Single-arm Open-label Phase II Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed)

Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)

开始日期2024-10-01

申办/合作机构-

NCT05687123 / Recruiting临床1期IIT

A Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine Tumors

This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.

开始日期2024-08-14

申办/合作机构

National Cancer Institute

NCT05987176 / Recruiting临床2期IIT

An International Multicentre Randomized Unblinded Phase II Study Comparing Adjuvant Treatment With 177Lu-DOTATATE (Lutathera®) to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases

An international multi-centre, open, randomised, parallel-group phase II study comparing adjuvant treatment with 177Lu-DOTATATE to best supportive care in patients after complete surgical removal of neuroendocrine liver metastases.
In this study, adjuvant treatment with 177Lu-DOTATATE will be compared with best supportive care in patients with well differentiated grade 1 or 2 neuroendocrine tumours in the stomach, pancreas or gut (gastro-entero-pancreatic NETs) who had their primary tumour already removed or in whom both primary and liver tumour metastases removal will take place simultaneously, including removal of perihilar lymph nodes will be eligible.
The primary objective is to compare overall disease-free survival at 3 years after treatment with 177Lu-DOTATATE to best supportive care between both treatment arms, with equal chances of entering either arm (1:1)
Secondary objectives are to describe and compare the difference in disease-free survival in the liver, overall survival, time to the next anticancer treatment, the cost effectiveness and health-related quality of life. The safety and toxicity of 177Lu-DOTATATE as adjuvant therapy will also be described.
Additionally, the clinical use of blood and urine analysis test (NETest) will be evaluated to identify microscopic remaining disease and detect early the return of the tumour.

开始日期2024-08-02

申办/合作机构

Imperial College London

100 项与 (177镥)镥氧奥曲肽相关的临床结果

登录后查看更多信息

100 项与 (177镥)镥氧奥曲肽相关的转化医学

登录后查看更多信息

100 项与 (177镥)镥氧奥曲肽相关的专利（医药）

登录后查看更多信息

1,100

项与 (177镥)镥氧奥曲肽相关的文献（医药）

2024-12-01·Nuclear Medicine Communications

SeHCAT retention measurements may be compromised by traces of 177Lu/177mLu more than 90 days after 177Lu-DOTATATE was administered

Article

作者: Meades, Richard ; Willson, Tamar

[75Se]tauroselcholic acid (SeHCAT) retention measurement provides a noninvasive test for bile acid diarrhea (BAD); however, it is sensitive to the presence of other radionuclides. Two SeHCAT patients at the Royal Free Hospital (RFH) had significant discrepancies between the lower photopeak (111–159 keV) and central photopeak (242–296 keV) windows, indicating contamination with a radionuclide other than 75Selenium. These patients had received lutetium-177 oxodotreotide (177Lu-DOTATATE) therapy 98 and 151 days before their SeHCAT tests. Traces of 177Lu may be retained longer than typically modeled, along with the contaminant 177mLu. This work includes a retrospective audit to examine the prevalence of SeHCAT tests being affected by 177Lu and phantom measurements to investigate the potential impact. Of 579 patients who received 177Lu-DOTATATE therapy at our center, 11 subsequently attended for a SeHCAT test. The two previously identified patients may have had compromised SeHCAT results; however, the other patients had longer intervals between their therapy and test, and their tests are believed to be valid. Spectra were acquired from a phantom containing either a SeHCAT capsule or a mixture of 177Lu/177mLu representative of a patient >90 days after their treatment. The SeHCAT spectrum was scaled to produce simulated day-7 spectra, and the SeHCAT retention that would have been calculated if 177Lu/177mLu were present was determined. All SeHCAT measurement windows are affected by the 177Lu/177mLu, producing clinically significant errors. Patients requiring SeHCAT testing should be asked whether they have ever received 177Lu-DOTATATE. Patient-specific background measurements may be useful for checking for significant levels of other radionuclides.

