This phase II trial studies how well prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans (in combination with bone scans) work in selecting patients for Ra-223 radiation therapy that have castration-resistant prostate cancer that has spread from where it first started (primary site) to the bones (bone metastasis). Ra-223 is a type of therapy that emits radiation. Radiation gives off energy which can kill tumor cells and other cells that may support the tumor cells. Ra-223 is given by infusion into the veins, where it is absorbed by the bones. PSMA PET is a type of scan used to detect prostate cancer tumors. PSMA is a radioactive tracer that binds to a specific protein that is found on prostate tumor cells. The PSMA tracer shows the areas on the PET scan where tumor cells are active. A PET scan uses a special camera to detect the energy given off from radioactive tracers (such as PSMA) to make detailed pictures of areas where the tracer accumulates in the body. The PET scan is often combined with a magnetic resonance imaging (MRI) or computed tomography (CT) scan, which helps to map the locations where PSMA has accumulated. PSMA PET scans may be able to select patients that will benefit the most from Ra-223 treatment.

开始日期2024-08-30

申办/合作机构

The University of California, San Francisco

[+1]

NL-OMON56209 / SuspendedN/A

A FEASIBILITY STUDY OF 177LU-PSMA RADIOLIGAND THERAPY ALTERNATED WITH RADIUM-223 IN PATIENTS WITH BONE-METASTATIC, OLIGO-METASTATIC HORMONE-SENSITIVE PROSTATE CANCER AFTER CURATIVE THERAPY. THE DUET STUDY - DUET trial

开始日期2023-12-01

申办/合作机构

Amsterdam University Medical Center

NCT05771896 / Withdrawn临床3期

A Phase III Randomized Study Comparing the Combination of Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With Metastatic Castration-Sensitive Prostrate Cancer (mCSPC)

The goal of this clinical trial is to compare the combination of Darolutamide with Radium-223 or placebo and the effects on radiological progression-free survival for patients with Metastatic Castration-Sensitive Prostrate Cancer (mCSPC)
The main questions it aims to answer are:
Radiological progression-free survival (rPFS) in mCSPC
Overall Survival (OS)
Symptomatic skeletal event-free survival (SSE-FS)
Initiation of subsequent antineoplastic therapy
Safety
Participants will have visits at baseline, treatment is once a month for up to 6 months, and long term follow up will continue until the participant dies, withdraws consent, and/or study is terminated.

开始日期2023-09-01

申办/合作机构

GenesisCare USA Holdings, Inc.

[+1]

100 项与二氯化镭[223Ra] 相关的临床结果

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100 项与二氯化镭[223Ra] 相关的转化医学

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100 项与二氯化镭[223Ra] 相关的专利（医药）

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829

项与二氯化镭[223Ra] 相关的文献（医药）

2025-01-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Targets for improving prostate tumor response to radiotherapy

Review

作者: Li, Fengguang ; Jiang, Maozhu ; Zhang, Haiying ; Maozhu jiang ; Yu, Yizhi

Prostate cancer is a prevalent malignancy that is frequently managed with radiotherapy. However, resistance to radiotherapy remains a significant challenge in controlling this disease. Early radiotherapy is employed for locally confined prostate cancer (PCa), while recurrent disease post-surgery and metastatic castration-resistant prostate cancer (mCRPC) are treated with late-stage radiotherapy, including radium-223. Combination therapies to integrate radiotherapy and chemotherapy have demonstrated enhanced treatment efficacy. Nonetheless, both modalities can induce severe local and systemic toxicities. Consequently, selectively sensitizing prostate tumors to radiotherapy could improve therapeutic outcomes while minimizing systemic side effects. The mechanisms underlying radioresistance in prostate cancer are multifaceted, including DNA damage repair (DDR) pathways, hypoxia, angiogenesis, androgen receptor (AR) signaling, and immune evasion. The advent of 177Lu-PSMA-617, which was approved in 2022, has shown promise in targeting prostate-specific membrane antigen (PSMA) in advanced prostate cancer. Experimental and clinical studies have yielded promising results in suppressing prostate tumors by targeting these pathways. This paper reviews potential targets for sensitizing prostate tumors to radiotherapy. We discuss cellular and molecular mechanisms contributing to therapy resistance and examine findings from experimental and clinical trials on promising targets and drugs that can be used in combination with radiotherapy.

2024-12-01·American journal of ophthalmology case reports

Bilateral neovascular glaucoma associated with Radium-223 infusions for prostate cancer

Article

作者: Rho, Jonathan Y. ; Rho, Jonathan Y ; Viscardi, Chelsea M ; Blake, Charles R. ; Viscardi, Chelsea M. ; Blake, Charles R

Purpose:

To report two cases of neovascular glaucoma associated with Radium-223 infusion.

