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更新于：2025-06-01

Larotrectinib Sulfate

硫酸拉罗替尼

更新于：2025-06-01

概要

基本信息

药物类型

小分子化药

别名

larotrectinib、Larotrectinib sulfate (JAN/USAN)、拉罗替尼

+ [11]

靶点

TrkA x TrkB x TrkC

作用方式

拮抗剂、抑制剂

作用机制

TrkA 拮抗剂(神经生长因子受体Trk-A 拮抗剂)、TrkB抑制剂(神经营养性酪氨酸激酶受体-2型抑制剂)、TrkC抑制剂(生长因子受体NT-3抑制剂)

治疗领域

肿瘤神经系统疾病消化系统疾病+ [8]

在研适应症

局部晚期恶性实体瘤肿瘤NTRK融合阳性实体瘤+ [13]

非在研适应症-

原研机构

Array BioPharma, Inc.

Bayer AG

Loxo Oncology, Inc.

在研机构

Bayer AG

Bayer HealthCare Pharmaceuticals, Inc.

University of Calgary

+ [4]

非在研机构-

权益机构

Jnana Therapeutics, Inc.

Eli Lilly & Co.

Bayer Pharma AG

+ [3]

最高研发阶段批准上市

首次获批日期

美国 (2018-11-26),

NTRK融合阳性实体瘤

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、附条件批准 (中国)、孤儿药 (韩国)、加速批准 (美国)、突破性疗法 (美国)

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结构/序列

分子式C21H24F2N6O6S

InChIKeyPXHANKVTFWSDSG-QLOBERJESA-N

CAS号1223405-08-0

关联

项与硫酸拉罗替尼相关的临床试验

NCT06563999

/ Recruiting临床2期IIT

Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)

This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.

开始日期2024-11-01

申办/合作机构

中山大学

NCT05783323

/ Recruiting临床2期

Larotrectinib to Enhance RAI Avidity in Patients With Differentiated Thyroid Cancer Harboring NTRK Fusions

Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.

开始日期2024-02-14

申办/合作机构

The Children's Hospital of Philadelphia

[+1]

NCT05725200

/ Recruiting临床2期IIT

Study to Investigate Outcome of Individualized Treatment Based on Pharmacogenomic Profiling & Ex Vivo Drug Sensitivity Testing of Patient-derived Organoids in Patients With Metastatic Colorectal Cancer

The purpose of the study is to investigate the effect and side effects of personalized cancer treatment in patients with metastatic colorectal cancer (bowel cancer). All patients included must have metastatic bowel cancer and receive or have received at least two lines of standard chemotherapy. The cancer must not be available for surgery with curative intent.

开始日期2022-09-27

申办/合作机构

Oslo universitetssykehus HF

100 项与硫酸拉罗替尼相关的临床结果

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100 项与硫酸拉罗替尼相关的转化医学

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100 项与硫酸拉罗替尼相关的专利（医药）

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566

项与硫酸拉罗替尼相关的文献（医药）

2025-07-01·PEDIATRIC BLOOD & CANCER

Larotrectinib Monotherapy After a Subtotal Resection of Infantile Hemispheric Glioma With TPM3::NTRK1 Fusion

Letter

作者: Yoshimoto, Koji ; Koga, Yuhki ; Sakai, Yasunari ; Ohga, Shouichi ; Shunichiro, Toya ; Yokoyama, Satomi ; Oba, Utako ; Oda, Yoshinao

2025-07-01·BIOORGANIC CHEMISTRY

Discovery of novel diarylurea derivatives as potent type II TRK inhibitors for combating multiple acquired resistant mutants

Article

作者: Zhao, Wei ; Chu, Yong ; Xie, Zhendong ; Wang, Zhenghai ; Zhu, Xueyan ; Chen, Yinbo ; Zhao, Weiwei ; Zhang, Peng

Tropomyosin receptor kinases (TRKs), a superfamily of transmembrane receptor tyrosine kinases, have recently attracted extensive attention as promising cancer therapeutic targets since the FDA approval of Larotrectinib and Entrectinib. However, the emergence of acquired resistance due to secondary mutations in the TRKs domain significantly diminshes the therapeutic efficacy of these drugs, highlighting an urgent unmet clinical need. In this study, we designed a series of novel diarylurea derivatives as potential type II TRK inhibitors, using a molecular hybridization strategy. The representative compound 18d potently inhibited TRKA^{WT/G595R/G667C} with IC₅₀ values of 0.82 nM, 1.82 nM, and 0.12 nM, respectively. It also showed superior antiproliferative activities against both BaF3-LMNA-TRKA^G595R and BaF3-LMNA-TRKA^G667C cell lines (IC₅₀ = 23.76 nM and 0.33 nM, respectively), outperforming Repotrectinib (IC₅₀ = 28.14 nM and 25.69 nM, respectively). Collectively, compound 18d can be used as a promising lead candidate for further optimization in the development of therapies targeting drug-resistant TRK mutants.

2025-06-01·ESMO Open

Efficacy and safety of larotrectinib as first-line treatment for patients with TRK fusion cancer

Article

作者: Italiano, A ; Hong, D S ; Laetsch, T W ; Tahara, M ; Xu, R-H ; De La Cuesta, E ; Neu, N ; Drilon, A ; Mussi, C E ; Bernard-Gauthier, V ; Orbach, D ; Shen, L ; McDermott, R ; Dierselhuis, M P

BACKGROUND:

Larotrectinib is a first-in-class, highly selective tropomyosin receptor kinase (TRK) inhibitor approved for tumour-agnostic use in patients with TRK fusion cancer. Data on treatment-naïve adult and paediatric patients or the subset of treatment-naïve paediatric patients who discontinued larotrectinib after surgery or achieving durable clinical benefit are unknown.

