This clinical trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with liver cancer that has spread to other places in the body (metastatic). Yttrium Y-90 radioembolization is a therapy that injects radioactive microspheres directly into an artery that feeds liver tumors to cut off their blood supply. Performing yttrium Y-90 radioembolization in a single session may make treatment faster, minimize patient travel, and decrease the overall cost of the procedure.

开始日期2017-01-09

申办/合作机构

The University of Texas MD Anderson Cancer Center

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100 项与钇[90Y]树脂微球相关的临床结果

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100 项与钇[90Y]树脂微球相关的转化医学

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100 项与钇[90Y]树脂微球相关的专利（医药）

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项与钇[90Y]树脂微球相关的文献（医药）

2024-09-01·Health physics

Feasibility of Liver Transplantation after 90Y Radioembolization: Lessons from a Radiation Protection Incident

Article

作者: Lussey-Lepoutre, Charlotte ; Savier, Eric ; Allaire, Manon ; Roux, Charles ; Maisonobe, Jacques-Antoine ; Maksud, Philippe ; Soret, Marine ; Kas, Aurélie ; Payen, Stéphane

Abstract:

Radioembolization using 90Y is a growing procedure in nuclear medicine for treating hepatocellular carcinoma. Current guidelines suggest postponing liver transplantation or surgical resection for a period of 14 to 30 d after radioembolization to minimize surgeons’ exposure to ionizing radiation. In light of a radiation protection incident, we reevaluated the minimum delay required between radioembolization and subsequent liver transplantation. A patient with a hepatocellular carcinoma underwent a liver transplantation 44 h after undergoing radioembolization using 90Y (860 MBq SIR-Spheres). No specific radioprotection measures were followed during surgery and pathological analysis. We subsequently (1) evaluated the healthcare professionals' exposure to ionizing radiation by conducting dose rate measurements from removed liver tissue and (2) extrapolated the recommended interval to be observed between radioembolization and surgery/transplantation to ensure compliance with the radiation dose limits for worker safety. The surgeons involved in the transplantation procedure experienced the highest radiation exposure, with whole-body doses of 2.4 mSv and extremity doses of 24 mSv. The recommended delay between radioembolization and liver transplantation was 8 d when using SIR-Spheres and 15 d when injecting TheraSphere. This delay can be reduced further when considering the specific 90Y activity administered during radioembolization. This dosimetric study suggests the feasibility of shortening the delay for liver transplantation/surgery after radioembolization from the 8th or 15th day after using SIR-Spheres or TheraSphere, respectively. This delay can be decreased further when adjusted to the administrated activity while upholding radiation protection standards for healthcare professionals.

2024-05-01·European journal of nuclear medicine and molecular imaging

MIDOS: a novel stochastic model towards a treatment planning system for microsphere dosimetry in liver tumors

Article

作者: Dawson, Robert J ; Paganetti, Harald ; Wehrenberg-Klee, Eric ; Bolch, Wesley E ; Bertolet, Alejandro ; Beekman, Chris ; Withrow, Julia D ; Huesa-Berral, Carlos

PURPOSE:

Transarterial radioembolization (TARE) procedures treat liver tumors by injecting radioactive microspheres into the hepatic artery. Currently, there is a critical need to optimize TARE towards a personalized dosimetry approach. To this aim, we present a novel microsphere dosimetry (MIDOS) stochastic model to estimate the activity delivered to the tumor(s), normal liver, and lung.

METHODS:

MIDOS incorporates adult male/female liver computational phantoms with the hepatic arterial, hepatic portal venous, and hepatic venous vascular trees. Tumors can be placed in both models at user discretion. The perfusion of microspheres follows cluster patterns, and a Markov chain approach was applied to microsphere navigation, with the terminal location of microspheres determined to be in either normal hepatic parenchyma, hepatic tumor, or lung. A tumor uptake model was implemented to determine if microspheres get lodged in the tumor, and a probability was included in determining the shunt of microspheres to the lung. A sensitivity analysis of the model parameters was performed, and radiation segmentectomy/lobectomy procedures were simulated over a wide range of activity perfused. Then, the impact of using different microspheres, i.e., SIR-Sphere®, TheraSphere®, and QuiremSphere®, on the tumor-to-normal ratio (TNR), lung shunt fraction (LSF), and mean absorbed dose was analyzed.

