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IIT

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

登录后查看更多信息

100 项与硫酸拉罗替尼相关的转化医学

登录后查看更多信息

100 项与硫酸拉罗替尼相关的专利（医药）

登录后查看更多信息

406

项与硫酸拉罗替尼相关的文献（医药）

2025-04-01·ANNALES D ENDOCRINOLOGIE

Choroidal metastasis secondary to follicular thyroid carcinoma successfully managed with larotrectinib: A case report and review of the literature

Letter

作者: García-Arumí, Claudia ; Bertolani, Yann ; Goncharova, Tetiana ; Arnaiz-Camacho, Albert ; García-Arumí, Jose

2025-01-01·Med

If it is a solid tumor target, then it may be a hematologic cancer target: Bridging the great divide

Review

作者: Adashek, Jacob J ; Munoz, Javier L ; Kurzrock, Razelle

Tumor-agnostic US Food and Drug Administration approvals are transforming oncology. They include larotrectinib/entrectinib/repotrectinib (NTRK fusions), selpercatinib (RET fusions), dabrafenib/trametinib (BRAF^V600E mutations), pembrolizumab/dostarlimab (microsatellite instability), pembrolizumab (high tumor mutational burden), and trastuzumab deruxtecan (HER2 3+ expression) (all solid cancers). Pemigatinib is approved for FGFR1-rearranged myeloid/lymphoid neoplasms. The genomically driven tissue-agnostic approach has a strong biological rationale (cancer is a disease of the genome), yields remarkably high response rates, and provides drug access to patients with an unmet need (rare/ultra-rare malignancies). Despite the solid tumor focus, both solid and hematologic cancers can harbor identical driver molecular abnormalities and respond to cognate therapies. For example, BRAF^V600E and IDH1/2 mutations; ALK, FGFR, and NTRK fusions; PD-L1 amplification; and CD70 antigens are druggable in both solid and blood malignancies by gene-/immune-targeted therapies/chimeric antigen receptor T cells. Future biomarker-based tissue-agnostic basket studies/approvals should bridge the great divide and include both solid and hematologic cancers.

2025-01-01·NEUROPHARMACOLOGY

The engagement of Ras/Raf/MEK/ERK and PLCγ1/PKC pathways regulated by TrkB receptor in resistance of glioma cells to elimination upon apoptosis induction

Article

作者: Rzeski, Wojciech ; Zając, Adrian ; Jakubowicz-Gil, Joanna ; Sumorek-Wiadro, Joanna ; Maciejczyk, Aleksandra ; Wertel, Iwona ; Chojnacki, Michał

The most aggressive tumors of human central nervous system are anaplastic astrocytoma (AA, III grade) and glioblastoma multiforme (GBM, IV grade) with an extremely bad prognosis. Their malignant character and resistance to standard therapy are correlated to the over-expression of survival pathways such as Ras/Raf/MEK/ERK and PLCγ1/PKC regulated by TrkB receptor. Therefore, the aim of this study was to investigate the engagement of those pathways in human glioma cells resistance for apoptosis induction by Temozolomide treatment. Two cancer MOGGCCM (AA) and T98G (GBM) and normal human astrocytes (NHA) cell lines were utilized. The tested inhibitors single and simultaneous action with Temozolomide affection on apoptosis induction was analyzed by MTT, microscopic observations and flow cytometry. Bcl-2:beclin-1 complexes occurrence was also assessed. siRNAs were used for direct proof of tested pathways engagement in gliomas resistance to apoptosis elimination. The most effective in eliminating gliomas with minimal astrocyte damage was 5 μM PLCγ1 inhibitor (U-73122) for MOGGCCM and 15 μM for T98G cells, and 1 μM LOXO-101 for all cancer cells. Sorafenib, Temozolomide, U-73122, and LOXO-101 effectively eliminate cancer cells. Single applications of sorafenib and Temozolomide were effective, but had lower efficiency than U-73122 and LOXO-101. These drugs induced apoptosis, affecting mitochondrial membrane potential and caspases 3, 8, and 9 activity. The study found that a Bcl-2:beclin-1 complex formation was observed when apoptosis was dominant. Inhibiting the pathways regulated by TrkB receptor combined with Temozolomide action, led to successful gliomas elimination. Those results might serve as basis for modern targeted treatment development.

