的一部分，我们期待在进一步扩大产能的同时推进研发项目，以巩固传奇生物在细胞治疗创新领域的领导地位。监管更新中国国家药品监督管理局（NMPA）已批准西达基奥仑赛用于治疗既往接受过至少三线以上疗法（包括一种蛋白酶体抑制剂和一种免疫调节剂）的复发或难治性多发性骨髓瘤成人患者。瑞士药品监督管理局（Swissmedic）已批准扩大CARVYKTI®的适应症，用于治疗既往接受过至少二线以上疗法（包括免疫调节剂、蛋白酶体抑制剂和抗CD38抗体）且对来那度胺耐药的复发和难治性多发性骨髓瘤成人患者。主要业务进展已公布的3期CARTITUDE-4 研究的三年随访数据显示，CARVYKTI®显著延长了既往接受一种前线治疗的复发或难治性多发性骨髓瘤患者的总生存期，与标准疗法相比，死亡风险降低了45%。这些研究结果已在2024年国际骨髓瘤学会（IMS）年会的最新动态口头报告环节公布。传奇生物和杨森*计划与美国和欧盟监管机构分享这些结果，以支持更新潜在的适应症范围。获得批准并在比利时根特的新Obelisc工厂启动了CARVYKTI®的商业化生产，预计将有助于满足更多患者的需求。在第三季度于瑞士推出CARVYKTI®，这标志着CARVYKTI®已在第五个国家上市。宣布在宾夕法尼亚州费城建立一个先进的新研发设施，预计将于2025年第三季度完工，以扩展传奇生物在美国的现有研发布局，以推进其下一代细胞疗法产品管线。 *2017年12月，传奇生物与强生旗下杨森生物科技有限公司签订了一项全球独家合作及许可协议，以开发和商业化cilta-cel（杨森协议）。 2024年第三季度财务业绩许可证收入：截至2024年9月30日止三个月的许可收入为1710万美元，全部来自与诺华的许可协议；而截至2023年9月30日止三个月的许可收入为2010万美元，全部来自杨森协议下里程碑的达成。合作收入：截至2024年9月30日止三个月的合作收入为1.428亿美元，而截至2023年9月30日止三个月为7590万美元。这一增长主要是由于与杨森协议有关的CARVYKTI®销售收入增加。合作收入成本：截至2024年9月30日止三个月的合作收入成本为5250万美元，而截至2023年9月30日止三个月为4350万美元。增加的主要原因是CARVYKTI®的净贸易销售额增加。这一增长的主要原因是传奇生物在杨森协议下与CARVYKTI®销售相关的销售成本份额。许可及其他收入成本：截至2024年9月30日止三个月的许可及其他收入成本为300万美元，包括与诺华许可协议有关的成本。截至2023年9月30日的三个月，公司未产生任何许及其他收入成本。其他收入和收益：截至2024年9月30日止三个月的其他收入和收益为1680万美元，而截至2023年9月30日止三个月为3580万美元。减少1900万美元的主要原因是截至2024年9月30日止三个月没有未实现外汇收益，而截至2023年9月30日止三个月未实现外汇收益为1610万美元。研发开支：截至2024年9月30日止三个月的研发开支为9550万美元，而截至2023年9月30日止三个月为9590万美元。这一增长主要由持续西达基奥仑赛的研发活动所推动，包括在比利时进行临床生产的启动成本，以及传奇生物在实体瘤项目上的持续投资。行政开支：截至2024年9月30日止三个月的行政开支为3530万美元，而截至2023年9月30日的三个月为2810万美元。增长原因是由于扩大了行政职能和基础设施以提高生产能力。销售和分销开支：截至2024年9月30日止三个月的销售和分销开支为4430万美元，而截至2023年9月30日的三个月中，销售和分销费用为2110万美元。这一增长主要是由于与西达基奥仑赛商业活动相关的成本，包括扩大销售团队和推出二线适应症。其他开支：截至2024年9月30日止三个月的其他支出为6180万美元，而截至2023年9月30日止三个月为10万美元。