RESULTS:

Highly vascularized tumors translated into increased TNR. Treatment results (TNR and LSF) were significantly more variable for microspheres with high particle load. In our scenarios with 1.5 GBq perfusion, TNR was maximum for TheraSphere® at calibration time in segmentectomy/lobar technique, for SIR-Sphere® at 1-3 days post-calibration, and regarding QuiremSphere® at 3 days post-calibration.

CONCLUSION:

This novel approach is a decisive step towards developing a personalized dosimetry framework for TARE. MIDOS assists in making clinical decisions in TARE treatment planning by assessing various delivery parameters and simulating different tumor uptakes. MIDOS offers evaluation of treatment outcomes, such as TNR and LSF, and quantitative scenario-specific decisions.

2024-03-01·Cardiovascular and interventional radiology

Transarterial Chemoembolization with Epirubicin-Loaded Microspheres for Hepatocellular Carcinoma: A Prospective, Single-Arm, Multicenter, Phase 2 Study (STOPPER Trial)

Article

作者: Li, Xiao ; Teng, Gao-Jun ; Li, Hai-Liang ; Lu, Jian ; Zhu, Xu ; Zhu, Hai-Dong ; Liu, Zhao-Yu ; Li, Rui ; Zhong, Bin-Yan ; Zhang, Qi ; Shao, Guo-Liang ; Yan, Zhi-Ping ; Chao, Min ; He, Xiao-Feng ; Lu, Li-Gong ; Sun, Jun-Hui

Abstract:

Purpose:

While the role of drug-eluting beads transarterial chemoembolization (DEB-TACE) for hepatocellular carcinoma (HCC) is established, questions regarding appropriate bead size for use in patients remain. This trial evaluated the effectiveness and safety of DEB-TACE using small-size (≤ 100 μm) microspheres loaded with epirubicin.

Materials and Methods:

This prospective, single-arm, multicenter study enrolled patients diagnosed with HCC who underwent DEB-TACE using 40 (range, 30–50), 75 (range, 60–90), or 100 (range, 75–125) μm epirubicin-loaded microspheres (TANDEM microspheres, Varian Medical). Bead size was at the discretion of treating physicians and based on tumor size and/or vascular structure. The primary outcome measure was 6-month objective response rate (ORR). Secondary outcome measures were 30-day and 3-month ORR, time to tumor progression and extrahepatic spread, proportion of progression-free survival and overall survival (OS) at one year, and incidence of treatment-associated adverse events.

Results:

Data from 108 patients from ten centers was analyzed. Six-month ORR was 73.3 and 71.3% based on European association for the study of the liver (EASL) and modified response evaluation criteria in solid tumors (mRECIST) criteria, respectively. Thirty-day ORR was 79.6% for both EASL and mRECIST criteria with 3-month ORR being 80.0 and 81.0%, respectively, for each criteria. One-year PPF and OS rate were 60.3 and 94.3%. There was a total of 30 SAEs reported to be likely to definitely associated with microsphere (n = 9), epirubicin (n = 9), or procedure (n = 12) with none resulting in death.

Conclusion:

DEB-TACE using epirubicin-loaded small-sized (≤ 100 μm) microspheres demonstrates promising local tumor control and acceptable safety in patients with HCC.

Trial Registration:

Clinicaltrials.gov NCT03113955; registered April 14, 2017.Trial Registration Clinicaltrials.gov NCT03113955; registered April 14, 2017.

Level of evidence:

2, Prospective, Non-randomized, Single-arm, study.