Observations:

Presented are two patients with metastatic prostate cancer who developed uncontrolled intraocular pressure secondary to neovascular glaucoma requiring surgical intervention. Both patients had received six cycles of Radium-223, a calcium mimetic that causes DNA double strand breaks and tumor cell death in bony metastases as part of their treatment regimen for metastatic prostate cancer. One patient had been a prior glaucoma suspect while the other had no significant ocular history.

Conclusions and importance:

Radium-223 may increase vascular permeability contributing to uveitis and promote angiostimulatory growth factors that can lead to neovascularization. We postulate this is through possible disruption in VEGF signaling pathways as well as Ra-223's calcium mimetic properties that could affect the trabecular meshwork. Neovascular glaucoma is uncommonly reported with Ra-223. There is one other case report that experienced uveitis and hyphema within weeks of the Ra-223 infusion. This case report has a similar proposed biologic mechanism. A literature review using the key words "radium-223, neovascularization, secondary angle closure glaucoma, neovascular glaucoma" did not yield any prior reports of neovascular glaucoma associated with Ra-223. The goal of this case series is to argue there is biological plausibility and to contribute to current literature of possible ocular complications of Ra-223 infusion.

2024-12-01·IEEE TRANSACTIONS ON MEDICAL IMAGING

Joint Regional Uptake Quantification of Thorium-227 and Radium-223 Using a Multiple-Energy-Window Projection-Domain Quantitative SPECT Method

Article

作者: Benabdallah, Nadia ; Thorek, Daniel L. J. ; Wahl, Richard L. ; Jha, Abhinav K. ; Laforest, Richard ; Li, Zekun

Thorium-227 (²²⁷Th)-based α-particle radiopharmaceutical therapies (α-RPTs) are currently being investigated in several clinical and pre-clinical studies. After administration, ²²⁷Th decays to ²²³Ra, another α-particle-emitting isotope, which redistributes within the patient. Reliable dose quantification of both ²²⁷Th and ²²³Ra is clinically important, and SPECT may perform this quantification as these isotopes also emit X- and γ-ray photons. However, reliable quantification is challenging for several reasons: the orders-of-magnitude lower activity compared to conventional SPECT, resulting in a very low number of detected counts, the presence of multiple photopeaks, substantial overlap in the emission spectra of these isotopes, and the image-degrading effects in SPECT. To address these issues, we propose a multiple-energy-window projection-domain quantification (MEW-PDQ) method that jointly estimates the regional activity uptake of both ²²⁷Th and ²²³Ra directly using the SPECT projection data from multiple energy windows. We evaluated the method with realistic simulation studies conducted with anthropomorphic digital phantoms, including a virtual imaging trial, in the context of imaging patients with bone metastases of prostate cancer who were treated with ²²⁷Th-based α-RPTs. The proposed method yielded reliable (accurate and precise) regional uptake estimates of both isotopes and outperformed state-of-the-art methods across different lesion sizes and contrasts, as well as in the virtual imaging trial. This reliable performance was also observed with moderate levels of intra-regional heterogeneous uptake as well as when there were moderate inaccuracies in the definitions of the support of various regions. Additionally, we demonstrated the effectiveness of using multiple energy windows and the variance of the estimated uptake using the proposed method approached the Cramér-Rao-lower-bound-defined theoretical limit. These results provide strong evidence in support of this method for reliable uptake quantification in ²²⁷Th-based α-RPTs.