163

项与硫酸拉罗替尼相关的新闻（医药）

2025-01-21

·IQVIA艾昆纬

深度洞察：非小细胞肺癌药物治疗进展与市场趋势

肺癌是全球范围内癌症相关死亡的主要原因1，在中国恶性肿瘤中发病率居首，其中非小细胞肺癌（non-small cell lung cancer, NSCLC）占80%-85%2。NSCLC治疗策略的探索和优化始终是医学肿瘤研究领域的焦点。在NSCLC的早期治疗阶段，手术占主导地位，而药物治疗模式已从传统的含铂化疗为主逐步过渡进展至分子靶向治疗与免疫治疗阶段，同癌异治已成为NSCLC诊疗的主流模式。在晚期NSCLC的全身治疗策略方面，过去十余年间最为关键的突破当属以EGFR、ALK为靶点的分子靶向治疗和PD-(L)1为代表的肿瘤免疫治疗，且相关药物已在临床实践中广泛普及。靶向治疗药物中，EGFR抑制剂药物的研发，大幅提升了晚期NSCLC患者的客观缓解率（overall response rate, ORR）及无进展生存期（progress free survival, PFS）。这些变革不仅彰显了治疗技术的进步，更体现出医学界对该疾病认知的深入演进。同时，其他一些相关靶点的分子靶向药也陆续获批上市，例如ROS1（c-ROS肉瘤致癌因子-受体酪氨酸激酶）、RET（融合基因）、MET（间质-上皮转换因子）、BRAF（V-raf鼠肉瘤病毒癌基因同源体B）、NTRK（神经营养酪氨酸激酶基因的重排），以及KRAS（Kirsten大鼠肉瘤病毒癌基因同源物）、HER2（人表皮生长因子受体-2）等。根据IQVIA Oncology Dynamics(OD)数据库显示，近5年来，肿瘤免疫治疗上升最快，目前份额超过EGFR抑制剂和ALK抑制剂。表皮生长因子受体（EGFR）突变东亚地区肺癌患者中EGFR突变率较其它人种更高，总体达35%3。自2004年于NSCLC中发现EGFR突变起，长达二十年的科学探索与临床研究，为EGFR突变NSCLC的靶向治疗带来了革命性的巨大进步。伴随EGFR-TKI的持续更新迭代，患者的生存期得以显著延长，生活质量亦获得明显改善。 2003年，首个EGFR-TKI吉非替尼获FDA批准。在当时，尚未发现其仅对EGFR敏感突变，后续的一系列研究如IPASS和OPTIMAL研究才接连证实了这一特性。一段时间过后，研究者们留意到EGFR-TKI的耐药问题，继而探寻耐药机制与解决方案。二代EGFR-TKI未能解决耐药的主要根源—T790M突变，直至三代EGFR-TKI奥希替尼的出现，同时以优于一代EGFR-TKI的疗效，并且全面进军一线治疗、术后辅助治疗、III期不可切除放化疗后巩固治疗等多元治疗模式领域。而针对C797S和外显子20插入突变（20ins）等其他耐药机制的其它EGFR相关药物也有在中国上市或处于积极研发进程之中，如已上市的莫博赛替尼，佐利替尼，以及预计2025年Q2上市的埃万妥单抗。根据IQVIA Oncology Dynamics(OD)数据库显示，我们可以看到，随着EGFR-TKI的更新迭代，第一代到第三代EGFR TKI药物使用的市场，相应的变化趋势如下：纵观晚期一线和辅助阶段的EGFR检测率和阳性率的变化趋势，以及整体EGFR TKI使用率的变化，根据下图数据显示，晚期一线病人的EGFR检测率和EGFR TKI的治疗率都达到了一定的程度，术后辅助治疗病人的EGFR检测率和EGFR TKI的治疗率都有较明显的上升趋势。间变性淋巴瘤激酶（ALK）突变 ALK融合作为晚期NSCLC的关键治疗靶点，于2007年被首次发现，在NSCLC患者的发生率为5%-7%4,5。这一突变堪称肺癌靶向治疗领域继EGFR之后的又一重大发现。亚裔、年轻女性以及既往无吸烟史的肺腺癌患者是ALK融合基因阳性突变的主要群体。伴随对ALK通路研究的持续深入，各类ALK抑制剂不断涌现。当前，已有8款ALK-TKI在中国获批，极大地改变了ALK阳性NSCLC患者的治疗局面。第二、三代ALK-TKI能够弥补对第一代ALK靶向药物耐药的不足。针对二代或三代ALK-TKI耐药后的研究正在推进，新的三代、四代药物均已初显成效。根据IQVIA Oncology Dynamics(OD)数据库显示，随着对ALK靶点的重视，ALK的检测率逐步提高，在相应ALK突变人群中的ALK抑制剂的临床应用，也呈现逐步提高的趋势。 