Graphical Abstract:

项与钇[90Y]树脂微球相关的新闻（医药）

2024-10-14

·远大医药官微

远大医药全球创新放射性核素偶联药物ITM-11国内III期临床试验申请获药监局受理

本次ITM-11获受理的COMPETE桥接研究有望进一步扩大该产品的适用人群，有望实现该产品对于胃肠胰腺神经内分泌瘤各阶段病程的全方位覆盖； ITM-11使用的无载体的177Lu拥有更高的比活度和纯度，且放射污染小，产品已在美国和欧洲获得孤儿药资格认定，且其可与公司TOCscan®形成产品组合，实现对GEP-NETs的诊疗一体化；目前，远大医药是进入中国III期临床研究中诊断和治疗类RDC创新药总计储备最多的企业，也是全球范围内在核药抗肿瘤领域拥有最丰富产品管线和诊疗一体化布局的创新药企之一。近日，远大医药(0512.HK)用于治疗胃肠胰腺神经内分泌瘤的全球创新放射性核素偶联药物(RDC) ITM-11的一项III期临床研究（COMPETE桥接研究）的申请已获得国家药监局的正式受理。关于COMPETE桥接研究 COMPETE桥接研究是一项前瞻性、随机、对照、开放性、多中心III期临床研究，拟在中国入组超过60例患者，旨在评估ITM-11多肽受体放射性核素治疗（PRRT）对比标准治疗，在不可手术、进展性、高分化1级或2级、生长抑素受体阳性（SSTR+）的胃肠或胰腺神经内分泌瘤（GEP-NETs）患者中的有效性和安全性。此前公司已于今年三月获得药监局批准开展ITM-11针对高分化侵袭性2级和3级GEP-NETs的III期临床研究（COMPOSE研究），目前该临床研究正在顺利推进中。此次COMPETE 桥接研究将有望进一步扩大ITM-11产品的适用人群，有望实现该产品对于胃肠胰腺神经内分泌瘤各阶段病程的全方位覆盖。关于ITM-11 ITM-11是一款基于放射性核素偶联技术靶向杀伤治疗GEP-NETs的RDC药物，该产品是将无载体177Lu与生长抑素类似物偶联，通过与GEP-NETs表面高水平表达的生长抑素受体(SSTR)结合靶向杀伤肿瘤细胞。与目前常用的有载体177Lu核素产品相比，无载体的177Lu拥有更高的比活度和纯度，而且生产过程中产生的长半衰期杂质少，放射性废物更易于处理。该产品已经获得美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)等机构的孤儿药资格。关于胃肠胰腺神经内分泌瘤根据Frost & Sullivan的数据，2020年，中国胃肠胰腺神经内分泌瘤的新发确诊病例为71,300例，发病率逐年上升。《CSCO神经内分泌肿瘤诊疗指南2021》中提示，基于177Lu的肽受体放射性核素治疗在无进展生存时间(PFS)和客观缓解率(ORR)等指标方面优于目前临床一线使用的高剂量奥曲肽（生长抑素类似物），可带来明显的患者获益。 ITM-11可与公司另一款用于诊断GEP-NETs的RDC产品TOCscan®形成产品组合，实现对GEP-NETs的诊疗一体化，有望为中国GEP-NETs患者提供全新的诊疗方案。持续推进创新产品研发夯实全球核药领军地位核药抗肿瘤诊疗板块是远大医药的重点布局的领域之一。围绕肿瘤诊疗一体化的治疗理念，公司核药抗肿瘤诊疗板块目前已储备12款创新产品，涵盖68Ga、177Lu、131I、90Y、89Zr在内的5种放射性核素，覆盖了肝癌、前列腺癌、脑癌等在内的7个癌种；在产品种类方面，涵盖诊断和治疗两类核素药物，为患者提供多适应症治疗选择、多手段且诊疗一体化的全球领先的抗肿瘤方案。