110

项与二氯化镭[223Ra] 相关的新闻（医药）

2024-12-03

·GlobeNewswire-Health Care

Nusano Names Medical Radioisotopes Advisory Board

VALENCIA, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Nusano, a physics company transforming the production of radioisotopes, today announced the creation of a Medical Radioisotopes Advisory Board. This panel of internationally recognized leaders in nuclear medicine will provide strategic guidance to Nusano, ensuring its product development aligns with emerging trends and with the needs of cancer patients. The board will also guide the development of isotopes for next-generation theranostic compounds. “As a radioisotope producer, Nusano plays a critical role in the supply chains of drug developers, healthcare providers and researchers,” said Chris Lowe, CEO of Nusano. “Establishing a Medical Radioisotopes Advisory Board reflects our ongoing commitment to proactively enabling the next generation of oncology research. The board’s guidance will ensure Nusano is providing a stable and scalable supply of isotopes for new areas of research and patient care.” Radioisotopes are essential components in the active pharmaceutical ingredients (API) used in new and emerging cancer therapies including molecular radiation. Existing supply chains for these treatment-enabling resources are often strained, posing a risk to patient care, clinical trials, and ongoing drug development. Nusano is working to stabilize supply chains and enable innovation by bringing new sources of radioisotopes to multiple markets. Opening in 2025 in West Valley City, Utah, the Nusano production platform will be capable of generating more than 40 radioisotopes applicable to medical and industrial uses. It is anchored by a proprietary ion source technology which accelerates heavy particles (alphas and deuterons) to generate high volume, high quality (CGMP-grade) radioisotopes with unparalleled efficiency using eco-friendly methods. The result is one of the first significant advancements in radioisotope production in decades. The five members of the Nusano advisory board are (listed alphabetically by last name): Munir GhesaniMunir Ghesani, MD, FACNM, FACR, FSNMMI, is the Medical Director of United Theranostics in Princeton and the Chief Medical Officer of United Theranostics. He previously served as the Systems Chief of Nuclear Medicine and Molecular Imaging at Mount Sinai Health System in New York. Dr. Ghesani has been actively involved in clinical practice, research, clinical trials, and education for over 25 years, primarily focusing on nuclear medicine, molecular imaging, and targeted radiopharmaceutical therapies. Dr. Ghesani has authored more than 200 publications in peer-reviewed journals and is the Editor-in-Chief of a three-part book on nuclear medicine and molecular imaging. He has delivered over 150 presentations at regional, national, and international conferences. Dr. Ghesani has held leadership roles in various societies and colleges, including Immediate Past President of the Society of Nuclear Medicine and Molecular Imaging (SNMMI), Past-President of the Education and Research Foundation of Nuclear Medicine and Molecular Imaging, Past Chairman of the American Board of Nuclear Medicine, Past Chairman of the Government Relations Committee, and the FDA Task Force of the SNMMI, as well as Past Chairman of the Nuclear Medicine and PET Accreditation Committee of the American College of Radiology. In January 2020, he was awarded the ACNM Personal Best Mentor of the Year. He has also been recognized as a Fellow of the American College of Nuclear Medicine (2006), the American College of Radiology (2018), and the Society of Nuclear Medicine and Molecular Imaging (2023). Suzanne LapiSuzanne E. Lapi, Ph.D. is the Emmet O’Neal II Professor, O’Neal Comprehensive Cancer Center and Professor of Radiology and Chemistry and Cyclotron Facility Director at the University of Alabama at Birmingham. She is also the Vice Chair of Research in the Department of Radiology. Her research interests are in the development and translation of new PET radionuclides and molecular imaging agents. She has over 150 publications and is principal investigator on active research grants from the National Institutes of Health (NIH) and United States Department of Energy (DOE), as well as industry partners. She oversees production of PET radionuclides and imaging radiopharmaceuticals for preclinical research and clinical trials. Her group holds more than 15 approved INDs and supplies Cu-64, Zr-89, Mn-52 and other