这一增加几乎完全来自截至2024年9月30日的三个月中约6280万美元的未实现汇兑损失，其主要是与研发活动相关的美国和非美国法律实体之间的公司间交易和余额造成。截至2023年9月30日止三个月没有未实现汇兑损失。净亏损：截至2024年9月30日止三个月的净亏损为1.253亿美元，而截至2023年9月30日止三个月为6220万美元。现金状况：截至2024年9月30日，现金及现金等价物和定期存款为12亿美元，这些资金将提供直至2026年的财务储备，公司预计在2026年实现经营利润。网络直播/电话会议详情：传奇生物将于美国东部时间今天上午8:00举行季度业绩电话会议和网络直播。如观看网络直播，请点击页面左下角👉 “阅读原文”链接。网络直播重播将在传奇生物官方网站提供，网址为： https://investors.legendbiotech.com/events-and-presentations。关于传奇生物传奇生物（NASDAQ:LEGN）成立于2014年，是一家集肿瘤免疫细胞疗法研发、临床、生产及商业化开发于一体的跨国生物制药公司，位列全球免疫细胞疗法领域第一方阵，全球员工总数逾2000人。目前通过与杨森的合作，首款产品CARVYKTI®（cilta-cel，西达基奥仑赛）于2022年获得美国食品药品监督管理局（FDA）、日本厚生劳动省（MHLW）批准上市，并获得欧盟委员会（EC）附条件上市许可，有望解决多发性骨髓瘤治疗的世界级难题。2022年底，国家药品监督管理局正式受理西达基奥仑赛的新药上市申请（NDA），并于2023年1月纳入优先审评程序。此外，公司还有多款在研细胞疗法，用于血液瘤、实体瘤及其它疑难疾病的治疗。更多信息请访问：www.legendbiotech.cn 前瞻性说明本新闻稿中关于未来预期、计划和前景的陈述，以及关于非历史事实事项的任何其他陈述，均构成1995年《私人证券诉讼改革法案》所指的「前瞻性陈述」。这些陈述包括但不限于：与传奇生物的战略和目标有关的陈述；与CARVYKTI®有关的陈述，包括传奇生物对CARVYKTI®及其治疗潜力的预期；与CARVYKTI®可能被批准用于早期治疗线有关的陈述；有关传奇生物CARVYKTI®生产预期和2024年第三季度建成新研发设施的陈述; 有关传奇生有能力为2026年的运营提供资金的陈述;与传奇生物实现经营利润的能力有关的陈述；以及传奇生物候选产品的潜在优势。「预期」、「相信」、「继续」、「可能」、「估计」、「期望」、「打算」、「可以」、「计划」、「潜在」、「预测」、「预计」、「应该」、「目标」、「将」、「会」和类似表达旨在识别前瞻性陈述，但并非所有前瞻性陈述都包含这些识别词。由于各种重要因素，实际结果可能与此类前瞻性陈述所指的结果存在重大差异。传奇生物的期望可能会受到（其中包括）以下因素的影响：新药开发所涉及的不确定性；意外的临床试验结果，包括对现有临床数据或意外的新临床数据进行额外分析的结果；意外的监管行动或延误，包括要求提供额外的安全性和/或有效性数据或数据分析，或一般的政府监管；由于我们的第三方合作伙伴采取的行动或未能采取行动而导致的意外延误；由于传奇生物的专利或其他专有知识产权保护受到挑战而产生的不确定性，包括美国诉讼过程中涉及的不确定性；政府、行业和一般产品定价及其他政治压力；以及传奇生物于2024年3月19日向美国证券交易委员会提交的20-F表格年度报告的「风险因素」部分所讨论的其他因素。如果以上一项或多项风险或不确定性成为现实，或者如果基本假设被证明不正确，则实际结果可能与本新闻稿中所述的预期、相信、估计或期望的结果存在重大差异。本新闻稿中包含的任何前瞻性陈述仅代表截至本新闻稿发布之日的情况。传奇生物明确声明，无论是由于新信息、未来事件还是其他原因，均不承担更新任何前瞻性陈述的义务。

细胞疗法免疫疗法财报临床3期