MATERIALS AND METHODS:

Patients with treatment-naïve (no prior systemic therapy) metastatic/unresectable TRK fusion cancer from three larotrectinib clinical trials [NCT02122913, NCT02637687 (SCOUT) and NCT02576431 (NAVIGATE)] were included. Responses were assessed by an independent review committee (RECIST v1.1). SCOUT-enrolled patients could electively discontinue larotrectinib after surgical resection of disease, or ongoing non-surgical complete/partial response (≥1 year) or stable disease (≥2 years) in a 'wait-and-see' approach.

RESULTS:

As of 20 July 2023, 101 patients were enrolled, with a median age of 37 years (range 0-90 years). There were 14 different tumour types; the most common were non-infantile fibrosarcoma (IFS) soft tissue sarcoma (30%), IFS (18%), salivary gland carcinoma (18%) and thyroid carcinoma (17%). The overall response rate was 77% [95% confidence interval (CI) 68% to 85%]. Median duration of response, progression-free survival and overall survival were 59 months [95% CI 33 months-not estimable (NE)], 61 months (95% CI 33 months-NE) and not reached, respectively. Twenty-five of 42 SCOUT-enrolled patients entered a 'wait-and-see' period; at the data cut-off time, the 'wait-and-see' period was ongoing in 12 of these patients. Seven of 13 patients who exited the first 'wait-and-see' period had progressive disease and resumed larotrectinib; five of these seven patients had a response to re-treatment. Most treatment-related adverse events were grade 1/2.

CONCLUSIONS:

Larotrectinib achieved extremely durable responses, extended survival and had a favourable safety profile in treatment-naïve patients with TRK fusion cancers, supporting its use in this population. Elective discontinuation of larotrectinib may be feasible in selected paediatric patients, with response achievable after restarting larotrectinib in cases of recurrent off-therapy disease.