isotopes to groups across the USA and internationally. She is a Fellow of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and a strong advocate of radiopharmaceutical sciences and the training of future nuclear and radiochemists at the graduate, postdoctoral and faculty levels. Luke NordquistThe CEO of the XCancer® Organization, Dr. Luke Nordquist is a practicing Medical Oncologist with an expertise in prostate cancer. Nordquist’s Community Cancer Center in Omaha, Neb. is internationally known, gaining recognition for its participation in early and late phase radiopharmaceutical trials of Ra-223, Lu-177, Ac-225, Th-227, Pb-212, Zr89, In111, Cu-64, and Cu-67. Nordquist and his XCancer team have conducted over 40 imaging & therapeutic Theranostic trials to date including 22 Firsts-in-World trials. His research program is recognized for rapid start-ups, high accruals, and exceptional data timeliness and quality. Dr. Nordquist is also the Founder of TheranosticTrials.Org, a digital platform increasing education and access of global Theranostic trials. Through his XCancer® Research Network, Nordquist is working to provide access to cutting edge clinical trials closer to home. In so doing, he and his collaborators are to increase community cancer center participation and drive improved access for cancer patients regardless of geography. Philip KooDr. Koo is the Chief of Diagnostic Imaging at the Banner MD Anderson Cancer Center in Phoenix, AZ. Prior to this, he was Chief of Nuclear Medicine and Associate Professor of Radiology at the University of Colorado School of Medicine. Dr. Koo completed his transitional internship at the University of Pennsylvania Medical Center-Presbyterian, radiology residency at Pennsylvania Hospital of the University of Pennsylvania Health System, and fellowship at the Harvard Medical School Joint Program in Nuclear Medicine. He is a diplomate of both the American Board of Radiology (ABR) and American Board of Nuclear Medicine. Dr. Koo’s academic interests have focused on nuclear medicine in prostate cancer and response to novel therapies using PET, with over 80 peer reviewed publications and abstracts. He has lectured nationally and internationally on topics related to imaging and radiopharmaceutical based therapies in prostate cancer. Dr. Koo is the Founding Chair of the SNMMI Therapeutics Conference and received the SNMMI Presidential Distinguished Service Award in 2022. Neal ShoreNeal Shore, MD, FACS, graduated from Duke University and Duke University Medical School. He completed his general surgery/urology residency at New York Hospital-Cornell Medical Center/Memorial Sloan Kettering Cancer Center. He serves as the Medical Director for the Carolina Urologic Research Center. Dr. Shore has conducted more than 400 clinical trials, focusing mainly on genitourinary oncology, and has authored more than 350 peer-reviewed publications and numerous book chapters. He serves on the Society for Immunotherapy of Cancer (SITC) Guidelines Committee for Bladder Cancer, as well as the boards of the Bladder Cancer Advocacy Network, the APCCC Scientific Steering Committee, Maple Tree Cancer Alliance, and the Duke Global Health Institute. He is the Chair of both the Prostate Cancer Academy and the Bladder/Kidney Cancer Academy, and the co-chair of the annual AUA International Prostate Forum. He has served/serves on the editorial boards of Reviews in Urology, Urology Times, Chemotherapy Advisor, OncLive, PLOS ONE, Urology Practice, JUOP, Everyday Urology Oncology and World Journal of Urology. He is the Editor-in-Chief of Reviews in Urology. He is a Fellow of the American College of Surgeons and a Certified Physician Investigator. About NusanoNusano is a privately held physics company committed to bringing supply stability and innovation to the rapidly emerging and critically undersupplied medical radioisotopes market, and to serving industrial and commercial markets dependent on reliable access to high quality radioisotopes for their products and services. Driven by the company’s proprietary ion source, the Nusano production platform will generate radioisotopes in volumes and varieties exceeding other production methods. Nusano’s breakthrough technologies are poised to help supply the fight against cancer and enable innovation across multiple industries. For more, please visit nusano.com. Contacts: Media: Scott Larrivee, Nusano, 608-345-6629, scott.larrivee@nusano.comInvestor Relations: Joyce Allaire, LifeSci Advisors, LLC, 212-915-2569, jallaire@lifesciadvisors.com