ROS1突变 ROS1融合突变发生率在NSCLC患者中约为1.0%6。ROS1与ALK具有显著的序列同源性。ROS1和ALK阳性的NSCLC也具有相似的临床特征，目前大多数可用的ALK抑制剂也靶向ROS1。克唑替尼最初被开发为MET激酶抑制剂，但随后被发现是ALK和ROS1的有效抑制剂。克唑替尼于2017年在中国获批用于治疗ROS1阳性NSCLC。之后其他ROS1抑制剂陆续上市，如恩曲替尼、安奈克替尼和瑞普替尼、他雷替尼。另外还有正处于临床试验的洛拉替尼和伊鲁阿克(两者已在ALK突变获批适应症)。罕见突变靶点RET/MET/BRAF/NTRK/KRAS/HER2 罕见突变靶点药物因基因罕见或研发难度大，目前获批上市的药物不多，RET/MET/BRAF/NTRK/KRAS/HER2突变，相继有对应的药物获批上市。 RET突变 RET融合突变发生率在NSCLC患者中约为1%-2%7。既往使用的药物是多用途多激酶抑制剂，相对活性较低，毒性高。近年来，多种高选择性RET抑制剂研发成功，为RET基因融合的NSCLC患者带来新的希望。目前NMPA批准的药物有普拉替尼和塞普替尼。另外，SY-5007正处于III期临床阶段，用于RET融合晚期NSCLC患者。 MET 14外显子跳跃突变 MET 14外显子跳跃突变在NSCLC患者中的发生率处于0.9%-2.0%8-9。赛沃替尼在2021年6月获得NMPA批准，用于对含铂化疗后疾病进展或者不耐受标准含铂方案化疗且MET基因14号外显子跳跃突变阳性的局部晚期或转移性NSCLC患者进行治疗。之后，谷美替尼、伯瑞替尼、特泊替尼、卡马替尼分别在2023年和2024年相继获NMPA批准，用于MET 14外显子跳跃突变的局部晚期或转移性NSCLC的治疗，使得患者有可选择的针对性治疗方案。 BRAF突变在NSCLC中，BRAF V600突变率处于 1.7%-1.8%10。传统化疗与免疫治疗针对BRAF V600突变人群的疗效欠佳。2022年3月，达拉非尼联合曲美替尼的双靶联合治疗方案获NMPA批准，用于治疗BRAF V600E突变阳性的转移性NSCLC患者，标志着BRAF V600突变的治疗进入了一个新的阶段。在国内2024版CSCO指南里，达拉非尼联合曲美替尼被列为I级推荐，成为标准治疗。恩考芬尼正处于II期临床阶段，联合Binimetinib用于治疗既往未接受过治疗，或曾在转移情况下接受过一次系统性治疗的转移性的BRAF V600E突变型NSCLC患者。HLX208正处于II期临床阶段，单药或联合用于治疗BRAF V600E或BRAF V600突变阳性的晚期实体瘤。 NTRK突变 NTRK融合基因作为NSCLC罕见驱动基因变异类型之一，虽然其在中国肺癌人群中的突变频率极低，大约在0.3%11，近年来的关注度也有提高。在CSCO新版指南里，恩曲替尼、拉罗替尼作为一线治疗的推荐等级由原来的Ⅲ级推荐上调至Ⅰ级推荐。瑞普替尼正处于II期临床阶段，用于携带ROS1、NTRK1、NTRK2和NTRK3重排的NSCLC实体瘤。XZP-5955正处于I/II期临床阶段，拟用于治疗NTRK或ROS1融合和突变的局部晚期/转移性实体瘤。 KRAS G12C突变 KRAS G12C在NSCLC患者中的发生率约为12%12。针对KRAS这一突变靶点，目前全球市场上有两款药物获批，分别是索托拉西布（Sotorasib）和阿达格拉西布（Adagrasib）。目前这两款药均未在国内获批上市，处于III期临床阶段。氟泽雷塞于2024年08月21日获得NMPA批准上市，成为中国首个获批上市的KRAS G12C抑制剂，填补了近40年来这一靶向药领域的空白。2024年11月8日，国内第二个KRAS G12C抑制剂格索雷塞，附条件批准上市。 HER2 对HER2突变NSCLC的患者，以往治疗选择以化疗、免疫治疗及抗血管生成治疗，疗效有限。在NSCLC中的HER2突变率为2%-4%13。随着2024年10月，抗体偶联药物（ADC）德曲妥珠单抗获得NMPA批准，单药用于治疗存在HER2突变，且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性NSCLC成人患者。