2024-12-01·Applied Radiation and Isotopes

The production and separation of 161Tb with high specific activity at the University of Utah

Article

作者: Holiski, Connor K. ; Wang, Meng-Jen (Vince) ; Bender, Aidan A. ; Bender, Aidan A ; Monte, Peñafrancia F ; Monte, Peñafrancia F. ; Holiski, Connor K ; Embree, Mary F ; Sjoden, Glenn E ; Hennkens, Heather M ; Hennkens, Heather M. ; Sjoden, Glenn E. ; Wang, Meng-Jen Vince ; Mastren, Tara ; Embree, Mary F.

Targeted radiotherapy (TRT) is an increasingly prominent area of research in nuclear medicine, particularly in the context of treating cancerous tumors. One radionuclide of considerable interest for TRT is terbium-161 (t_1/2 = 6.95 days), which undergoes beta emission and shares similar decay properties as ¹⁷⁷Lu (FDA-approved as LUTATHERA® and PLUVICTO®). Besides beta emission, ¹⁶¹Tb also emits a significant number of conversion and Auger electrons further enhancing its therapeutic potential. Terbium-161 can be produced using nuclear reactors through an indirect neutron capture reaction, G64160dn,γG64161d→3.66min,β^-T65161b, from ¹⁶⁰Gd targets. However, a key challenge in utilizing ¹⁶¹Tb for TRT lies in effectively separating target and product materials to attain high specific activity for radiolabeling. Here, we detail the production of no-carrier added ¹⁶¹Tb using low flux research reactors (mean thermal (<0.625 eV) neutron flux: 1.356×10¹²n∙cm^-2∙s^-1) like the University of Utah TRIGA Reactor, using enriched ¹⁶⁰Gd₂O₃ targets (1.5 ± 0.3 μCi of ¹⁶¹Tb per mg of ¹⁶⁰Gd target per hour of irradiation). We also developed a separation technique based on cation exchange and extraction chromatography, suitable for mCi level irradiations with targets exceeding 200 mg. In a simulated full-scale irradiation, ¹⁶¹Tb was successfully isolated from large mass targets using cation exchange (AG 50W-X8, with 2-hydroxyisobutyric acid at 70 mM, pH 4.75) and extraction chromatography (LN Resin, 0.5-0.75 M HNO₃) methods. This resulted in high apparent molar activities of [¹⁶¹Tb]Tb-DOTA (113 ± 3 MBq/nmol), demonstrating high purity ¹⁶¹Tb relevant for potential future preclinical applications.

2024-11-01·Journal of Nuclear Medicine

Cardiac Neuroendocrine Tumor Metastases on⁶⁸Ga-DOTATATE PET/CT: Identification and Prognostic Significance

Article

作者: Patel, Vandan ; Alhamshari, Ahmad S ; Bhattaru, Abhijit ; Vidula, Mahesh K ; Lee, Hwan ; Bravo, Paco E. ; Pryma, Daniel A ; Vidula, Mahesh K. ; Bravo, Paco E ; Pryma, Daniel A. ; Rojulpote, Chaitanya ; Alhamshari, Ahmad S.

Neuroendocrine tumor (NET) metastases to the heart are found in 1%-4% of NET patients and have been reported primarily in the form of individual cases. We investigated the prevalence, clinical characteristics, imaging features, and outcomes of NET patients with cardiac metastases on ⁶⁸Ga-DOTATATE PET/CT. Methods: ⁶⁸Ga-DOTATATE PET/CT of 490 consecutive patients from a single institution were retrospectively reviewed for sites of metastases. The cumulative cardiovascular event rate and overall survival of patients with cardiac NET metastases (CNMs) were compared with those of a control group of metastatic NET patients without cardiac metastases. In patients with CNMs, the cardiac SUV_max with and without normalization to the myocardial background uptake was compared with a separate cohort of 11 patients with active cardiac sarcoidosis who underwent ⁶⁸Ga-DOTATATE PET/CT for research purposes. Results: In total, 270 patients with metastatic NETs were identified, 9 (3.3%) of whom had CNMs. All 9 patients had grade 1-2 gastroenteropancreatic NETs, most commonly from the small intestine (7 patients). The control group consisted of 140 patients with metastatic grade 1-2 gastroenteropancreatic NETs. On Kaplan-Meier analysis, there was no significant difference in the risk of cardiovascular adverse events (P = 0.91 on log-rank test) or mortality (P = 0.83) between the metastatic NET patients with and without cardiac metastases. The degree of cardiac DOTATATE uptake was significantly higher in CNMs than in patients with cardiac sarcoidosis without overlap, in terms of both cardiac SUV_max (P = 0.027) and SUV_max-to-myocardial background ratio (P = 0.021). Conclusion: Routine ⁶⁸Ga-DOTATATE PET/CT can be used to identify CNMs in 3% of patients with metastatic NETs. CNMs do not confer added cardiovascular or mortality risk. A distinguishing feature of CNMs is their high degree of DOTATATE uptake compared with focal myocardial inflammation.