高管变更

2024-11-11

·美通社

拜耳特药携肿瘤和眼科多项成果七赴进博会

上海 2024年11月11日 /美通社/ -- 作为创新发展的关键窗口与推动高水平开放的重要平台，第七届中国国际进口博览会（以下简称"进博会"）圆满收官。作为连续七年参展的"进博老友"，拜耳处方药事业部特药业务在本届进博会上带来了多款创新药物的最新进展，集中展示了其在肿瘤和眼科两大治疗领域的多项前沿突破，以丰富的产品组合续写创新篇章，以实际行动彰显拜耳对中国市场的信心，助力"健康中国2030"早日实现。与此同时，借助进博会平台作用，拜耳还与本土行业伙伴、专家学会、权威媒体等各方加强合作，在肿瘤防治领域开展各项学术项目和社会活动，共同探索新未来。创新植根中国，共享健康未来第七届进博会上的拜耳处方药展台前列腺癌作为拜耳在中国开启的全新治疗领域，已经上市了两款前列腺癌治疗药物多菲戈 ® 和诺倍戈 ® ，为处于不同疾病阶段的中国前列腺癌患者带来多重获益。此次进博会期间，拜耳带来了诺倍戈 ® 的最新试验结果。今年7月刚刚公布的ARANOTE III期试验结果显示，诺倍戈 ® 联合雄激素剥夺疗法（ADT）的二联疗法显著提高了影像学无进展生存期（rPFS），显著降低了mHSPC患者的46%的影像学进展或死亡风险，次要终点均显示获益趋势，且安全性数据与对照组相当。目前，拜耳已先后向美国和欧盟递交诺倍戈 ® 第三个适应症的上市申请，并计划在全球范围内，将该研究的数据提交给卫生监管部门，以扩大诺倍戈 ® 在mHSPC男性患者中的使用，为临床医生提供兼具疗效与安全性、病程覆盖广、灵活性更高的创新治疗模式。此外，多菲戈 ® 联合恩扎卢胺的PEACE 3最新数据使得mCRPC患者的生存迈向新高度，中位OS长达42.3个月，给患者提供了更多的治疗选择。另一款在进博会展示的创新药，是拜耳针对肺癌研发的新型靶向治疗药物BAY 2927088。该药是拜耳在研的一款酪氨酸激酶抑制剂，作为一种潜在的新型靶向药物被开发用于治疗携带HER2激活突变的非小细胞肺癌（NSCLC）患者。 HER2已被证实可作为NSCLC的治疗靶点，但目前对于携带HER2激活突变的转移性或晚期NSCLC患者，尚未有获得完全批准的可用疗法。而早期临床证据显示，BAY 2927088有可能使携带HER2突变的，既往系统治疗后疾病发生进展的NSCLC患者受益。今年2月和6月，BAY 2927088已先后获得美国FDA突破性疗法认定，以及中国国家药品监督管理局药品审评中心（CDE）突破性治疗品种认定，适应症为适用于治疗携带HER2激活突变且既往接受过一种全身性治疗的不可切除或转移性非小细胞肺癌（NSCLC）成人患者。另外，用于眼科治疗的Eylea TM 8mg在欧盟获批后再次亮相本届进博会。新生血管（湿性）年龄相关性黄斑变性（nAMD）是一种进展迅速的眼病，如果不及时治疗，可在短短三个月内导致视力丧失。全世界有1.96亿人患有AMD，预计到2040年这一数字将增至2. 88亿。大约10%的AMD患者会发展到nAMD类型。糖尿病性黄斑水肿（DME）是糖尿病患者眼睛中常见的并发症，全球约2700万人患有DME。在此背景下，Eylea TM 8mg是在欧盟、英国和日本等主要市场目前唯一一种获批治疗间隔最长可达5个月的nAMD和DME抗血管内皮生长因子（VEGF）治疗药物。今年1月，国家药品监督管理局药品评审中心受理Eylea TM 8mg用于nAMD的上市申请。与Eylea ® 2mg相比，Eylea TM 8mg已证明对绝大多数患者具有更强的持久性，从而延长治疗间隔、减少注射次数，并进而增加治疗依从性和减轻患者负担。携手医疗"朋友圈"，共筑肿瘤防治新未来作为连续七年参展的"进博老友"，今年拜耳不仅在现场呈现了众多创新解决方案与临床研究突破，也继续借助进博舞台，携手志同道合的合作伙伴，在肿瘤防治领域积极开展和支持各项学术项目和社会活动，探寻新发展与新未来。消化系统肿瘤尤其是肝癌一直是拜耳的优势治疗领域。十七年前，多吉美 ® 的上市正式开启了肝癌靶向治疗时代。在多吉美 ® 独领风骚10年后，拜万戈 ® 作为标准的肝癌二线靶向治疗药物在国内正式获批，再度重塑肝癌系统治疗全程管理新格局。多吉美 ® 和拜万戈 ® 不断延长患者生存期，为患者带来生的希望。今年进博会期间，"肝癌防治体系行动成果发布"、"《原发性肝癌一线耐药后规范化治疗专家共识》启动发布会"以及"CHANCE012拜万戈中国最大样本量研究数据收集阶段性完成庆祝仪式"肝癌系列主题活动在拜耳展台上成功举行，集中展示了拜耳在肝癌防治领域的最新进展和重要成果，助力中国肝癌防治领域的高质量发展。肝癌防治体系行动阶段性成果发布每年的11月是"男性健康月"。作为全球第二常见男性肿瘤，前列腺癌是该活动的重要议题之一。今年，拜耳借助进博会的重要平台，携手《生命时报》社共同发起"男性健康月——前列腺癌全程管理科普行动"，支持由《丁香园》发起的"前列腺癌骨转移答案书"发布，以呼吁全社会关注男性健康，推进前列腺癌的早防早治与规范化全程管理。男性健康月-前列腺癌全程管理科普行动于第七届进博会期间成功举办在精准治疗领域，拜耳拥有全球首个口服TRK抑制剂维泰凯 ® ，它是专门用于治疗具有NTRK基因融合成人和儿童实体瘤的不限瘤种精准靶向治疗药物，自2022年在国内上市，开启了"异癌同治"的肿瘤精准治疗新格局。本届进博会上，拜耳邀请业内肿瘤专家、基因检测公司以及患者组织等多方代表，共同探讨当下泛肿瘤治疗领域罕见靶点精准诊疗的现状和前景，探索如何发挥各自优势，汇聚多方合力落地中国本土实践，携手推动中国精准诊疗的检测率、治疗率全面提升。拜耳集团处方药事业部副总裁，特药业务总经理杨玉兰女士表示："站在新起点，拜耳将继续把握开放合作的进博机遇，持续践行‘在中国，为中国'的长期承诺，全面助力中国医疗健康行业高质量发展，并将始终秉承‘以患者为中心'，在大力发展创新药物的同时，保障创新药物可及性，同绘‘健康中国2030'宏伟蓝图，加速推动‘健康中国'的到来。" 关于拜耳拜耳作为一家跨国企业，在生命科学领域的健康与农业方面具有核心竞争力。秉承"共享健康，消除饥饿"的使命，公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2023财年，拜耳的员工人数约为100,000名，销售额为476亿欧元，不计特殊项目的研究开发投入为54亿欧元。更多信息请见 www.bayer.com。前瞻性声明本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站 www.bayer.com上公开的拜耳各项报告中。拜耳没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。