这是中国首次批准的HER2突变肺癌靶向治疗药物，填补了该领域长期以来的治疗空白，为HER2突变NSCLC患者提供了新的生存希望。瑞康曲妥珠单抗（SHR-A1811）于2024年9月首次申请上市，预记审结日期为2025年8月，用于既往接受过至少一种系统治疗的局部晚期或转移性HER2突变成人NSCLC患者的治疗。2025年1月15日，口服选择性HER2酪氨酸激酶抑制剂-宗格替尼的上市申请，获得NMPA受理，用于成人携带HER2(ERBB2)激活突变且既往接受过系统治疗的不可切除或转移性NSCLC的治疗。BAY 2927088正处于III期临床阶段，用于携带HER2激活突变的局部晚期或转移性NSCLC成人患者。免疫治疗 NSCLC有确切驱动基因时，优先使用靶向治疗药物，针对无驱动基因改变的患者，免疫疗法逐渐成为主要的治疗模式。研究表明，针对PD-(L)1、CTLA-4的靶向治疗具有益处。对于NSCLC患者的免疫疗法包括免疫治疗单药、双免疗法或是免疫联合化疗。免疫单药或联合化疗是非驱动基因和靶向治疗耐药晚期NSCLC一线治疗标准，并且在也在早期的新辅和辅助治疗也有所发展。PD-L1高表达者，免疫加化疗可改善长期生存。PD-L1阴性表达者，双免可以改善长期生长。新的免疫联合策略也正在研究之中。目前国内共有12个PD-(L)1药物有NSCLC适应症。根据OD数据库，我们可以看到在NSCLC一线非驱动基因阳性的患者中，免疫类药物相关的治疗占比增长较快。目前在一线患者中占比超过50%，在辅助治疗中也增长迅速，占比接近25%，方案组合都以免疫联合化疗为主要治疗模式。随着现代医学诊疗手段的不断进步，以及新型疾病相关靶点和机制的发现和研究，不同药物的联合应用为NSCLC的治疗带来了创新。对于个性化治疗，准确的NSCLC亚型分类会越来越重要。动态了解和洞察治疗领域的实时变化，细致反映客观真实世界的数据呈现，也将对企业的产品定位和管线发展布局，提供非常重要的参考价值。 OD数据库与服务介绍 IQVIA肿瘤动态信息数据库(Oncology Dynamics™, OD)是具有代表性且标准化的全球范围的肿瘤数据产品，助力产品全周期价值体现。根据OD数据库，还可以为客户提供定制化的报告。了解不同阶段的药物治疗现状，帮助医疗机构和制药公司更好的优化战略布局，为市场策略和产品优化提供有力支持。参考文献 1. Leiter, A., Veluswamy, R.R. & Wisnivesky, J.P. The global burden of lung cancer: current status and future trends. Nat Rev Clin Oncol 20, 624–639 (2023). 2. 中国抗癌协会肺癌专业委员会，中国胸部肿瘤研究协作组，中华医学会肿瘤学分会肺癌专家委员会.非小细胞肺癌围术期免疫治疗的共识与争议（2024版）[J]. 中华肿瘤杂志，2024, 46(12): 1107-1126. 3. Gold, Kathryn A. et al. FDG-PET/CT as a Predictor of Outcome in EGFR-Mutant Non–Small-Cell Lung Cancer.Journal of Thoracic Oncology, Volume 10, Issue 8, 1131 - 1132 4. Hirsch FR, Scagliotti GV, Mulshine JL, et al. Lung cancer: Current therapies and new targeted treatments Lancet 389299–3112017 5. Barlesi F, Mazieres J, Merlio JP, et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: Results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT) Lancet 3871415–14262016 6. Glaser, M. et al. 1374P Survival and therapy analysis of small-scale ROS1-mutant non-small cell lung