415

项与 (177镥)镥氧奥曲肽相关的新闻（医药）

2024-11-19

·Pharmaceutical Technology

Novartis strengthens radiopharma leadership with Ratio Therapeutics deal

Radiopharmaceutical therapy involves targeting cancer cells with a radioactive drug. Credit: elenabsl via Shutterstock. Novartis is bolstering its leadership in the radiopharmaceutical space by partnering with US-based startup Ratio Therapeutics to develop a somatostatin receptor 2 (SSTR2) radiotherapeutic for cancer treatment. As part of the agreement, Ratio stands to receive up to $745m in combined upfront and milestone payments, along with tiered royalties on sales. The collaboration focuses on preclinical research to identify an SSTR2-targeting development candidate, after which Novartis will take the lead on development, manufacturing, and commercialisation. A protein overexpressed in various cancers, SSTR2 is a key target for therapies due to its role in enabling precise and targeted treatment. Novartis is already a key player in this field with its pioneering radiopharmaceutical Lutathera (lutetium Lu 177 dotatate), which also targets SSTR2. Acquired in the $3.9bn purchase of Advanced Accelerator Applications in 2017, Lutathera was the first radiopharmaceutical approved by the FDA and the EMA for treating neuroendocrine gastroenteropancreatic tumours. This latest partnership follows a surge of investment within the radiopharmaceutical space. In May, Novartis acquired Mariana Oncology in a $1.75bn deal, inheriting the latter’s lead candidate MC-339, a radioligand therapy (RLT) designed to target small-cell lung cancer. Meanwhile, other big pharma companies such as Bristol Myers Squibb (BMS) and Eli Lilly have also entered the arena, with acquisition deals worth $4.2bn and $1.4bn, respectively. Ratio brings innovation to the table through its proprietary Trillium and Macropa platforms, which use alpha particles’ tumour-killing properties to develop tuneable radiopharmaceuticals. These platforms aim to expand the range of solid tumours that can be targeted. Earlier this year, Ratio secured $50m in Series B funding to accelerate the platforms’ development. In the announcement accompanying the deal, Novartis’ president of biomedical research Fiona Marshall said: “Radioligand therapies hold transformative potential for certain forms of cancer, and Novartis is committed to maximising their impact by continually improving the benefit for patients.” Radiopharmaceutical therapy – which involves targeting cancer cells with a radioactive drug consisting of a radioactive atom combined with a cell-targeting molecule – has seen substantial growth in recent years. Venture financing for innovative radiopharmaceutical drugs witnessed an increase from $63m in 2017 to over $400m in 2023 total deal value in the US, according to GlobalData’s Pharma Intelligence Center Deals Database. GlobalData is the parent company of Pharmaceutical Technology.