216

项与硫酸拉罗替尼相关的新闻（医药）

2025-05-29

·Illumina因美纳

纳新逐光，ASCO2025热点前瞻——全景变异分析CGP NGS与肿瘤精准研究实践

作为全球肿瘤学领域规模最大与最具影响力的学术盛会之一，2025年美国临床肿瘤学会（ASCO）年会将于5月30日至6月3日在美国芝加哥隆重举行。基于已发布数据，今年ASCO年会共收到7,775篇摘要，其中由中国学者主导的口头汇报达74项，数量再创新高，内容涵盖基础研究、临床转化、精准医疗及免疫治疗等多个前沿领域，充分彰显中国在肿瘤研究领域的持续突破与创新进展。本届ASCO年会以“知识化为行动：共创美好未来（Driving Knowledge to Action: Building a Better Future）”为主题，强调前沿科学与尖端技术为肿瘤精准医学带来的深远推动。ASCO年会开幕在即，我们精选了近年来肿瘤精准医学领域的关键技术进展，带大家一起提前“热身”！由因美纳团队将为大家带来的“纳新逐光，ASCO2025热点前瞻”系列报道，聚焦业内高度关注的单细胞测序、空间组技术、甲基化芯片分型、全景变异分析CGP NGS和全基因组测序WGS等技术在肿瘤精准研究中的最新进展与客户案例。与大家一同“温故而知新”，在ASCO学术盛宴中汲取更多新知，共创肿瘤精准医学美好未来。生物标志物驱动的个体化精准治疗，是2025年ASCO大会已发布信息中被反复提及的关键词。根据多项国内外最新指南与研究，更广泛的肿瘤基因检测已成为大势所趋。2024年8月，FDA批准了首个泛癌种全景变异分析（Comprehensive Genomic Profiling, CGP）NGS伴随诊断IVD试剂盒——TruSight™ Oncology Comprehensive。这一里程碑事件，不但标志着更全面基因测序的临床认可，也为广泛NGS检测的市场准入进一步打通渠道，从而惠及更多患者。为了更好了解2025 ASCO中“生物标志物驱动精准治疗”的行业前沿，本期内容中我们将聚焦全景变异分析CGP NGS，解析这一精准研究利器为行业带来的颠覆性突破。生物标志物驱动的精准治疗：CGP NGS检测的颠覆性价值随着FDA批准拉罗替尼和恩曲替尼用于NTRK融合的实体瘤患者，再到2022年批准达拉非尼联合曲美替尼用于BRAF V600E突变的实体瘤患者，以及TMB和MSI作为生物标志物用于患者的诊疗，“不限癌种”靶向药物的陆续获批打破了以往药物以肿瘤类型作为适应症的界限，开启了以特定分子变异指导肿瘤用药的精准医学时代。ESMO精准医学工作组2024年更新了ESMO NGS检测指南，较2020版扩大了NGS推荐建议范围，在更多晚期癌种中推荐了更广泛的NGS检测。目前根据2024版ESMO NGS检测指南推荐，建议在晚期的非鳞状非小细胞肺癌、前列腺癌、结直肠癌、胆管癌、卵巢癌、乳腺癌（新增）和罕见肿瘤（新增，包括胃肠道间质瘤、肉瘤、甲状腺癌和原发不明肿瘤）患者中进行NGS检测。同时还建议晚期癌症患者可进行泛癌种NGS检测，以寻找泛实体瘤用药的可能性1。在这一诊疗模式下，CGP NGS检测因其全面性和高效性，成为精准医学的重要技术。图1. 2024版ESMO NGS检测指南推荐检测的泛癌种变异基因化分型成果正式纳入肿瘤命名体系，标志着分子诊断成为核心依据之一。全面覆盖，精准指导CGP NGS检测能够同时分析数百个基因的突变、拷贝数变异（CNV）、基因融合、微卫星不稳定性（MSI）和肿瘤突变负荷（TMB）等标志物。Intermountain Precision Genomics实验室主任Jeremy Wallentine博士指出2，“从单基因或单个生物标志物检测到综合panel检测方法的转变是由一系列因素驱动的，其中包括单一综合panel的固有效率，这在癌症和其它组织有限的样本中非常关键”， CGP可将多个生物标志物的检测整合到单个多重检测中，无需进行连续检测，这种单次检测不仅可以评估普通的生物标志物，还可以评估TMB等复杂的生物标志物，进而更快速地提供检测结果、节约活检样本、减少再次进行活检的风险和成本3。推动NGS大panel改善参与临床研究的比例，避免患者错失机会以生物标志物为导向的临床试验研究可通过合适的生物标志物确定亚组人群，根据其识别亚组并制定个体化治疗的临床试验方案,从而使患者接受更有益的治疗、加速药物研发进程4,5。在肿瘤诊疗中，临床研究为晚期癌症患者带来了更多希望，然而尽管多项国际指南都推荐晚期患者参与，当前全球的研究注册比例仍然很低。这让很多患者错失了潜在治疗机会。对药企和临床机构来说，参与临床研究（Clinical trial participation，CTP）的低比例，延长了药物研发上市周期，增加研发成本，最终影响患者的治疗机会。通过CGP检测，能够筛选出适合特定临床试验的患者群体，提高试验的成功率，在2024年的一篇ASCO会议摘要（摘要e13508）中，因美纳与Optum的研究团队发现，晚期癌症患者的整体参与临床研究CTP比例很低（3%），但是开展了生物标志物检测患者有更高的CTP比例。临床突破：TSO Comprehensive——首个获得FDA批准的CGP伴随诊断检测试剂盒随着NGS技术的进步，近年来美国食品药品监督管理局（FDA）批准的NGS伴随诊断产品逐渐增多，回顾FDA批准的肿瘤分子诊断产品，可发现一次性覆盖更多标志物、可兼容丰富样本类型的NGS成为肿瘤分子诊断的主流。2024年8月，美国食品药品监督管理局（FDA）批准了因美纳体外诊断产品（IVD）TruSight™ Oncology (TSO) Comprehensive检测试剂盒及其首批两种伴随诊断（CDx）适应症。