cancer (NSCLC) patients. Annals of Oncology, Volume 34, S789 7. Drilon A, Oxnard GR, Tan DSW, Loong HHF, Johnson M, Gainor J, McCoach CE, Gautschi O, Besse B, Cho BC, Peled N, Weiss J, Kim YJ, Ohe Y, Nishio M, Park K, Patel J, Seto T, Sakamoto T, Rosen E, Shah MH, Barlesi F, Cassier PA, Bazhenova L, De Braud F, Garralda E, Velcheti V, Satouchi M, Ohashi K, Pennell NA, Reckamp KL, Dy GK, Wolf J, Solomon B, Falchook G, Ebata K, Nguyen M, Nair B, Zhu EY, Yang L, Huang X, Olek E, Rothenberg SM, Goto K, Subbiah V. Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Aug 27;383(9):813-824. 8. Liu SY, Gou LY, Li AN, Lou NN, Gao HF, Su J, Yang JJ, Zhang XC, Shao Y, Dong ZY, Zhou Q, Zhong WZ, Wu YL. The Unique Characteristics of MET Exon 14 Mutation in Chinese Patients with NSCLC. J Thorac Oncol. 2016 Sep;11(9):1503-10. 9. Qiu T, Li W, Zhang T, Xing P, Huang W, Wang B, Chu L, Guo L, Liu X, Li Y, Ying J, Li J. Distinct MET Protein Localization Associated With MET Exon 14 Mutation Types in Patients With Non-small-cell Lung Cancer. Clin Lung Cancer. 2018 Jul;19(4):e391-e398. 10. Fan, Y. et al. EP08.02-052 Safety and Efficacy of Dabrafenib Plus Trametinib in Chinese Patients With BRAF V600E- Mutation Positive Metastatic NSCLC. Journal of Thoracic Oncology, Volume 17, Issue 9, S423 11. Ling, Q. et al. The landscape of NTRK fusions in Chinese patients with solid tumor. Annals of Oncology, Volume 29, viii22 - viii23 12. Kempf E, Rousseau B, Besse B, Paz-Ares L. KRAS oncogene in lung cancer: focus on molecularly driven clinical trials. Eur Respir Rev. 2016 Mar;25(139):71-6. 13. Frans Opdam, et al. 2024 WCLC. MA12.10. 数据库详情，敬请垂询： Mark Liao IQVIA艾昆纬高级执行总监、中国肿瘤领域解决方案负责人 yuan.liao@iqvia.com Jessica Yang IQVIA艾昆纬肿瘤动态数据库产品经理 jessica.yang2@iqvia.com 声明原创内容的最终解释权以及版权归IQVIA艾昆纬中国所有。如需转载文章，请发送邮件至iqviagcmarketing@iqvia.com。