上市批准并购放射疗法

2024-11-18

·医药魔方Pro

超7亿美元！诺华“加码”核药

11月18日，Ratio Therapeutics宣布与诺华子公司Novartis Pharma AG签订了全球独家许可和合作协议。Ratio致力于利用创新技术开发best-in-class放射性药物。此次合作主要聚焦下一代SSTR2靶向放射性药物。根据协议条款，Ratio将获得高达7.45亿美元的预付款和潜在里程碑付款，并有资格获得分级特许权使用费。Ratio将与诺华合作，推动临床前活动，以筛选靶向SSTR2的候选药物。诺华将负责所有剩余的开发、生产和商业化活动。 Ratio成立于2022年，总部位于波士顿。2024年1月，公司宣布完成5000万美元的B轮融，BMS也出现在投资者名单中。Ratio主打Trillium™和Macropa™两大技术平台。Trillium™用于调节候选分子的药代动力学（PK），提高药物可用性和肿瘤递送，同时降低副作用。Macropa™技术包含一种专有的螯合剂，其独特的化学性质使其易于制造，并提高了所得化合物的体内稳定性。Macropa™可与多种化合物一起使用，从小分子到多肽，甚至大多肽，如抗体。知识卡：靶向放射性药物（也被称为放射性配体疗法、RDC等）一般包含四部分：放射性同位素（radioisotope）、螯合剂（chelator，负责稳定或“笼化”放射性核素，以防止核素在到达目的地之前伤及无辜）、靶向配体（负责精准识别和结合肿瘤靶点）及连接子（linker，负责连接靶向配体和螯合剂）。 Ratio认为，结合Trillium™和Macropa™两大平台非常有可能开发出基于α粒子（actinium-225）的best-in-class放射性药物。目前公司在推进其首个FAP靶向放射性药物的开发，计划明年进入临床试验。而关于此次与诺华合作的靶点，医药魔方NextPharma®数据库显示，目前全球有20款左右SSTR2靶向放射性药物在研，进展最快的是BMS的RYZ101，处于III期临床。去年12月，BMS以41亿美元收购 RayzeBio获得了RYZ101等资产。诺华是核药赛道当之无愧的“王者”，目前手握Lutathera和Pluvicto两款明星产品，且有包括177Lu-FAP-2286、177Lu-NeoB、225Ac-PSMA-617在内的多款在研管线。2024年，诺华在核药赛道继续加码，5月以17.5亿美元收购了核药公司Mariana Oncology。参考资料： [1]https://ratiotx.com/2024/11/18/november-18th-2024-ratio-enters-license-and-collaboration-agreement-with-novartis-for-sstr2-targeting-radiotherapeutic-candidate/ [2]https://www.businesswire.com/news/home/20231225781528/en/%C2%A0Bristol-Myers-Squibb-Adds-Premier-Radiopharmaceutical-Platform-with-Acquisition-of-RayzeBio Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任