目前，远大医药在核药抗肿瘤诊疗板已有4款 RDC创新药获批开展临床研究，其中3款已进入III期临床阶段，包括诊断前列腺癌的产品TLX591-CDx、诊断透明细胞肾细胞癌产品TLX250-CDx，以及治疗GEP-NETs的产品ITM-11。截至目前，公司是进入中国III期临床研究中诊断和治疗类RDC创新药总计储备最多的企业，也是全球范围内在核药抗肿瘤领域拥有最丰富产品管线和诊疗一体化布局的创新药企之一。关于远大医药核药抗肿瘤诊疗平台核药抗肿瘤诊疗平台是公司在抗肿瘤领域重点打造的高端技术平台，目前公司已实现了研发、生产、销售、监管资质等多个环节的全方位布局，建立了完整的产业链。远大医药联合Sirtex Medical Pty Limited并与Telix Pharmaceutical Limited (ASX: TLX)和ITM Isotope Technologies Munich SE合作，搭建了具有国际化一流水平的肿瘤介入研发平台和RDC药物研发平台，已拥有近650名员工，是远大医药全球化程度最高的板块之一。同时，公司与山东大学联合成立了远大医药-山东大学放射药物研究院，并以该研究院为核心建立了核药早期研发平台，进行RDC药物的自主研发。目前早期研发阶段的产品储备已达12款。远大医药正在有序推进甲级资质核素生产平台的建设。未来，公司将持续加强核药抗肿瘤诊疗板块的研发和建设，丰富和完善产品管线及产业布局，形成以易甘泰®钇[90Y]微球注射液为核心的核药抗肿瘤诊疗产品集群，持续夯实远大医药在全球核药抗肿瘤诊疗领域领军企业地位。远大医药集团有限公司董事会表示：“本集团一直高度重视创新产品和先进技术的研发，未来将持续加大对全球创新产品和先进技术的投入，丰富和完善产品管线及产业布局，坚持‘全球化运营布局，双循环经营发展’策略，充分发挥本集团的产业优势和研发实力，快速将科技创新产品落地上市，为全球患者提供更先进更多样的治疗方案。” 大家都在看 ▲希望照进现实：中晚期肝癌患者求生记 ▲ 砥砺三载共赴山海 | 数说钇90这三年 ▲世界清洁日 | 远大医药：绿色先行健康守护 ↑↓ 上下滑动了解更多 ➤关于远大医药远大医药是一家科技创新型国际化医药企业，核心业务横跨制药科技、核药抗肿瘤诊疗及心脑血管精准介入诊疗科技、生物科技三大领域。公司以医药及生物工业为基础，以患者需求为核心，以科技创新为源动力，针对尚未满足的临床需求，加大对全球创新产品和先进技术的投入，丰富和完善产品管线，巩固和强化产业链布局，充分发挥产业优势和研发实力，为全球患者提供更先进更多样的治疗方案。「稳增长、强创新、谋布局」，远大医药将继续秉承「综合优势、创新引领和全球拓展」的发展理念，采用「自主研发和全球拓展双轮驱动，全球化运营布局和双循环经营发展」策略，形成国内国外双循环联动发展并相互促进的新格局，致力于成为一家受医生和患者尊重并还原于社会的科技创新型国际化医药企业。 ➤前瞻性声明本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本集团有关的，均属于前瞻性表述。本集团并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本集团管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险不确性及其他因素的影响，有些是超出本集团的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本集团、本集团董事及雇员代理概不承担(1)更正或更新本网站所载前瞻性表述的任何义务;及(2)若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