免疫疗法临床3期上市批准临床结果CSCO会议

2025-01-09

·蒲公英Ouryao

参比制剂目录（第89批）正式发布！

转自：国家药监局编辑：随风 2025年01月08日，国家药监局发布了第89批次仿制药一致性评价参比制剂目录，其中新增品种51个。通知原文经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第八十九批）。新增品种：丁甘交联玻璃酸钠注射液、硫酸拉罗替尼胶囊、替尔泊肽注射液、环磷酰胺注射液、多西环素干混悬剂、盐酸哌甲酯缓释胶囊、多西他赛注射液（磺丁基-β-环糊精驱动型）、低钙腹膜透析液（乳酸盐-G4.25%）、盐酸曲马多缓释胶囊、亚硒酸钠注射液、唑尼沙胺口崩片、唑尼沙胺散、佩玛贝特缓释片、双氯芬酸钠滴眼液等；仿制药参比制剂目录（第89批）

一致性评价

2025-01-02

·GlobeNewswire-Health Care

Bionano Announces Publication from Johns Hopkins School of Medicine Showing that OGM Outperformed Multiple Cytogenetic Assays in a Study of Bone and Soft Tissue Tumor Analysis

In the largest study to date of bone and soft tissue tumors, OGM detected 100% of the variants found by multiple standard techniques, including karyotyping, fluorescent in-situ hybridization (FISH) & gene fusion assays OGM was also more sensitive, including detection of diagnostic or pathogenic variants missed by karyotype in 74% (14/19) of cases that failed or were negative by karyotyping When OGM results and next-generation sequencing (NGS) results were combined, diagnostic and pathogenic structural variants (SVs), copy number variants (CNVs), and/or single nucleotide variants (SNVs) were found in ~98% of cases, a substantially greater rate than when karyotyping, FISH and NGS are used Dec. 23, 2024 -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced a publication in Modern Pathology by a group of researchers at the Johns Hopkins University School of Medicine, showing that optical genome mapping (OGM) can outperform traditional techniques in analysis of bone and soft tissue tumors. Several prior publications have shown the utility of OGM compared to traditional cytogenetics in studies of hematologic malignancies, however, data on the application of OGM in solid tumors has been relatively sparse. This study provides compelling support for extending the utility of OGM in cancer beyond hematologic malignancies to solid tumors. OGM detected all variants revealed by conventional cytogenetics: OGM showed 100% concordance, identifying all pathogenic variants detected by standard of care cytogenetic methods. The specificity of OGM was assessed to be 100%, i.e. OGM correctly identified the same pathogenic SVs and CNVs detected by standard of care/routine cytogenetics (karyotyping and FISH). OGM detected pathogenic variants missed by karyotyping: In 74% of cases with normal or failed karyotype, OGM detected diagnostic or pathogenic SVs that were missed by karyotyping. Further, in 6 cases that failed to yield any karyotyping results due to culture failure, OGM detected pathogenic SVs in all of them. Variants found by OGM but missed by standard of care included the EWSR1::ETV1 fusion, which is a key molecular hallmark of clear cell sarcoma and helps to differentiate it from other soft tissue sarcomas and melanomas. OGM resolved complex cancer genomes: Study authors found that OGM data could re-characterized and better defined complex structural rearrangements including chromoanagenesis in 27% of cases and complex 3-6-way translocations in 15% of cases when compared to traditional cytogenetic methods. OGM combined with NGS found pathogenic variants in 98% of cases, a substantially greater rate than when karyotyping, FISH and NGS are used: The integrated approach of the combination of OGM and NGS resulted in the detection of pathogenic SVs and sequence variants in ~98% of cases. OGM was 100% concordant with NGS for aneuploidy detection. OGM findings have the potential to qualify subjects for targeted therapies that otherwise would not have been possible: The authors state that several of the OGM findings could result in the potential for these cases to qualify for either targeted treatments or clinical trials. For example, cases with potential to be treated by CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib), TRK inhibitors (larotrectinib, entrectinib), pan-FGFR inhibitors (erdafitinib or futibatinib) were highlighted. Erik Holmlin, president and chief executive officer of Bionano commented, “Approximately 50% of bone and soft tissue tumor samples fail to reveal actionable information for proper classification of disease, prognosis and therapeutic management because they either fail to culture or because traditional techniques in cytogenetics lack adequate sensitivity and specificity to reliably detect relevant variants. We have seen increasing evidence for OGM as a valuable alternative to cytogenetic methods in blood cancers, and we are thrilled to see researchers at Johns Hopkins publishing this compelling case for extending OGM’s utility to bone and soft tissue tumors.” The full research publication is available at: https://doi-org.libproxy1.nus.edu.sg/10.1016/j.modpat.2024.100684 Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services. The content above comes from the network. if any infringement, please contact us to modify.