临床3期突破性疗法临床1期

2024-11-10

·拜耳中国

拜耳特药业务携多项创新成果七赴进博会，助力中国肿瘤和眼科防治新发展

11月10日，作为创新发展的关键窗口与推动高水平开放的重要平台，第七届中国国际进口博览会（以下简称“进博会”）迎来收官。作为连续七年参展的“进博老友”，拜耳处方药事业部特药业务在本届进博会上带来了多款创新药物的最新进展，集中展示了其在肿瘤和眼科两大治疗领域的多项前沿突破，以丰富的产品组合续写创新篇章，以实际行动彰显拜耳对中国市场的信心，助力“健康中国2030”早日实现。与此同时，借助进博会平台作用，拜耳还与本土行业伙伴、专家学会、权威媒体等各方加强合作，在肿瘤防治领域开展各项学术项目和社会活动，共同探索新未来。创新植根中国，共享健康未来第七届进博会上的拜耳处方药展台前列腺癌作为拜耳在中国开启的全新治疗领域，已经上市了两款前列腺癌治疗药物多菲戈®和诺倍戈®，为处于不同疾病阶段的中国前列腺癌患者带来多重获益。此次进博会期间，拜耳带来了诺倍戈®的最新试验结果。今年7月刚刚公布的ARANOTE III期试验结果显示，诺倍戈®联合雄激素剥夺疗法（ADT）的二联疗法显著提高了影像学无进展生存期（rPFS），显著降低了mHSPC患者的46%的影像学进展或死亡风险，次要终点均显示获益趋势，且安全性数据与对照组相当。目前，拜耳已先后向美国和欧盟递交诺倍戈®第三个适应症的上市申请，并计划在全球范围内，将该研究的数据提交给卫生监管部门，以扩大诺倍戈®在mHSPC男性患者中的使用，为临床医生提供兼具疗效与安全性、病程覆盖广、灵活性更高的创新治疗模式。此外，多菲戈®联合恩扎卢胺的PEACE 3最新数据使得mCRPC患者的生存迈向新高度，中位OS长达42.3个月，给患者提供了更多的治疗选择。另一款在进博会展示的创新药，是拜耳针对肺癌研发的新型靶向治疗药物BAY 2927088。该药是拜耳在研的一款酪氨酸激酶抑制剂，作为一种潜在的新型靶向药物被开发用于治疗携带HER2激活突变的非小细胞肺癌（NSCLC）患者。 HER2已被证实可作为NSCLC的治疗靶点，但目前对于携带HER2激活突变的转移性或晚期NSCLC患者，尚未有获得完全批准的可用疗法。而早期临床证据显示，BAY 2927088有可能使携带HER2突变的，既往系统治疗后疾病发生进展的NSCLC患者受益。今年2月和6月，BAY 2927088已先后获得美国FDA突破性疗法认定，以及中国国家药品监督管理局药品审评中心（CDE）突破性治疗品种认定，适应症为适用于治疗携带HER2激活突变且既往接受过一种全身性治疗的不可切除或转移性非小细胞肺癌（NSCLC）成人患者。工作人员介绍拜耳肿瘤治疗领域创新产品另外，用于眼科治疗的EyleaTM 8mg在欧盟获批后再次亮相本届进博会。新生血管（湿性）年龄相关性黄斑变性（nAMD）是一种进展迅速的眼病，如果不及时治疗，可在短短三个月内导致视力丧失。全世界有1.96亿人患有AMD，预计到2040年这一数字将增至2. 88亿。大约10%的AMD患者会发展到nAMD类型。糖尿病性黄斑水肿（DME）是糖尿病患者眼睛中常见的并发症，全球约2700万人患有DME。在此背景下，EyleaTM 8mg是在欧盟、英国和日本等主要市场目前唯一一种获批治疗间隔最长可达5个月的nAMD和DME抗血管内皮生长因子（VEGF）治疗药物。今年1月，国家药品监督管理局药品评审中心受理EyleaTM 8mg用于nAMD的上市申请。与Eylea® 2mg相比，EyleaTM 8mg已证明对绝大多数患者具有更强的持久性，从而延长治疗间隔、减少注射次数，并进而增加治疗依从性和减轻患者负担。携手医疗“朋友圈”，共筑肿瘤防治新未来作为连续七年参展的“进博老友”，今年拜耳不仅在现场呈现了众多创新解决方案与临床研究突破，也继续借助进博舞台，携手志同道合的合作伙伴，在肿瘤防治领域积极开展和支持各项学术项目和社会活动，探寻新发展与新未来。消化系统肿瘤尤其是肝癌一直是拜耳的优势治疗领域。十七年前，多吉美®的上市正式开启了肝癌靶向治疗时代。在多吉美®独领风骚10年后，拜万戈®作为标准的肝癌二线靶向治疗药物在国内正式获批，再度重塑肝癌系统治疗全程管理新格局。多吉美®和拜万戈®不断延长患者生存期，为患者带来生的希望。今年进博会期间，“肝癌防治体系行动成果发布”、“《原发性肝癌一线耐药后规范化治疗专家共识》启动发布会”以及“CHANCE012拜万戈中国最大样本量研究数据收集阶段性完成庆祝仪式”肝癌系列主题活动在拜耳展台上成功举行，集中展示了拜耳在肝癌防治领域的最新进展和重要成果，助力中国肝癌防治领域的高质量发展。肝癌防治体系行动阶段性成果发布每年的11月是“男性健康月”。作为全球第二常见男性肿瘤，前列腺癌是该活动的重要议题之一。今年，拜耳借助进博会的重要平台，携手《生命时报》社共同发起“男性健康月——前列腺癌全程管理科普行动”，支持由《丁香园》发起的“前列腺癌骨转移答案书”发布，以呼吁全社会关注男性健康，推进前列腺癌的早防早治与规范化全程管理。男性健康月-前列腺癌全程管理科普行动于第七届进博会期间成功举办在精准治疗领域，拜耳拥有全球首个口服TRK抑制剂维泰凯®，它是专门用于治疗具有NTRK基因融合成人和儿童实体瘤的不限瘤种精准靶向治疗药物，自2022年在国内上市，开启了“异癌同治”的肿瘤精准治疗新格局。本届进博会上，拜耳邀请业内肿瘤专家、基因检测公司以及患者组织等多方代表，共同探讨当下泛肿瘤治疗领域罕见靶点精准诊疗的现状和前景，探索如何发挥各自优势，汇聚多方合力落地中国本土实践，携手推动中国精准诊疗的检测率、治疗率全面提升。拜耳集团处方药事业部副总裁，特药业务总经理杨玉兰女士表示：“站在新起点，拜耳将继续把握开放合作的进博机遇，持续践行‘在中国，为中国’的长期承诺，全面助力中国医疗健康行业高质量发展，并将始终秉承‘以患者为中心’，在大力发展创新药物的同时，保障创新药物可及性，同绘‘健康中国2030’宏伟蓝图，加速推动‘健康中国’的到来。” 关于拜耳拜耳作为一家跨国企业，在生命科学领域的健康与农业方面具有核心竞争力。公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2023财年，拜耳的员工人数约为100,000名，销售额为476亿欧元。不计特殊项目的研究开发投入为58亿欧元。更多信息请见www.bayer.com。前瞻性声明本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站http://www.bayer.com/上公开的拜耳各项报告。本公司没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。