放射疗法临床3期引进/卖出并购临床结果

2024-11-17

·求实药社

全球核药冠军进军中国！前列腺癌治疗或将被改写

近年来，抗癌新疗法层出不穷。其中，核药疗法在肿瘤领域展现出巨大的治疗潜力。在核药领域，诺华是当之无愧的领军企业，而其重磅核药Pluvicto是核药赛道近几年的最火的产品。诺华最新的三季报显示，Pluvicto前三季度总营收已超10亿美元，是目前为止年销售额最高的放射性治疗药物。 11 月 13 日，诺华的放射性配体疗法Pluvicto（镥 [177Lu] 特昔维匹肽注射液）上市申请获 CDE 受理。此前该药已被 CDE 纳入优先审评，适用于治疗前列腺特异性膜抗原（PSMA）阳性转移性去势抵抗性前列腺癌（mCRPC) 、已接受雄激素受体通路抑制和紫杉类化疗的成年患者。该药是 FDA 批准的首个针对去势抵抗性前列腺癌患者的靶向放射性配体疗法，本次是在国内首次报上市。截图来源：CDE 官网全球首个10亿美元核药单品全球核药市场规模预计将从2019年的60亿美元提升至2030年的300亿美元左右。这一增长趋势，加上核药在精准医疗中的独特优势，使得核药成为了医药行业的新蓝海。放射性配体疗法是目前癌症治疗中一个极有前景的新领域。这些药物能够提供靶向放射疗法，特异性杀死癌细胞，而对健康组织的损害较小。以放射配体疗法为代表的核药是诺华重金布局的领域，而诺华的核药Pluvicto（镥 [177Lu] 特昔维匹肽）是这一领域的明星产品。镥 [177Lu] 特昔维匹肽是一款 PSMA 靶向放射性配体疗法，其将 PSMA-617 与发射β射线的 177Lu 连接在一起，与表达 PSMA 的前列腺癌细胞结合后，177Lu 释放的辐射能量会辐射并杀死肿瘤细胞。它于2022年3月在美获批，用于治疗PSMA阳性的转移性去势抵抗性前列腺癌（mCRPC）。2023年上半年，诺华RDC产品Pluvicto的商业供应告急，需求超出预期，导致美国多家医疗机构的患者剂量供应被推迟。业内预计，上述短缺原因正是出在供应上，由于需求量巨大，Pluvicto因同位素供应短缺导致产能不足，从而造成巨大的临床需求缺口；另外，该种药物保质期只有几天，无法提前储备，限制了Pluvicto的广泛应用。为了逐步解决生产供应问题，诺华在全球多个国家投资扩大产能，以集中生产模式为主，并通过联邦快递实现12小时内药品快速送达患者。在供应极度紧张的情况下，Pluvicto在2023年第一季度的销售额仍然达到了2.11亿美元，同比增长18%，超出华尔街11%的预期。同年二季度，Pluvicto继续放量，销售额为2.4亿美元。2023年，Pluvicto 以260%的增幅实现9.8亿美元销售收入，距离成为10亿美元“重磅炸弹”级别药物仅一步之遥。2024年，Pluvicto持续放量，上半年销售额6.55亿美元，同比增长45%。最新的三季报显示，Pluvicto前三季度总营收达10.41亿美元，成为全球首款销售额突破10亿美元的核药产品。华尔街对Pluvicto的销售峰值预测高达60亿美金，这无疑显示了市场对核药的巨大期待。引领核药赛道的王者早在2017年，诺华就以39亿美元的价格收购Advanced Accelerator Applications（AAA），获得了放射性配体药物Lutathera（177Lu-dotatate）和相关技术平台；次年，又斥资21亿美元收购Endocyte，获得Pluvicto（177Lu-PSMA-617）和255AC-PSMA-617的权益。这两起颇具前瞻性且眼光精准的收购让诺华在放射性配体疗法（Radioligand Therapy，RLT）赛道拥有了两款极具竞争力的药物——Lutathera和Pluvicto，两款药物的上市奠定了诺华在核药领域的领导者地位。 Lutathera (lutetium 177Lu dotatate)是一种 177Lu标记的生长抑素类似物肽，肽分子DOTA-TATE通过螯合剂与Lu-177结合，构建成新型复合药物。Lutathera注射到患者体内后，借助受体-配体的靶向识别作用，捕捉到肿瘤细胞，继而将放射性核素导入肿瘤组织，Lu-177释放高能量的β射线，最终杀灭肿瘤细胞。2017年，诺华以39亿美元收购Advanced Accelerator Applications（AAA），获得Lutathera。 Lutathera分别于2017、2018年在欧洲和美国上市，用于治疗生长抑素受体阳性的胃肠道胰腺神经内分泌肿瘤（GEP-NETs），这是首款FDA批准的放射性配体疗法。Lutathera 2023 年销售额达 6.05 亿美元，2024 前三个季度销售额为 5.34 亿美元。同时，诺华配合放射性配体疗法使用的放射性诊断药物镓[68Ga]戈泽肽注射液配制用药盒上市申请也同步获得受理，并被纳入优先审评。通过“诊疗一体化”的方案，先通过放射配体显像技术对肿瘤病灶进行搜寻定位，再通过针对靶点的放射配体疗法药物对癌细胞实施精准打击。此外，目前诺华还有多款在研核药，如 AAA603、AAA604、AAA614、AAA802、AAA817。其中 AAA604 靶向 Integrin beta-3/beta-5，针对胰腺癌的临床试验处于 I 期阶段。 AAA614 是诺华收购 Clovis Oncology 获得，作用于 FAP，针对实体瘤的 I 期临床试验正在进行中。 