作为首个FDA获批的泛癌种全景变异分析（CGP）NGS伴随诊断IVD试剂盒，该产品单次检测可以覆盖500多个基因对患者的实体瘤进行分析，有助于提高发现免疫肿瘤生物标志物或临床可操作生物标志物的可能性，从而确定靶向治疗方案或临床试验入组。TSO Comprehensive检测试剂盒的单独CE标志版本已于2022年在欧洲上市。在大中华地区，TruSight Oncology Comprehensive已于2024年5月1日被纳入中国台湾地区的全民健保体系，成为亚洲范围内进入健康保险体系伴随诊断解决方案的“先行者” 。今年五月，TruSight Oncology (TSO) Comprehensive获得日本厚生劳动省批准上市,有望为日本患者提供更多精准肿瘤治疗选择。通过与制药公司合作，因美纳正在开发更多伴随诊断应用，这些应用将在获得相应的监管批准后添加到TSO Comprehensive检测产品中。这些伴随诊断检测应用将助力突破性的靶向治疗和免疫疗法的推出，改善癌症患者的生活质量。科研利器——TSO 500的杰出数据表现为满足客户在多样性和可扩展性方面的不同需求，TSO产品线涵盖体外诊断的（TSO Comprehensive）和仅供研究使用的（TSO 500产品）解决方案，适用于一系列低、中、高通量仪器。TSO 500凭借其全面的检测能力和优异的数据表现，在肿瘤精准研究中展现出独特价值，目前在全球范围超670个用户中，已累积超60万份检测样本（截止2024年12月）与大量科研成果产出。TSO 500通过DNA+RNA共检方式更好的实现RNA融合检出TSO 500使用DNA+RNA不同核酸类型，更好检测RNA水平的突变，通过基于RNA样本的融合检测可实现发现个更多的融合等变异。在一项MSKCC发表的研究中，仅基于DNA样本的MSK-IMPACT检测为阴性的肺腺癌患者，重新基于RNA测序后，13%发现了新的临床可干预突变6。在一项真实世界研究中，研究者利用TSO 500方案对涉及35种实体瘤的19591份FFPE样本进行分析，结果显示，该研究中共鉴定出73个致癌或可能致癌的NTRK融合，总发生率为0.35%。发生率较高的肿瘤类型包括胶质母细胞瘤（1.91%）、小肠肿瘤（1.32%）和头颈部肿瘤（0.95%）。图2 在不同肿瘤中发现的致癌或可能致癌NTRK融合变异同时发现 NTRK 融合在所有肿瘤类型中存在多种染色体内和染色体间的融合伴侣基因，包括 ETV6、TPM3、LMNA等。大多数 NTRK 融合与其他基因组驱动突变互斥，然而，近三分之一的肿瘤样本（29%）至少存在一种共现的基因组驱动突变，这可能会影响治疗决策。该研究结果突出了RNA杂交捕获测序在识别NTRK融合中表现出高敏感性，尤其是对新型融合伴侣的检测能力优于DNA测序7。TSO 500 临床验证数据显示可靠的性能和准确性TSO 500通过优异的设计与分析流程实现强大的检测能力，包括小变异（SNV以及InDel）以及同源重组修复缺陷（HRD）、TMB等复杂变异的检出。其中HRD、TMB和MSI等复杂生物标志物检测，与目前全球公认的HRD、TMB的评估方法保持高度一致。在2025年由梅奥诊所发表的一项最新研究，进一步对TSO 500的检测表现进行了临床验证。研究结果显示，在该研究中，评估了超过 20 种肿瘤类型中提取的 104 份 DNA 样本和 223 份 RNA 样本。该检测使用 40 ng的输入 DNA 和 RNA 时表现稳健，使用 60 ng的输入 DNA 时结果进一步改善。肿瘤百分比显著影响检测性能，在肿瘤百分比大于 50% 和大于 20% 时，所有变异的检测率分别为 93% 和 85% 以上。所有变异类型的精确率均超过 93%，包括变异等位基因频率≥5% 的SNV和InDel。除 TMB 外，所有变异类型的准确率均≥97%，与参考方法相比，TMB 的准确性为 83.3%。总体而言，TSO 500 检测在检测所评估的标志物方面表现出了强大的性能和可靠的准确性8。图3. 梅奥诊所针对TSO 500的临床验证TSO 500升级版本提供更便利的检测流程与更好的检测表现TSO 500包括组织版本以及ctDNA版本，其中ctDNA版本已经在2023年推出TSO 500 ctDNA v2版本，实现了更便捷的建库操作以及更优的检测表现。TSO 500 tissue v2版本也在推进计划中，新的版本同样具备更便捷的操作与数据表现，并且新的版本中将金标准Myriad HRD现已包含在试剂盒中，并提供简化的工作流程。结语肿瘤治疗范式正在发生深刻转变，正式迈入“生物标志物精准驱动”的新时代。新一代的CGP NGS在肿瘤精准研究与临床检测中的日趋成熟，有望为患者带来更多的治疗机会与希望。在线订购了解更多如果您希望获得更多因美纳肿瘤精准研究前沿产品的相关资料。欢迎扫描下方二维码，我们将通过邮件与您分享更多详情。仅供研究使用，不得用于诊断。M-CN-00496参考文献：Mosele M F, Westphalen C B, Stenzinger A, et al. Recommendations for the use of next-generation sequencing (NGS) for patients with advanced cancer in 2024: a report from the ESMO Precision Medicine Working Group[J]. Annals of Oncology, 2024, 35(7): 588-606.https://www.illumina.com.cn/areas-of-interest/cancer/ngs-in-oncology/cgp.htmlLindeman NI, Cagle PT, Aisner DL, et al. Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors: Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. J Mol Diagn. 2018 Mar;20(2):129-159.Mandrekar SJ,Sargent DJ.Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges.[J].2009,27(24).宋佳丽,孙凤宇,刘芝霖,李康,侯艳.以生物标志物为导向的临床试验研究[J].中国卫生统计,2023,40(5):791-795,800.DOI:10.11783/j.issn.1002-3674.2023.05.037.Benayed R, Offin M, Mullaney K, et al.High yield of RNA sequencing for targetable kinase fusions in lung adenocarcinomas with no mitogenic driver alteration detected by DNA sequencing and low tumor mutation burden.Clin Cancer Res.2019 August 01; 25(15): 4712–4722Wallen ZD, Tierno M, Schnettler E, Roos A, Green M, Amoah K, Previs RA, Hastings S, Pabla S, Jensen TJ, Caveney B, Eisenberg M, Sathyan P, Ramkissoon SH and Severson EA (2025) RNA hybrid-capture next-generation sequencing has high sensitivity in identifying known and less characterized oncogenic and likely oncogenic NTRK fusions in a real-world standard-of-care setting. Front. Genet. 16:1550706. doi: 10.3389/fgene.2025.1550706Al-Kateb H, Knight SM, Sivasankaran G, Voss JS, Pitel BA, Blommel JH, Jerde CR, Rumilla KM, Lee JL, Mattson NR, Lauer KP, Zimmerman Zuckerman EA, Hofich CD, Milosevic D, Thompson J, Tillmans LS, Stai TT, Dasari S, Pryzbylski AL, Mullineaux LG, Ida CM, Jenkins RB, Gupta S, Kipp BR, Halling KC. Clinical Validation of the TruSight Oncology 500 Assay for the Detection and Reporting of Pan-Cancer Biomarkers. J Mol Diagn. 2025 Apr;27(4):292-305. doi: 10.1016/j.jmoldx.2025.01.002. Epub 2025 Jan 31. PMID: 39894076.关于TruSight™ Oncology 500产品组合TSO 500产品组合是一项仅供科研使用的综合性泛癌种检测产品组合，可通过组织或液体（血液）活检进行全景变异分析。TSO 500 产品组合利用肿瘤样本中的 DNA 和 RNA（液体活检分析仅利用 DNA）来识别对癌症发生和进展至关重要的关键变异，如小 DNA 变异（单核苷酸变异，indels）、融合、剪接变异和拷贝数变异。此外，它还能评估关键基因组特征，如肿瘤突变负荷（TMB）、微卫星不稳定性（MSI）和同源重组缺陷（HRD）。关于TruSight Oncology ComprehensiveTruSight Oncology Comprehensive是一种定性体外诊断检测产品，它使用因美纳NextSeq™ 550Dx基因测序仪，利用从实体恶性肿瘤患者的福尔马林固定、石蜡包埋（FFPE）肿瘤组织样本中提取的核酸，通过靶向新一代测序技术检测517 个基因的变异。该产品可用于检测DNA中的单核苷酸变异、多核苷酸变异、插入和缺失，以及RNA中24个基因的融合和一个基因的剪接变异。该检测还能报告肿瘤突变负荷（TMB）得分。根据已批准的治疗产品标签，该检测可用作伴随诊断，以确定哪些癌症患者可从表1所列的靶向治疗中获益。此外，该检测还可提供肿瘤分析信息，供有资质的医疗专业人士根据专业肿瘤指南为实体瘤恶性肿瘤患者提供医疗建议。除预期用途说明表1中所列出的基因组结果外，其他基因组结果对任何特定治疗产品的标签使用均不具决定性或规定性。表1：伴随诊断指征仅供体外诊断使用。并非在所有地区和国家均有销售。中国NMPA暂未获批。.