孤儿药临床3期CSCO会议上市批准

2024-09-27

·药渡

【药渡药闻报告-仿制药篇】-2024年36期/总第97期

国内仿制药研发批准动态 01 新注册分类品种首家批准上市情况根据药渡数据调研，本次统计周期（2024.09.14-09.20）新增4个新注册分类首家过评受理号，涉及2个品种，包含1个片剂，1个注射剂。与上次统计周期相比，本次减少3个新注册分类首家过评品种。新注册分类首家过评情况艾塞那肽注射液艾塞那肽最早是由Amylin制药开发，为全球首个GLP-1类似物，与礼来联合商业化推广；Amylin制药后被BMS收购，与阿斯利康共同开发市场。 2005年4月，艾塞那肽获FDA批准上市，商品名为百泌达（Byetta），上市后即被国际糖尿病专家列为四大潜力药物之首。2009年，艾塞那肽进入中国市场，成为首款进入中国市场的GLP-1受体激动剂。根据药渡数据调研，目前全球市场在售的艾塞那肽包括注射液和注射用微球两种剂型。微球剂型由于较高的技术壁垒，目前国内尚无企业获得生产批文。目前国内市场销售的主力剂型是艾塞那肽注射液。药渡数据-仿制药库调研信息显示，包括原研企业礼来和阿斯利康在内，国内共有4家企业拥有艾塞那肽注射液的生产批文，涉及企业有青海晨菲制药以及此次视同过评的翰宇制药，翰宇制药成功拿下该品种“首仿”。篇幅原因，仅展示前五家企业申报进展情况，更多信息，请查看药渡数据-仿制药库根据药渡数据-中国注册库信息显示，目前国内共有2家企业进行艾塞那肽注射液的新4类报产申请，其中成都圣诺生物制药首发折戟，于去年11月收到NMPA药品通知件，上市失败，今年8月成都圣诺生物制药再次报产，目前正在审评审批过程中。翰宇制药后来者居上，于本周一举拿下艾塞那肽注射液的“首仿”称号。艾塞那肽注射液新注册分类申报受理情况作为全球第一个获批上市的GLP-1药物，艾塞那肽注射液上市后销售额接连上涨。随着后续更多的GLP-1药物获批，2009年后艾塞那肽产生销售断崖。后续推出了艾塞那肽微球缓释制剂，销售额略有上升。在国内市场中，双胍类、磺脲类和AGI类等已上市几十年的传统口服药物在中国仍为主流，这些新型药物由于进入中国市场的时间较晚，带来的销售收入比例远不及全球其他发达国家。根据药渡数据-中国销量库调研，艾塞那肽注射液国内销售情况不是很理想，2023年度销售额达到1966万元，阿斯利康占据了99%以上的市场份额。随着新药物的可及性提高且控糖需求的不断扩大，相信未来艾塞那肽注射液销售仍有提振的空间。此次翰宇制药拿下“首仿”，未来必将撼动原研一家独大的市场格局，为国内患者带来更实惠的治疗选择。 02 一致性评价品种首家批准上市情况根据药渡数据调研，本次统计周期（2024.09.14-09.20）无新增一致性评价首家过评受理号。与上次统计周期相比，本次减少1个一致性评价首家过评品种。 03 新注册分类品种批准上市情况根据药渡数据调研，本次统计周期（2024.09.14-09.20）新注册分类新增39个过评受理号，涉及34个品种，包括8个注射剂，15个片剂，2个胶囊剂，1个喷雾剂，4个滴眼剂，1个吸入制剂，1个吸入溶液剂，1个口服溶液剂，1个滴剂。与上次统计周期相比，本次减少17个新注册分类过评品种。新注册分类品种过评情况（部分） 04 一致性评价品种批准上市情况根据药渡数据调研，本次统计周期（2024.09.14-09.20）无新增一致性评价过评受理号。与上次统计周期相比，本次减少4个一致性评价过评品种。 05 仿制药品种批准临床情况 06 仿制药品种拒绝批准/主动撤回情况国内仿制药研发申报动态 01 新注册分类品种申报上市情况根据药渡数据调研，本次统计周期（2024.09.14-09.20）新注册分类数据新增93个新报受理号，涉及71个品种，包括26个片剂，25个注射剂，4个吸入溶液剂，5个口服溶液剂，1个气雾剂，4个滴眼剂，1个滴剂，1个乳胶剂，1个凝胶贴膏，1个灌肠剂，1个搽剂，1个吸入混悬液。