AAA802 和 AAA817 均靶向 PSMA，标记的核素均为 225Ac。在中国，诺华不仅已启动了多项放射性配体疗法的临床研究，还在与其他行业企业合作，积极布局放射性配体疗法生态圈。例如与GE医疗中国以及上药控股、重药控股合作，推动放射性配体疗法在中国市场的引入。诺华方面介绍称，放射配体疗法具有精准、高效、安全的药物机制，但放射性核素自身半衰期限制，必须在有效的时限内完成药品的制备、检验、放行、配送等流程，方能将药物送达患者。因此，这对药品的生产、检验和物流运输等环节提出了极高要求。值得一提的是，为了满足日益增长的市场需求，诺华在全球范围内建立了多个放射性药物生产基地，包括意大利、西班牙、美国和中国。7月2日，诺华在中国的首个放射性药品生产基地在浙江海盐举行奠基仪式，正式启动工程建设。此生产基地选址浙江省嘉兴市海盐县核技术应用（同位素）产业园，投资总额预计6亿元人民币，预计在2026年底投入生产。核药赛道全球布局除诺华以外，BMS、阿斯利康、默沙东、罗氏、礼来、拜耳、强生等跨国药企近年也通过股权投资、技术引进等多种方式切入了核药领域。据统计，2023年，全球核药领域融资18起，其中我国共有4起，融资金额合计超过13亿元。到了2024年，核药赛道非但没有熄火，反而越烧越旺，已然成为全球制药巨头们的必争之地。 9 月13日，赛诺菲与 RadioMedix 和 Orano Med 达成总额约 3.2 亿欧元的独家许可协议，共同开发基于同位素 212Pb 的放射性配体疗法（RLT）用于癌症治疗。 6月30日，Radionetics Oncology宣布，已经与礼来达成战略合作，将共同推进靶向GPCR的小分子放射性药物。根据协议条款，Radionetics收到了1.4亿美元预付款。作为战略合作的一部分，礼来还拥有未来以10亿美元收购Radionetics的独家选择权。 6月5日，核药CDMO公司Nucleus RadioPharma宣布完成了由阿斯利康投资的A轮扩展融资，具体金额暂未披露。业内认为，阿斯利康选择押注Nucleus RadioPharma，正是看中其作为CDMO，在核药研发、生产、制造、供应、临床资源等方面的综合能力。 5月21日，礼来与Aktis Oncology达成了针对放射性疗法的多靶点发现合作协议，总交易额超11亿美元。礼来于2023年10月斥资14亿美元收购POINT Biopharma，获得了177Lu为同位素、靶向PSMA的PNT2002等候选药物，正式进入放射性疗法赛道。 3月19日，阿斯利康宣布收购Fusion所有流通股，潜在交易总金额达24亿美元。通过此次交易，阿斯利康获得Fusion开发的放射性偶联物管线，包括最先进的项目FPI-2265，这是一种针对转移性去势耐受性癌症（mCRPC）患者的潜在新治疗方法。FPI-2265 靶向的前列腺特异性膜抗原（PSMA），这是一种在mCRPC中高度表达的蛋白质，目前正在进行2期试验。通过并购完成对供应链和生产配送能力的建设成为MNC入局的固定打法。当然，核药自身的属性也使得核药Biotech们被MNC收购是最佳的选择之一。与此同时，国内药企也积极抢占核药领域的商机，如据CDE公开信息，近期，瑞迪奥医药申报的锝[99mTc]肼基烟酰胺聚乙二醇双环RGD肽注射液(简称“99mTc-3PRGD2”)及注射用甲苯磺酸钠烟酰胺腙聚乙二醇双环RGD肽纳入CDE的优先审评名单。资料显示，99mTc-3PRGD2为瑞迪奥医药自主研发的放射性核素偶联药物(RDC)，是我国核医学放射诊断1类新药。再如恒瑞医药全资成立子公司天津恒瑞在成立仅3年多的时间内，已推进4款放射性核素偶联药物(RDC)进入临床，包括2款诊断用药镓[68Ga]伊索曲肽注射液、HRS-9815注射液，以及2款治疗用药镥[177Lu]氧奥曲肽注射液、HRS-4357注射液。另外，中国同辐、东诚药业这两家老牌核药企业在这一产业内的既有竞争优势显著。业内表示，随着核医学诊疗一体化的发展，以放射配体疗法为代表的放射性药物很有希望成为肿瘤治疗的新支柱，改变癌症治疗的未来。根据公开数据显示，目前国内已经有32款在研放射性药物。而远大医药、中国同辐等企业也开始在核药领域尝到甜头。如根据远大医药2024年中期业绩显示，得益于公司核药抗肿瘤诊疗板块收入的上涨，报告期内实现净利润约15.6亿港元，剔除汇率影响同比增长58%。中国同辐上半年的营收规模突破了28亿元，其中显像诊断及治疗用放射性药物方面实现收入8.64亿元，同比增长5.8%。此外，东诚药业的核药业务板块2023年也实现10.17亿元的收入，同比增长11.2%。结语诺华在核药赛道的快速进展和可观的销售数据，反过来也带动了全球核药市场的火热，为行业发展注入了强心剂。随着越来越多的药企加入，核药赛道正迎来前所未有的繁荣期，未来随着越来越多核药的上市和产业链的完善，核药势必能成长为新一代癌症主流疗法。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。本公众号发布的各类文章重在分享，如有侵权请联系我们，我们将会删除。联系我们 ABC 2025 展位火热预定中！扫码立即咨询电话：13816031174 （同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩

放射疗法优先审批临床3期

100 项与 (177镥)镥氧奥曲肽相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	V10XX04	DB13985

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
神经内分泌肿瘤	加拿大	Advanced Accelerator Applications USA, Inc.	2019-01-09
胃肠胰神经内分泌肿瘤	美国	Advanced Accelerator Applications USA, Inc.	2018-01-26
SSTR阳性胃肠胰神经内分泌肿瘤	欧盟	Advanced Accelerator Applications SA	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	挪威	Advanced Accelerator Applications SA	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	列支敦士登	Advanced Accelerator Applications SA	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	冰岛	Advanced Accelerator Applications SA	2017-09-26

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
胃肠胰神经内分泌肿瘤	申请上市	美国	Curium Pharma UK Ltd.	2024-07-09
大肠类癌	药物发现	葡萄牙	Advanced Accelerator Applications SA	2012-09-06
Somatostatin Receptor-Positive Neuroendocrine Tumor	药物发现	德国	Advanced Accelerator Applications SA	2012-09-06
Somatostatin Receptor-Positive Neuroendocrine Tumor	药物发现	比利时	Advanced Accelerator Applications SA	2012-09-06
Somatostatin Receptor-Positive Neuroendocrine Tumor	药物发现	西班牙	Advanced Accelerator Applications SA	2012-09-06
Somatostatin Receptor-Positive Neuroendocrine Tumor	药物发现	法国	Advanced Accelerator Applications SA	2012-09-06
Somatostatin Receptor-Positive Neuroendocrine Tumor	药物发现	葡萄牙	Advanced Accelerator Applications SA	2012-09-06
Somatostatin Receptor-Positive Neuroendocrine Tumor	药物发现	英国	Advanced Accelerator Applications SA	2012-09-06
Somatostatin Receptor-Positive Neuroendocrine Tumor	药物发现	意大利	Advanced Accelerator Applications SA	2012-09-06
Somatostatin Receptor-Positive Neuroendocrine Tumor	药物发现	美国	Advanced Accelerator Applications SA	2012-09-06