ASCO会议诊断试剂

2025-05-29

·Illumina因美纳

因美纳扩展临床肿瘤学产品组合，树立全新诊疗标准，加速精准治疗可及

美国加利福尼亚州圣迭戈——2025年5月28日，因美纳公司（纳斯达克股票代码：ILMN）宣布扩展肿瘤临床产品组合，推出全新解决方案以推动精准肿瘤学的发展，进一步提升诊疗标准。公司广泛的临床产品组合，将加速让更多癌症患者获得精准治疗的机会。因美纳的肿瘤检测产品组合与体外诊断解决方案将于在芝加哥举行的2025年美国临床肿瘤学会年会（ASCO）期间亮相。肿瘤检测的可及是实现癌症精准治疗承诺的关键。”因美纳首席商务官 Everett Cunningham 表示。“凭借不断扩展的、可上市的临床解决方案组合，我们正为临床医生及其患者开启标准治疗新模式。通过采用 TSO Comprehensive 与 Pillar oncoReveal CDx，更多实验室将能够在院内完成肿瘤分子分型检测，使肿瘤科医生能够快速了解疾病驱动基因，从而为患者匹配最合适的治疗方案。”因美纳TruSight™（TSO）Comprehensive 是全球首款也是唯一一款获得FDA批准、可上市的全景变异分析体外诊断试剂盒，具备泛癌种伴随诊断功能，可同时评估 DNA 和 RNA。该方案帮助医生通过全面的肿瘤分子分型，快速为癌症患者精准匹配靶向治疗方案。目前，因美纳在全美的客户，包括社区肿瘤医疗护理机构、区域性医院与卫生系统、学术医疗机构等，已陆续将 TSO Comprehensive 纳入临床使用。本月，路易斯维尔大学健康系统的路易斯维尔大学医院（UofL Health – UofL Hospital）成为了首家正式为患者提供该项检测服务的因美纳客户。我们非常高兴能够将 TSO Comprehensive 带给我们的患者和医疗服务团队。”路易斯维尔大学医学院病理学与实验医学系血液学、细胞遗传学与分子病理学助理教授、主任 Mustafa Al-Kawaaz 医学博士表示，“拥有院内可用的肿瘤全景变异分析方案，将帮助我们医疗团队更快作出精准治疗决策。”TSO Comprehensive 目前已被美国医疗保险和医疗补助服务中心（CMS）纳入保险报销范围，并获得多数商业医疗保险计划的覆盖。因美纳也在持续推进该产品在美国的生物标志物适应症与伴随诊断应用的扩展。此外，公司今日还宣布，TSO Comprehensive 体外诊断试剂盒已获得日本监管机构的上市批准。因美纳深化与Pillar合作，提升临床诊断可及性因美纳将进一步扩展其体外诊断产品线，并于今夏起与Pillar Biosciences合作，为客户提供 Pillar oncoReveal® CDx 体外诊断试剂盒。该产品用于检测22个癌症相关的关键基因遗传变异，适用于既往已确诊的实体瘤患者。今年4月，Pillar 宣布 oncoReveal® CDx 已获美国医疗保险和医疗补助服务中心（CMS）覆盖，纳入联邦医疗保险报销范围。目前美国已有超过6,600万人享有联邦医疗保险保障，oncoReveal® CDx 纳入医保报销目录，将有助于确保这项高准确性、可操作性强且可报销的新一代测序检测，能够在全美范围内被临床实验室和生物医药企业广泛采用。” Pillar首席运营官 Brian Wright 表示，“这也将有助于加快治疗决策的制定，让更多来自不同地区的患者获得更好的治疗结局。”想了解更多有关因美纳在ASCO年会上的相关信息，可前往因美纳展位33101进行参观。关于TruSight Oncology Comprehensive (TSO Comprehensive)TSO Comprehensive 是目前全球首个且唯一获美国食品药品监督管理局（FDA）批准的可上市的全景变异分析体外诊断试剂盒，具备泛癌种伴随诊断功能，可同时评估 DNA 和 RNA。全景变异分析基于新一代测序技术，可通过单次检测覆盖数百个基因，涵盖多项已被临床指南和研究验证的癌症相关生物标志物，为制定治疗方案提供指导。TSO Comprehensive 可针对实体瘤对超过500个基因进行检测，从而提高识别免疫肿瘤学治疗标志物及具有临床干预价值的生物标志物的可能性，进而拓展包括靶向治疗或临床试验入组等治疗选择。该试剂盒的欧洲 CE 认证版本亦已同步上市。TSO Comprehensive 目前已获得FDA批准，用于识别神经营养酪氨酸受体激酶（NTRK）基因融合阳性的成人和儿童实体瘤患者，在临床指导下，这些患者可能从拜耳公司的VITRAKVI®（拉罗替尼）治疗中获得改善。该检测还被批准用于识别局部晚期或转移性转染重排（RET）融合阳性非小细胞肺癌（NSCLC）成人患者，在临床指导下，这些患者可能会从礼来公司的RETEVMO®（塞普替尼）治疗中获得改善。如需了解更多关于 TruSight Oncology Comprehensive 的信息，请点【阅读原文】。关于oncoReveal CDxPillar oncoReveal® CDx 是一款基于新一代测序技术的体外诊断试剂盒，用于检测 22 个基因中的单核苷酸变异、插入和缺失突变，适用于既往已确诊的实体瘤患者。该试剂盒已作为伴随诊断获得批准，用于识别可能从表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗中获益的非小细胞肺癌（NSCLC）患者（类别适应证），以及识别可能适合接受西妥昔单抗和帕尼单抗治疗的结直肠癌患者中具有 KRAS 基因变异的个体。前瞻性声明本新闻稿包含涉及风险和不确定性的前瞻性声明。我们的业务会受到一些重要因素的影响，这些因素可能导致实际结果与任何前瞻性陈述存在实质性差异：(i) 开发、制造和推出新产品和服务所固有的挑战；(ii) 客户对新产品和服务的接受程度和满意度；(iii) 立法、监管和经济发展变化，包括我们最近提交的 10-K 表和 10-Q 表，或在公开电话会议中披露的信息，电话会议的日期和时间已事先公布。我们没有义务，也不打算更新这些前瞻性声明，审查或确认分析师的预期，或提供有关本季度进展的中期报告或更新。因美纳公司致力于推动和激发基因组学的发展而不断改善人类健康。专注创新使我们成为全球基因测序和芯片技术的领导者，并为全球范围的科研、临床和应用市场客户提供专业服务。我们的产品广泛应用于生命科学、肿瘤学、生殖保健、农业及其他新兴领域。欲了解更多信息，请访问www.illumina.com.cn或关注因美纳微信公众号。联系方式投资者：Brian BlanchettIR@illumina.com媒体：Christine DouglassPR@illumina.com.