突破性疗法临床3期申请上市临床1期

100 项与二氯化镭[223Ra] 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	二氯化镭[223Ra]	V10XX03	DB08913

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
前列腺癌	中国	Institute For Energy Technology	2020-08-26
骨转移癌	欧盟	Bayer AG	2013-11-13
骨转移癌	冰岛	Bayer AG	2013-11-13
骨转移癌	列支敦士登	Bayer AG	2013-11-13
骨转移癌	挪威	Bayer AG	2013-11-13
去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2013-05-15

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
去势敏感前列腺癌	临床3期	-	Bayer AG	2023-09-01
转移性前列腺癌	临床3期	-	Bayer AG	2023-09-01
转移性去势抵抗性前列腺癌	临床3期	中国	Bayer AG	2013-03-26
转移性去势抵抗性前列腺癌	临床3期	新加坡	Bayer AG	2013-03-26
转移性去势抵抗性前列腺癌	临床3期	韩国	Bayer AG	2013-03-26
转移性去势抵抗性前列腺癌	临床3期	中国台湾	Bayer AG	2013-03-26
寡转移性前列腺癌	临床2期	美国	Bayer AG	2019-08-09
复发性多发性骨髓瘤	临床2期	美国	Bayer AG	2016-10-01
复发性多发性骨髓瘤	临床2期	澳大利亚	Bayer AG	2016-10-01
复发性多发性骨髓瘤	临床2期	比利时	Bayer AG	2016-10-01

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临床结果

适应症

分期

评价

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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