100 项与来那度胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04687	来那度胺	L04AX04	DB00480

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
边缘区B细胞淋巴瘤	美国	Bristol Myers Squibb Co.	2019-05-28
成人T细胞白血病/淋巴瘤	日本	Bristol-Myers Squibb KK	2017-03-02
染色体5q缺失综合征	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
染色体5q缺失综合征	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
染色体5q缺失综合征	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
染色体5q缺失综合征	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
多发性骨髓瘤	美国	Bristol Myers Squibb Co.	2006-06-29
骨髓增生异常综合征	美国	Bristol Myers Squibb Co.	2005-12-27

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
浆细胞瘤	临床3期	美国	Biologics, Inc.	2015-12-01
浆细胞瘤	临床3期	美国	Millennium Pharmaceuticals, Inc.	2015-12-01
难治性弥漫性大B细胞淋巴瘤活化B细胞型	临床3期	美国	Celgene Corp.	2015-02-17
难治性弥漫性大B细胞淋巴瘤活化B细胞型	临床3期	中国	Celgene Corp.	2015-02-17
难治性弥漫性大B细胞淋巴瘤活化B细胞型	临床3期	日本	Celgene Corp.	2015-02-17
难治性弥漫性大B细胞淋巴瘤活化B细胞型	临床3期	澳大利亚	Celgene Corp.	2015-02-17
难治性弥漫性大B细胞淋巴瘤活化B细胞型	临床3期	比利时	Celgene Corp.	2015-02-17
难治性弥漫性大B细胞淋巴瘤活化B细胞型	临床3期	加拿大	Celgene Corp.	2015-02-17
难治性弥漫性大B细胞淋巴瘤活化B细胞型	临床3期	捷克	Celgene Corp.	2015-02-17
难治性弥漫性大B细胞淋巴瘤活化B细胞型	临床3期	法国	Celgene Corp.	2015-02-17

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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


ASH2024	N/A	多发性骨髓瘤	-	Ixazomib, Lenalidomide Plus Dexamethasone (IRd)	醖遞遞衊顧簾鏇醖窪襯(襯鹽鏇構簾餘廠襯壓遞) = 6(7.0%) pts in the IRd group 襯簾鹽繭衊築範網衊膚 (淵廠鑰蓋餘壓鹽製願齋 ) 更多	-	2024-12-09
ASH2024	N/A	多发性骨髓瘤	-	Bortezomib, Lenalidomide Plus Dexamethasone (VRd)		-	2024-12-09
ASH2024	N/A	复发性浆细胞骨髓瘤	-	Belantamab mafodotin 1.4 mg/kg	壓範醖繭鑰膚窪壓蓋積(鏇獵鏇夢蓋蓋膚鏇鬱衊) = 89.5% experienced blurred vision 淵鹹壓鹹網齋衊蓋獵觸 (醖夢願蓋餘選築鹽簾觸 ) 更多	-	2024-12-09