诊断试剂ASCO会议上市批准

2025-05-28

·PRNewswire

Illumina expands clinical oncology portfolio unlocking new standard of care and access to precision therapies

Following FDA approval last year, Illumina's TSO Comprehensive test gains broad payer reimbursement, expanding access to comprehensive genomic profiling to match patients with targeted therapiesIllumina's IVD portfolio will also expand to offer Pillar oncoReveal® CDx, the newest panel to deliver critical companion diagnostic testing using the Illumina MiSeq™ Dx System SAN DIEGO, May 28, 2025 /PRNewswire/ -- Illumina Inc. (NASDAQ: ILMN) today announced an expanded clinical oncology portfolio, unlocking the next new solutions to advance precision oncology and improve the standard of care. The company's broad range of clinical offerings will accelerate access to precision oncology for more patients with cancer. Illumina tumor profiling and in vitro diagnostic (IVD) solutions will be on display at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Continue Reading Illumina expands its clinical oncology portfolio to provide customers with a suite of tumor profiling solutions, and expand patient access to critical precision oncology therapies. "Access to tumor profiling is essential to deliver on the promise of precision cancer care," said Everett Cunningham, chief commercial officer of Illumina. "With our growing portfolio of distributable clinical solutions, we are unlocking the next new standard of care for clinicians and their patients. With TSO Comprehensive and Pillar oncoReveal CDx, more labs can perform tumor profiling in-house, allowing oncologists to rapidly understand the genomic drivers of disease, and match their patients to the best possible therapies." Illumina TruSight™ (TSO) Comprehensive is the first and only FDA-approved test offering a distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, evaluating both DNA and RNA. This enables clinicians to rapidly match cancer patients with targeted therapies using comprehensive tumor profiling. Illumina customers across the US -- in community oncology care practices, regional hospitals and health systems, and academic medical centers -- are integrating TSO Comprehensive into their clinical practice. This month, UofL Health – UofL Hospital became the first Illumina customer to begin offering the test to patients. "We are excited to bring TSO Comprehensive to our patient and provider community. Access to an in-house comprehensive tumor profiling solution will allow our care teams to deliver faster precision therapy decisions for our patients," said Mustafa Al-Kawaaz, MD, assistant professor and director of Hematology, Cytogenetics and Molecular Pathology in the Department of Pathology and Laboratory Medicine at the University of Louisville School of Medicine. TSO Comprehensive is now covered under Medicare plans by the Centers for Medicare & Medicaid Services (CMS), as well as most commercial health plans. Illumina continues to pursue expanded biomarker indications and CDx claims for TSO Comprehensive in the US. Also announced today, the IVD kit has now received regulatory approval in Japan. Illumina expands partnership with Pillar Biosciences to boost access to clinical diagnostics Expanding its IVD portfolio, Illumina is partnering with Pillar Biosciences to offer Pillar oncoReveal CDx to Illumina customers beginning this summer. The oncoReveal CDx IVD kit is used for the detection of genetic variations in 22 genes and is intended for previously diagnosed patients with solid tumors. In April, Pillar announced that oncoReveal CDx received nationwide Medicare coverage by the CMS. 'With over 66 million people in the US covered by Medicare, reimbursement of oncoReveal CDx will help ensure that highly accurate, actionable, and reimbursable next-generation sequencing testing is available to clinical laboratories and biopharmaceutical companies," said Brian Wright, chief marketing officer of Pillar Biosciences. "In turn, this enables faster treatment decisions and improved outcomes for everyone, everywhere." Learn more about Illumina at ASCO and visit us at Booth 33101. About TruSight Oncology Comprehensive TSO Comprehensive is the first and only FDA-approved test offering a distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, evaluating both DNA and RNA. Comprehensive genomic profiling is a next-generation sequencing approach that uses a single assay to assess hundreds of genes—including relevant cancer biomarkers, as established in guidelines and clinical trials—for therapy guidance. TSO Comprehensive interrogates over 500 genes to profile a patient's solid tumor, helping to increase the likelihood that an immuno-oncology biomarker or clinically actionable biomarkers will be identified. This can open up options such as targeted therapy or clinical trial enrollment. A separate CE-marked version of TSO Comprehensive is also available in Europe. TSO Comprehensive is FDA approved as a CDx to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions that may benefit from treatment with Bayer's VITRAKVI (larotrectinib). The test is also approved to identify adult patients with locally advanced or metastatic rearranged-during-transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) that may benefit from treatment with Lilly's RETEVMO (selpercatinib). To learn more about TruSight Oncology Comprehensive, click here. About oncoReveal CDx Pillar oncoReveal® CDx is an next-generation-sequencing-based IVD kit for the detection of SNVs, insertions, and deletions in 22 genes, intended for previously diagnosed patients with solid tumors. The kit is approved as a CDx to identify patients who may benefit from epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy (class approval) in NSCLC and ERBITUX and VECTIBIX for KRAS in CRC. oncoReveal® CDx is FDA approved on the Illumina MiSeq Dx System. Use of forward-looking statements This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing, manufacturing, and launching new products and services; (ii) customer uptake of, and satisfaction with, new products and services; and (iii) legislative, regulatory and economic developments, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter. About Illumina Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on X, Facebook, LinkedIn, Instagram, TikTok, and YouTube. Contacts Investors: Brian Blanchett [email protected] Media: Christine Douglass [email protected] SOURCE Illumina, Inc.

ASCO会议

100 项与硫酸拉罗替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11138	硫酸拉罗替尼	L01XE53	DB14723

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
局部晚期恶性实体瘤	澳大利亚	Bayer Australia Ltd.	2020-09-07
肿瘤	加拿大	Bayer, Inc.	2019-07-10
NTRK融合阳性实体瘤	美国	Bayer HealthCare Pharmaceuticals, Inc.	2018-11-26

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
分化型甲状腺癌	临床2期	美国	Bayer AG	2024-02-14
脑转移瘤	临床2期	美国	Bayer AG	2015-12-16
脑转移瘤	临床2期	中国	Bayer AG	2015-12-16
脑转移瘤	临床2期	日本	Bayer AG	2015-12-16
脑转移瘤	临床2期	澳大利亚	Bayer AG	2015-12-16
脑转移瘤	临床2期	加拿大	Bayer AG	2015-12-16
脑转移瘤	临床2期	捷克	Bayer AG	2015-12-16
脑转移瘤	临床2期	丹麦	Bayer AG	2015-12-16
脑转移瘤	临床2期	法国	Bayer AG	2015-12-16
脑转移瘤	临床2期	德国	Bayer AG	2015-12-16

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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