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03972488 (NETTER-2, CTgov)	临床3期	胃肠胰神经内分泌肿瘤	226	30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot)+2.5% Lys-Arg sterile amino acid solution+Lutathera (Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm))	選簾餘鏇築廠製製鏇淵(積繭衊網網網製壓構蓋) = 壓鏇壓鹽襯糧憲願壓夢鹹餘製醖範餘鏇繭顧餘 (觸齋鏇選鏇艱蓋壓餘膚, 襯願襯顧網糧糧餘鹽廠 ~ 築壓顧蓋糧網繭構糧築) 更多	-	2024-10-10
				High dose 60 mg octreotide long-acting repeatable (Octreotide LAR 60 mg (Control Arm))	選簾餘鏇築廠製製鏇淵(積繭衊網網網製壓構蓋) = 網選艱壓顧艱築選製觸鹹餘製醖範餘鏇繭顧餘 (觸齋鏇選鏇艱蓋壓餘膚, 網餘鏇網齋鬱鑰廠鏇蓋 ~ 鹹鹹遞憲鏇顧餘衊觸構) 更多
Biospace 人工标引	临床2期	脑膜瘤	20	Lutathera	(鑰蓋鑰窪艱築蓋簾壓憲) = 製鏇鏇獵艱壓鹹齋願選網壓築鹹願鬱醖鑰獵構 (鏇顧築餘壓壓鹹顧憲廠 ) 更多	积极	2024-09-30
ESMO2024	N/A	-	-	90Y DOTA-TATE	(醖鹽廠築鑰蓋壓膚簾鹹) = 網齋網遞齋膚鑰積鬱憲積膚壓獵積壓積繭廠淵 (鬱觸簾遞製網製壓齋範, 40 ~ 100.4) 更多	-	2024-09-16
				177Lu DOTA-TATE	(醖鹽廠築鑰蓋壓膚簾鹹) = 醖築衊夢鹹顧構獵憲獵積膚壓獵積壓積繭廠淵 (鬱觸簾遞製網製壓齋範, 40 ~ 100.4) 更多
ESMO2024	N/A	-	-	[177Lu]Lu-DOTA-TATE + octreotide 30 mg long-acting release (LAR)	(齋窪壓襯簾襯遞遞繭糧): OR = 10.43 (95% CI, 3.98 ~ 27.29), P-Value = <0.1 更多	-	2024-09-13
				octreotide 60 mg LAR
SNMMI2024	N/A	幻肢	-	Lu-177	(觸艱夢遞窪繭憲夢築窪) = Minimal changes in RCs were observed for acquisitions longer than 600 seconds 衊選鑰窪壓廠衊齋壓窪 (鏇壓選壓鏇構遞鏇醖衊 )	-	2024-06-09
				Lu-177 (StarGuide camera)
SNMMI2024	N/A	-	-	Lu-177 DOTATATE (Female patients)	鬱憲選鏇餘夢鬱憲鬱衊(襯鑰餘膚獵醖齋獵鑰觸) = 構淵壓鏇齋壓齋廠鹹窪鹽鹽糧製蓋蓋鹽繭獵構 (膚鹽壓鏇廠廠鹽膚糧獵, 0.8–1.8) 更多	-	2024-06-09
NCT03972488 (NETTER-2, ASCO2024) 人工标引	临床3期	胃肠胰神经内分泌肿瘤一线 somatostatin receptor-positive	226	177Lu-DOTATATE + octreotide LAR	(鏇簾鏇衊夢廠壓繭鏇獵) = 願鬱獵憲鏇艱膚襯範窪齋範廠鬱襯餘憲願鑰顧 (簾齋糧糧餘鬱壓憲蓋餘 ) 更多	积极	2024-05-24
				Octreotide LAR	(鹹顧壓壓糧鏇鹹遞夢鏇) = 獵構鬱鑰鏇鹽鬱築鏇艱繭遞糧衊廠顧願鹹築觸 (製顧夢醖網廠鬱獵襯艱 ) 更多
NCT02743741 (OZM 067, ASCO2024) 人工标引	N/A	神经内分泌肿瘤 Krenning score 3-4	195	177Lu-DOTATATE	(衊淵選範襯壓鑰夢觸鬱) = 膚鬱艱構膚膚襯襯鑰築醖夢鹽醖廠選獵齋獵鑰 (鏇顧齋齋憲廠衊糧鬱艱, 75 ~ 86) 更多	积极	2024-05-24
177Lutetium (ASCO2024)	N/A	-	57	177Lu-Dotatate	鬱壓鹽艱淵築衊蓋構醖(膚選選鬱繭觸鬱齋夢夢) = Therapy-related myeloid neoplasms [tMN, including myelodysplastic syndrome (MDS) & acute myeloid leukemia, (AML)] have been reported after177Lutetium (177Lu) for NET 膚衊網糧餘鬱製鏇憲壓 (餘衊選構構積顧糧積鹹 ) 更多	积极	2024-05-24
				177Lu-PSMA-617
ASCO_GU2024	N/A	转移性去势抵抗性前列腺癌 PSA levels	46	Lu-177	(壓廠觸壓遞壓鏇願遞襯) = 鹹蓋夢窪願築壓衊糧築淵選淵齋憲鏇選憲範膚 (鬱廠糧襯鏇積餘鑰製醖 ) 更多	积极	2024-01-25