与上次统计周期相比，本次减少36个新注册分类申报品种。新注册分类品种申报受理情况（部分） 02 一致性评价品种申报上市情况根据药渡数据调研，本次统计周期（2024.09.14-09.20）一致性评价数据新增5个新报受理号，涉及3个品种，包括2个注射剂，1个胶囊剂。与上次统计周期相比，本次减少8个一致性评价申报品种。一致性评价申报受理情况 03 仿制药补充申请情况 04 仿制药申报上市专利声明信息汇总国内仿制药研发领域热点聚焦 01 国内仿制药研发领域政策法规相关动态国家药监局关于蜂胶口腔膜转换为乙类非处方药并修订药品说明书的公告（2024年第114号）为保障公众用药的可及性，指导公众合理用药，经国家药品监督管理局组织论证和审核，将蜂胶口腔膜由甲类非处方药转换为乙类非处方药，并对非处方药说明书进行修订。现将有关事项公告如下：请相关药品上市许可持有人于2025年6月11日前，依据《药品注册管理办法》（国家市场监督管理总局令第27号）等有关规定，就修订说明书事项向省级药品监督管理部门备案，并将说明书修订的内容及时通知相关医疗机构、药品经营企业等单位。非处方药说明书范本规定内容之外的说明书其他内容按原批准证明文件执行。药品标签涉及相关内容的，应当一并修订。自补充申请备案之日起生产的药品，不得继续使用原药品说明书。特此公告。 02 国内仿制药研发领域热点新闻人福医药：人福医药关于烟酸缓释片获得药品注册证书的公告 9月19日，人福医药集团股份公司发布公告称，控股子公司宜昌人福药业有限责任公司近日收到国家药品监督管理局核准签发的烟酸缓释片的《药品注册证书》。现将批件主要内容公告如下：一、药品名称：烟酸缓释片二、批件号：2024S02168、2024S02169、2024S02170 三、剂型：片剂四、规格：0.5g、0.75g、1.0g 五、注册分类：化学药品3类六、申请事项：药品注册（境内生产）七、药品批准文号：国药准字H20244859、国药准字H20244860、国药准字H20244861 八、药品批准文号有效期：至2029年09月09日九、上市许可持有人：宜昌人福药业有限责任公司十、药品生产企业：宜昌人福药业有限责任公司十一、审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求，批准注册，发给药品注册证书。质量标准、说明书、标签及生产工艺照所附执行。药品生产企业应当符合药品生产质量管理规范要求方可生产销售。本次获批的烟酸缓释片适用于原发性高胆固醇血症和混合型血脂异常的成人患者，以降低低密度脂蛋白胆固醇（LDL-C）、总胆固醇（TC）、载脂蛋白B（ApoB）和甘油三酯（TG）水平，同时可升高高密度脂蛋白胆固醇（HDL-C）水平。宜昌人福的烟酸缓释片为中美共线品种，宜昌人福于2019年6月获得美国FDA批准的烟酸缓释片ANDA文号。2021年7月宜昌人福向国家药品监督管理局提交了烟酸缓释片的上市许可申请并获得受理，截至目前该项目累计研发投入约为人民币1,000万元。根据米内网数据显示，2023年烟酸缓释片在我国城市、县级终端公立医院及城市药店的销售额约为人民币1,700万元，主要厂商为西南药业股份有限公司等。本次烟酸缓释片获批，标志着宜昌人福具备了在中国市场销售该药品的资格。该产品进一步丰富了公司的产品线，其上市销售将给公司带来积极影响。宜昌人福将根据市场需求情况，着手安排烟酸缓释片的生产上市。小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在“药渡仿制”公众号后台回复“0925仿制药周报”获取全文。