寡核苷酸

100 项与硫酸拉罗替尼相关的药物交易

登录后查看更多信息

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,

后查看更多信息

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
NTRK融合阳性实体瘤	欧盟	Bayer AG	2019-09-19
NTRK融合阳性实体瘤	冰岛	Bayer AG	2019-09-19
NTRK融合阳性实体瘤	列支敦士登	Bayer AG	2019-09-19
NTRK融合阳性实体瘤	挪威	Bayer AG	2019-09-19
肿瘤	加拿大	Bayer, Inc.	2019-07-10
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
晚期恶性实体瘤	临床2期	美国	Bayer AG	2015-09-30
晚期恶性实体瘤	临床2期	中国	Bayer AG	2015-09-30
晚期恶性实体瘤	临床2期	日本	Bayer AG	2015-09-30
晚期恶性实体瘤	临床2期	阿根廷	Bayer AG	2015-09-30
晚期恶性实体瘤	临床2期	澳大利亚	Bayer AG	2015-09-30
晚期恶性实体瘤	临床2期	比利时	Bayer AG	2015-09-30
晚期恶性实体瘤	临床2期	巴西	Bayer AG	2015-09-30
晚期恶性实体瘤	临床2期	加拿大	Bayer AG	2015-09-30
晚期恶性实体瘤	临床2期	哥伦比亚	Bayer AG	2015-09-30