NCT03996473 (CTgov)	临床1期	转移性非小细胞肺癌	8	Radium-223 Dichloride+Pembrolizumab (Radium-223 Dichloride + Pembrolizumab)	餘夢憲鑰憲壓觸憲壓鏇(醖鑰鹽壓鹽壓顧製廠鏇) = 餘獵淵鏇醖範積簾鹽鑰醖網憲鏇衊築醖醖願糧 (膚艱鏇範齋蓋觸選網膚, 鏇願襯鏇鬱製壓網築鬱 ~ 餘憲齋網襯齋襯醖鏇膚) 更多	-	2024-10-10
				Radium-223+Pembrolizumab (Radium-223 + Pembrolizumab)	夢鏇廠艱築餘窪醖積鹽(襯築襯襯齋築製窪淵膚) = 選壓鹹鑰製繭夢構觸齋獵憲淵艱鬱顧壓窪蓋獵 (選範鑰獵積衊夢衊窪獵, 鏇獵廠糧範鑰鬱鹹夢廠 ~ 餘醖鏇夢醖衊淵觸遞選) 更多
ASTRO	N/A	寡转移性前列腺癌	-	RAdium-223 (Stereotactic ablative radiation (SABR))	鬱網範夢選糧選淵夢醖(繭鑰積壓壓夢壓鏇齋積) = 13 patients (20%) experienced grade 3 toxicity (no grade 4 or 5), of which 6 were non-treatment-related, 2 related to SABR, and 5 related to SABR/Ra223 (lymphopenia, back pain) 衊遞淵廠衊範鏇製蓋淵 (網選觸遞獵蓋網繭艱構 )	-	2024-10-01
NCT02141438 (REASSURE, Pubmed \| Cancer)	N/A	转移性去势抵抗性前列腺癌	182	Radium-223 + Immediate Taxane Chemotherapy	餘願獵積壓蓋艱憲遞構(艱構醖簾簾繭糧築鹽簾) = 夢壓淵簾壓鏇衊願糧淵遞餘鬱顧艱廠蓋艱範廠 (壓衊範繭獵齋獵繭願窪 )	积极	2024-06-01
				Radium-223 + Delayed Taxane Chemotherapy	餘願獵積壓蓋艱憲遞構(艱構醖簾簾繭糧築鹽簾) = 簾壓觸齋膚構衊遞糧餘遞餘鬱顧艱廠蓋艱範廠 (壓衊範繭獵齋獵繭願窪 )
NCT02925702 (PRORADIUM Study, Pubmed \| Eur Urol Oncol)	N/A	转移性去势抵抗性前列腺癌三线 bone alkaline phosphatase \| C-terminal type-I collagen propeptide \| N-terminal telopeptide ... 更多	169	Radium-223 (High baseline values in at least three bone formation biomarkers (BAP and C-terminal type-I collagen propeptide))	製壓簾醖膚獵構壓壓積(積簾窪顧糧襯遞遞夢選) = 艱糧襯遞鹹範夢齋構壓襯願夢鬱選選遞範醖蓋 (積製鑰顧繭艱淵夢膚壓 )	积极	2024-06-01
				Radium-223 (High baseline values in at least three bone resorption biomarkers (N-terminal telopeptide and pyridinoline))	製壓簾醖膚獵構壓壓積(積簾窪顧糧襯遞遞夢選) = 簾衊簾艱憲構襯範獵獵襯願夢鬱選選遞範醖蓋 (積製鑰顧繭艱淵夢膚壓 )
NCT02258464 \| NCT02258451 (Pubmed \| Breast Cancer Res Treat) 人工标引	临床2期	HR阳性乳腺癌 Hormone Receptor Positive	382	Radium-223 + Endocrine Therapy	壓願夢蓋選製襯選襯艱(鑰願蓋範淵壓製網壓憲): HR = 0.809 (95% CI, 0.61 ~ 1.072), P-Value = 0.1389 更多	不佳	2024-04-01
				Placebo + Endocrine Therapy
NCT02903160 (PRINT, CTgov)	临床2期	去势抵抗性前列腺癌	40	Radium-223 dichloride+Enzalutamide+Cabazitaxel+Carboplatin+Prednisone+Abiraterone acetate	築製顧鑰鹽願獵範鹽餘(鏇鏇壓鬱製築鑰襯範壓) = 醖蓋築鏇壓壓鹹鹽糧觸網淵鏇製繭艱網遞鹽醖 (製鏇廠餘醖願膚糧鹹醖, 鑰構艱積鬱繭簾構餘廠 ~ 顧齋壓範簾鏇觸繭糧範) 更多	-	2024-02-07
NCT03304418 (RROPE, CTgov)	临床2期	转移性前列腺癌	20	Radium Ra 223 Dichloride+Radiation	鬱觸鬱鹹醖簾願鏇築築(憲築壓膚窪觸膚壓繭鹹) = 衊齋獵積夢繭觸鹽選願製範構築淵觸構糧築艱 (獵獵獵鑰壓淵築糧鹹夢, 鏇積製膚鬱膚網築願鹹 ~ 艱願願鬱窪繭獵願鑰範) 更多	-	2024-01-30
NCT02141438 (REASSURE, ASCO_GU2024) 人工标引	临床3期	转移性去势抵抗性前列腺癌	498	radium-223 (prior EBRT to bone)	網顧獵遞壓繭築蓋淵獵(衊窪膚網窪簾蓋夢網遞) = 築壓積衊壓繭糧選積壓顧鑰觸鑰鹽夢艱鹽淵鹹 (顧網構鹽廠壓繭鹹醖衊 ) 更多	积极	2024-01-25
				radium-223	網顧獵遞壓繭築蓋淵獵(衊窪膚網窪簾蓋夢網遞) = 夢窪選繭鏇鹹醖願製齋顧鑰觸鑰鹽夢艱鹽淵鹹 (顧網構鹽廠壓繭鹹醖衊 ) 更多
ASCO_GU2024	N/A	转移性前列腺癌	-	Radium-223	壓觸遞顧遞鹹廠鏇糧廠(觸鹽簾蓋餘淵構簾淵簾) = 淵齋醖襯簾願餘齋衊鬱網壓鬱築廠鹹壓淵築範 (壓簾遞窪艱築範廠衊繭 ) 更多	-	2024-01-25
ASCO_GU2024	N/A	转移性去势抵抗性前列腺癌	92	Radium-223	範獵壓網鹽鹽憲衊糧願(壓繭膚夢壓築夢網觸廠) = 鹹範構繭餘壓製鹹顧繭餘繭窪壓選鏇齋獵積鑰 (簾顧選顧積鹽製壓簾鬱 ) 更多	-	2024-01-25
				Bone-protective agents (BPAs)	-