ASH2024	N/A	复发性浆细胞骨髓瘤	-	Belantamab mafodotin 1.9 mg/kg		-	2024-12-09
REST (ASH2024)	临床2期	多发性骨髓瘤一线	51	Isatuximab-Bortezomib-Lenalidomide-Dexamethasone	選憲襯築網觸網願製簾(範夢築構鑰繭憲積築壓) = 鹽構繭膚選醖顧鏇願觸鹹衊鑰遞獵淵衊獵構壓 (糧遞遞鹹衊願遞壓衊願, 82 ~ 99) 更多	积极	2024-12-09
NCT03319667 (IMROZ, ASH2024)	临床3期	多发性骨髓瘤	446	Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd)	廠繭鹹製廠衊鏇壓願鹽(膚鑰鹽齋艱糧鏇餘築憲) = 鑰壓觸淵鬱鬱艱獵鹽鏇構艱糧鏇積選衊鹹餘齋 (選鏇憲遞鹽膚遞繭鹹鑰 ) 更多	积极	2024-12-09
NCT03617731 (GMMG-HD7, ASH2024)	临床3期	多发性骨髓瘤 CD38	662	Isatuximab, Lenalidomide, Bortezomib, Dexamethasone	廠鹽鏇餘範壓夢鹹糧醖(夢衊蓋壓願觸願壓醖鬱) = 蓋齋餘淵憲遞選構廠鑰廠願窪構夢構壓鹹鏇廠 (壓糧鹹築醖鬱艱遞夢膚, 95% CI 0.52 ~ 0.94) 更多	积极	2024-12-09
NCT03617731 (GMMG-HD7, ASH2024)	临床3期	多发性骨髓瘤 CD38	662	Lenalidomide, Bortezomib, Dexamethasone	廠鹽鏇餘範壓夢鹹糧醖(夢衊蓋壓願觸願壓醖鬱) = 願窪獵壓獵鹽艱廠製鹽廠願窪構夢構壓鹹鏇廠 (壓糧鹹築醖鬱艱遞夢膚, 95% CI 46 ~ 48) 更多	积极	2024-12-09
ASH2024	N/A	多发性骨髓瘤	-	Lenalidomide	顧顧築膚鑰醖襯遞夢廠(願衊範觸積壓鏇簾淵壓) = 廠構糧襯淵齋顧醖憲窪選獵選膚憲憲鑰醖獵觸 (夢壓鬱選網糧鏇鏇選齋, 1 ~ 12)	-	2024-12-09
ASH2024	N/A	多发性骨髓瘤	78	CyBorD induction + HD-Mel + single ASCT + lenalidomide maintenance	夢壓憲衊鹹顧構醖製網(鬱襯築艱夢齋淵憲膚製) = 醖蓋衊憲網膚鏇餘窪廠糧繭壓齋遞顧網鑰積廠 (築網廠蓋構膚範壓夢鹽, 70 ~ 88) 更多	积极	2024-12-08
ASH2024	N/A	多发性骨髓瘤	-	Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd)	範醖廠選醖蓋淵範鏇遞(構壓襯鏇鬱鹽衊鏇鹽壓) = 廠觸範淵築選壓鏇製夢壓窪廠窪壓蓋憲襯築簾 (顧顧積鹹遞顧鹽窪蓋餘 ) 更多	-	2024-12-08
ASH2024	N/A	多发性骨髓瘤	-	DVRd-DR	範醖廠選醖蓋淵範鏇遞(構壓襯鏇鬱鹽衊鏇鹽壓) = 衊遞構遞糧艱積構齋觸壓窪廠窪壓蓋憲襯築簾 (顧顧積鹹遞顧鹽窪蓋餘 ) 更多	-	2024-12-08
ASH2024	N/A	多发性骨髓瘤	-	Daratumumab, Lenalidomide, Bortezomib, Dexamethasone (D-RVd)	選構餘鑰鹹願願鑰衊範(衊醖壓壓構選齋衊選顧) = 82% 鬱範積遞夢齋範壓醖淵 (選鏇衊選願壓壓膚網願 ) 更多	-	2024-12-08
ASH2024	N/A	多发性骨髓瘤	-	Lenalidomide	獵鏇鏇顧鹹鹽願襯願顧(鏇糧選簾願築窪襯鹽獵) = 鑰襯選夢範襯積窪繭餘製艱憲鏇廠淵壓蓋襯襯 (鹽遞範鬱壓壓窪窪膚鬱 ) 更多	-	2024-12-08