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


PRNewswire 人工标引	N/A	实体瘤 \| 纤维肉瘤 NTRK3 Fusion	33	Larotrectinib (IFS)	製淵憲顧壓窪製願鬱顧(鑰鏇鹽襯窪構願糧淵齋) = 選窪糧製製鬱選廠窪築獵醖築範鏇醖餘顧夢簾 (觸淵壓淵餘簾簾網願選 ) 更多	积极	2024-12-09
				larotrectinib (other solid tumors)	製淵憲顧壓窪製願鬱顧(鑰鏇鹽襯窪構願糧淵齋) = 網獵顧觸餘鹽願簾構窪獵醖築範鏇醖餘顧夢簾 (觸淵壓淵餘簾簾網願選 ) 更多
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	鹹齋構製衊夢構壓淵構(憲積鏇鏇廠積糧醖築壓) = 鹽窪獵廠遞糧範繭製膚襯顧襯艱積夢遞選範繭 (夢網窪願築觸積壓糧齋 ) 更多	积极	2024-12-07
				Standard of Care (SoC)	鹹齋構製衊夢構壓淵構(憲積鏇鏇廠積糧醖築壓) = 簾壓鹽壓醖艱遞膚齋繭襯顧襯艱積夢遞選範繭 (夢網窪願築觸積壓糧齋 ) 更多
ESMO_ASIA2024 人工标引	N/A	NTRK融合阳性实体瘤 NTRK Rearrangement	34	Larotrectinib	簾夢廠窪獵廠襯鹹膚鏇(壓窪鏇範憲醖築繭蓋鏇) = 築憲憲遞窪襯鹹窪網獵獵壓襯鬱鹽窪餘顧廠壓 (壓願鹽觸壓淵繭鬱製艱 ) 更多	积极	2024-12-07
NCT02576431 \| NCT02637687 (CTNI-07, SNO2024)	N/A	NTRK融合基因阳性的中枢神经系统肿瘤	55	Larotrectinib	遞艱鬱網遞襯鏇觸鹹廠(廠襯蓋壓獵獵範廠繭窪) = 鑰觸網醖獵觸餘繭餘窪醖醖醖觸繭醖窪選窪願 (廠積淵夢製鹽襯顧範淵 ) 更多	积极	2024-11-11
ESMO2024 人工标引	N/A	复发性胶质母细胞瘤 BRAF V600E	17	Dabrafenib-trametinib	襯網繭顧鬱壓積遞糧廠(鏇鬱顧淵糧憲膚築壓糧) = None 獵鏇艱選鹹醖鬱壓願糧 (夢遞鑰鹽願鏇獵餘膚鹹 )	积极	2024-09-16
				Larotrectinib
NCT02576431 \| NCT02637687 \| NCT02122913 (SCOUT, ESMO2024) 人工标引	临床1/2期	中枢神经系统肿瘤 NTRK gene fusions	302	Larotrectinib	構蓋構壓積鬱積齋築觸(鹹顧餘蓋製齋齋繭鏇醖) = 繭鹽廠廠蓋憲鏇醖鑰窪餘鹹鏇積衊蓋構築製餘 (憲夢鏇繭顧範製鏇積糧, 59 ~ 70) 更多	积极	2024-09-14
NCT02576431 \| NCT02637687 \| NCT02122913 (SCOUT, ESMO2024) 人工标引	临床1/2期	肿瘤一线 NTRK gene fusions	100	Larotrectinib	襯範繭廠遞鑰顧積壓網(觸願觸壓積構襯蓋衊獵) = 齋選鹽簾獵膚鏇糧襯餘窪顧鏇鏇壓獵鹹鑰淵醖 (觸顧夢積蓋網壓積衊繭, 65 ~ 86) 更多	积极	2024-09-14
				Larotrectinib (adults)	顧製築網艱膚壓襯繭廠(鹽廠獵鹽壓壓憲艱鬱鑰) = 築糧壓觸憲繭醖壓窪憲蓋鹹繭醖淵獵膚糧顧艱 (夢齋憲窪壓選遞齋衊鑰, 54 ~ 79)
NCT02576431 \| NCT02122913 (WCLC2024) 人工标引	临床1/2期	肺癌 NTRK Rearrangement	32	Larotrectinib 100 mg	觸夢顧艱膚獵衊選蓋構(衊夢鬱鹽齋膚顧醖積壓) = 夢顧艱構鏇衊糧鹽憲築範網壓構夢繭齋積觸構 (蓋鬱夢齋製餘範膚鑰顧 ) 更多	积极	2024-09-10
NCT05192642 (VICTORIA, ASCO2024) 人工标引	N/A	肿瘤 TRK fusion	164	Larotrectinib	網襯憲製選觸鏇襯鑰範(壓簾鬱齋淵糧積觸願膚) = 築構製鹹鹽淵顧積鏇觸願選鏇鏇廠淵淵艱夢淵 (糧構網積願蓋繭窪餘範 ) 更多	积极	2024-05-24
				Non-TRK inhibitor therapies	網襯憲製選觸鏇襯鑰範(壓簾鬱齋淵糧積觸願膚) = 範繭網淵獵網鬱遞鹽積願選鏇鏇廠淵淵艱夢淵 (糧構網積願蓋繭窪餘範 ) 更多
NCT02576431 \| NCT02122913 (ASCO2024) 人工标引	临床1/2期	肺癌 TRK fusion	32	Larotrectinib 100 mg	鏇積顧範衊鑰蓋網膚鹹(網積願構糧獵獵艱齋淵) = Treatment-related adverse events (TRAEs) were predominantly Grade 1/2. 蓋遞艱鏇簾衊廠範網繭 (醖淵鑰醖艱醖鹹衊製繭 )	积极	2024-05-24