NCT02576431, NCT02122913, NCT02637687 (ASCO2025)	N/A	RET融合阳性甲状腺癌	31	Larotrectinib 100 mg BID	獵積獵鹽築獵願憲膚窪(餘鑰憲選築鬱願遞衊襯) = 鹽選簾繭簾鑰構願廠鹹齋願餘淵醖製製壓糧鹹 (構鬱夢繭衊鬱網艱襯蓋, 41 ~ 79) 更多	积极	2025-05-30
NCT02637687, NCT02576431, NCT02122913 (ASCO2025)	N/A	中枢神经系统肿瘤	304	Larotrectinib 100 mg BID	鬱顧醖簾壓艱糧製窪餘(廠襯鑰壓顧窪鹽壓遞鑰) = TRAEs were mainly Grade 1/2 (n = 189; 62%). Grade 3/4 TRAEs occurred in 71 (23%) pts. Five (2%) pts discontinued due to TRAEs. 糧願積醖蓋構膚繭餘糧 (構窪艱淵壓遞範顧繭構 ) 更多	积极	2025-05-30
NCT02122913, NCT02576431 (ASCO2025)	N/A	肺癌	32	Larotrectinib 100 mg	艱製衊構壓糧獵鬱築獵(鬱餘簾鹹淵遞夢齋製糧) = Grade 3/4 TRAEs were reported in 10 (31%) patients 齋衊窪蓋膚願鹽築鏇淵 (糧餘鏇廠遞膚築襯衊範 ) 更多	积极	2025-05-30
NCT02576431 \| NCT02637687 \| NCT02122913 (Pubmed \| JCO Precis Oncol)	N/A	肿瘤 tropomyosin receptor kinase fusion	164	Larotrectinib	鑰膚簾範鬱窪壓鬱觸膚(衊繭襯廠鹹繭簾淵鑰蓋) = 鬱艱憲廠鏇夢鏇壓廠壓範積膚壓餘觸獵鹽壓鑰 (餘積選鹽窪構廠簾選餘 ) 更多	积极	2025-04-01
	N/A	肿瘤 tropomyosin receptor kinase fusion	164	Larotrectinib (Standard of Care (SOC))	鑰膚簾範鬱窪壓鬱觸膚(衊繭襯廠鹹繭簾淵鑰蓋) = 選膚鹹蓋構鑰願壓齋鬱範積膚壓餘觸獵鹽壓鑰 (餘積選鹽窪構廠簾選餘 ) 更多	积极	2025-04-01
NCT03834961 (ADVL1823, Pubmed \| J Clin Oncol)	临床2期	纤维肉瘤 NTRK fusion-positive	33	Larotrectinib	顧鏇齋襯鑰醖襯遞餘繭(餘廠窪鹽廠網膚製構鏇) = 網簾膚餘壓壓範蓋範構糧艱製範鹽醖簾鹽淵網 (艱繭齋顧鏇遞窪壓餘獵, 72.7 ~ 98.6) 更多	积极	2025-04-01
NCT03834961 (ADVL1823, Pubmed \| J Clin Oncol)	临床2期	纤维肉瘤 NTRK fusion-positive	33	Placebo	顧鏇齋襯鑰醖襯遞餘繭(餘廠窪鹽廠網膚製構鏇) = 築鏇範壓膚醖遞獵鹽鬱糧艱製範鹽醖簾鹽淵網 (艱繭齋顧鏇遞窪壓餘獵, 32.3 ~ 83.7) 更多	积极	2025-04-01
ESMO_ELCC2025	N/A	肺癌 NTRK gene fusions	32	Larotrectinib	艱夢獵選獵壓壓鹹淵積(襯憲憲鏇繭鬱廠積淵糧) = predominantly Grade 1/2 範積鹽醖艱築艱艱遞憲 (鹹憲遞網範積積繭範壓 )	积极	2025-03-26
NCT02576431 \| NCT02637687 \| NCT02122913 (ESMO_SRC2025)	N/A	肿瘤一线 NTRK gene fusions	60	Larotrectinib	範淵觸憲窪鹹醖艱積繭(憲願鏇艱築築憲顧窪遞) = Treatment-related adverse events (TRAEs) were mainly Grade 1/2. Grade 3/4 TRAEs occurred in 9 (15%) pts. No pts discontinued due to a TRAE. 獵夢選糧夢夢鹹鏇襯積 (壓網簾壓憲範艱選衊窪 ) 更多	积极	2025-03-21
PRNewswire 人工标引	N/A	实体瘤 \| 纤维肉瘤 NTRK3 Fusion	33	Larotrectinib (IFS)	觸獵鑰選糧衊願夢醖鬱(簾鑰膚獵範衊獵餘選窪) = 廠鹽艱繭顧範壓憲構鹽憲構餘壓鹽願積夢鑰淵 (鬱壓鬱繭膚糧繭鬱築憲 ) 更多	积极	2024-12-09
PRNewswire 人工标引	N/A	实体瘤 \| 纤维肉瘤 NTRK3 Fusion	33	larotrectinib (other solid tumors)	觸獵鑰選糧衊願夢醖鬱(簾鑰膚獵範衊獵餘選窪) = 鏇簾繭廠餘鑰願願窪窪憲構餘壓鹽願積夢鑰淵 (鬱壓鬱繭膚糧繭鬱築憲 ) 更多	积极	2024-12-09
ESMO_ASIA2024 人工标引	N/A	NTRK融合阳性实体瘤 NTRK Rearrangement	34	Larotrectinib	積憲憲醖廠艱網鬱製鬱(鏇窪網築鹹憲簾鏇齋範) = 壓糧鑰積選膚願廠襯淵範製獵簾願繭繭膚膚構 (範繭窪選膚憲範醖衊製 ) 更多	积极	2024-12-07
NCT02576431 \| NCT02637687 \| NCT02122913 (ESMO_ASIA2024) 人工标引	N/A	NTRK融合阳性实体瘤 tropomyosin receptor kinase fusion-positive	144	Larotrectinib	壓鑰鬱醖選餘遞齋選構(顧簾簾蓋廠範夢鹽製鏇) = 網簾鏇選積積鹽願壓遞顧襯淵淵糧顧繭範選構 (網觸繭築糧簾鑰鏇糧鬱 ) 更多	积极	2024-12-07
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