一致性评价上市批准并购

2024-09-16

·PRNewswire

Sirtex Medical Announces Certification of SIR-Spheres® Y-90 Resin Microspheres According to Medical Device Regulation (EU) 2017/745 and European Launch of the Innovative SIROS™ Delivery System

Sirtex brings an innovative liver cancer treatment delivery system to Europe, enhancing options for physicians and their patients. WOBURN, Mass., Sept. 16, 2024 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional treatment solutions, today announced that it has received certification according to Medical Device Regulation (EU) 2017/745 for SIR-Spheres® Y-90 resin microspheres and its delivery systems, paving the way for the European launch of the SIROS™ Delivery System. The EU MDR places greater emphasis on patient safety measures, risk management, post-market surveillance, and comprehensive data collection for medical devices seeking European market access. "Patient health and safety are always at the forefront of our work. That is why we are particularly proud to receive EU MDR certification for SIR-Spheres® Y-90 resin microspheres and its delivery systems, including SIROS™. This achievement underscores our commitment to delivering innovative products responsibly and ethically," said Matt Schmidt, CEO of Sirtex Medical Inc. "With the expansion of SIROS™ outside of the U.S., interventional radiologists in Europe now have an additional option to support patients battling metastatic colorectal cancer (mCRC) and unresectable hepatocellular carcinoma (HCC). This milestone reflects the outstanding efforts of our team, the rapid growth of our business, and the groundbreaking interventional oncology solutions we have developed." The SIROS™ Delivery System offers an intuitive, visual, and adaptable solution for physicians to administer SIR-Spheres® to liver cancer patients. Its easy-to-use design along with controlled administration provides physicians confidence in the Y-90 delivery. "As an interventional radiologist, I am excited about the future use of the SIROS™ Delivery System," shared Professor Thomas Helmberger, Head of Department of Radiology, Neuroradiology, and Minimal-Invasive Therapy at München Klinik Bogenhausen in Munich, Germany. "This device has an intuitive design and a precise control that will facilitate the administration of SIR-Spheres® Y-90 resin microspheres, and I am looking forward to incorporating it into my practice." About SIR-Spheres® in Europe SIR-Spheres® are medical devices used in selective internal radiation therapy (SIRT) and are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients refractory to or intolerant of chemotherapy. For a complete listing of indications, contraindications, side effects, warnings, and precautions, please consult the Instructions for Use at . About Sirtex Sirtex is a global healthcare company with offices in the U.S., Australia, Europe, and Asia, dedicated to improving patients' quality of life and longevity through innovative, minimally invasive cancer and embolization therapies. Sirtex's current leading product, SIR-Spheres® Y-90 resin microspheres, offers targeted radiation therapy for liver cancer. For more information, visit . SOURCE Sirtex Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

放射疗法

100 项与钇[90Y]树脂微球相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肝癌	中国	远大医药（中国）有限公司	2022-06-19
肝细胞癌	德国	Sirtex Medical Pty Ltd.	2022-03-22
结直肠癌	美国	Sirtex Medical Pty Ltd.	2002-05-03
肝转移	美国	Sirtex Medical Pty Ltd.	2002-05-03

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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


ASCO2008	N/A	肝转移	34	Radioactive microspheres (Yttrium-90 resin microspheres)	廠範襯膚夢夢鏇繭獵廠(襯廠積鑰蓋壓夢餘簾築) = mild to severe 餘鑰簾衊選製鑰鏇選製 (膚襯鹹淵淵顧窪鹽簾窪 )	-	2008-05-20
ASCO2004	N/A	不可切除的肝细胞癌	80	90Yttrium microspheres (Therasphere)	鏇齋醖網壓築衊淵獵襯(齋鏇製鹽夢鹽窪窪觸選) = 壓鬱襯製顧積範範膚獵糧範觸淵齋窪膚鹽廠餘 (築積獵鬱鬱範構鑰艱鹹 ) 更多	-	2004-07-15