Addition of postoperative chemotherapy to prevent or delay recurrence in patients newly diagnosed with localized uterine leiomyosarcoma and who have undergone complete tumor surgery.

开始日期2025-02-01

申办/合作机构

UNICANCER

[+5]

NCT06050434

/ CompletedN/AIIT

PROTraSarc Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients - A GISAR Sub-study

Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. The prospective study will primarily investigate the PRO of Trabectedin rechallenge in patients with soft tissue sarcomas that had to discontinue initial Trabectedin treatment due to various reasons such as progression, side effects or surgery, as is commonly the case in real-life settings. Embedding this trial in the GISAR registry enables the evaluation of a large number of patients with long-term follow-up which allows multiple analyses regarding different questions that remain unanswered until today.

开始日期2023-10-31

申办/合作机构

Institut fr Klinische Krebsforschung IKF GmbH

[+1]

NCT04794127

/ Recruiting临床2期IIT

A Phase II Study on Trabectedin in Combination With PPARg Agonist Pioglitazone in Patients With Round Cell Myxoid Liposarcomas or Dedifferentiated G1 and G2 Liposarcomas With Stable Disease After a Monotherapy With Trabectedin. (TRABEPIO)

This is a phase 2 study conducted in two sequential stages:
The first stage is an Italian single institution, single arm, pilot study, aimed at exploring the activity of the combination T and P in myxoid liposarcoma patients who achieved a stable disease after a minimum of 4 cycles of T alone. If a minimum required activity will be demonstrated from the first stage, the second stage of the study will be conducted;otherwise, the study will be stopped. The second stage is an Italian open-label, multicenter, randomized, double arm, phase II trial, aimed at evaluating the combination of T and P in myxoid liposarcoma and G1 or G2 dedifferentiated liposarcomas compared to the standard treatment with T alone. Patients will be randomized with a 1:1 ratio to treatments arms as specified below:
Control arm (A): T alone
Experimental arm (B): T in combination with P

开始日期2022-02-02

申办/合作机构

Fondazione Irccs Istituto Nazionale Dei Tumori

[+1]

100 项与曲贝替定相关的临床结果

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100 项与曲贝替定相关的转化医学

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100 项与曲贝替定相关的专利（医药）

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1,449

项与曲贝替定相关的文献（医药）

2025-03-01·Annals of Surgical Oncology

Sarcoma: Last Year’s Practice Changing Papers

Review

作者: Gronchi, Alessandro ; van Houdt, Winan J

BACKGROUNDIn 2023 and 2024, a wide variety of new studies have been published in the field of soft tissue sarcomas, representing the enormous heterogeneity of sarcoma histotypes, anatomical location, treatment variability, and biological behavior.PATIENTS AND METHODSThis article summarizes the, in our view, seven most important publications in the field that will have an impact on the surgical practice and future treatment strategies of our patients.RESULTSIn the last year, we gained more insight in the genetic background of patients with sarcoma from a large Australian study, which will have an impact on future counseling and screening of our patients. Also, the role of radiotherapy in retroperitoneal liposarcoma became clearer in the combined STRASS-STREXIT study. Radiotherapy for extremity sarcomas can now also be done in a 3-week, hypofractioned manner, which is a major improvement for our patients. Furthermore, more evidence has been presented regarding the improved outcome of patients with retroperitoneal sarcoma when treated in high volume centers. Landmark studies with systemic treatment include the positive trial with nirogacestat in desmoid tumors, which have finally shifted the paradigm of desmoid treatment from surgery to systemic treatment. Also, the results of 2 phase 3 randomized controlled trials recently showed 1) that the combination of doxorubicin with trabectedin significantly improved progression free survival for patients with leiomyosarcoma when compared with doxorubicin alone and 2) that the combination of neoadjuvant pembrolizumab and radiotherapy followed by 1-yr adjuvant pembrolizumab significantly improved disease free survival for patients with primary localized undifferentiated pleomorphic sarcoma/myxofibrosarcoma or dedifferentiated/pleomorphic liposarcoma of the extremities or girdles.CONCLUSIONSKey papers from the last year informs us that management of soft tissues sarcoma is constantly improving, since more data became available to guide us in defining the best treatment strategies.

2025-03-01·In Vivo

HT1080 Fibrosarcoma With Acquired Trabectedin Resistance: Increased Malignancy But Sustained Sensitivity to Methionine Restriction

Article

作者: Han, Qinghong ; Hayashi, Katsuhiro ; Tsuchiya, Hiroyuki ; Morinaga, Sei ; Kimura, Hiroaki ; Igarashi, Kentaro ; Kang, Byung Mo ; Hoffman, Robert M ; Higuchi, Takashi ; Bouvet, Michael ; Mizuta, Kohei ; Miwa, Shinji ; Yamamoto, Norio ; Demura, Satoru

BACKGROUND/AIMTrabectedin is a DNA-binding agent that has shown moderate efficacy for soft-tissue sarcomas. We have previously shown that methionine restriction enhances trabectedin efficacy on both parental and trabectedin-resistant HT1080 (TR-HT1080) cells in vitro The aim of the present study was to determine whether fibrosarcoma cells that acquire trabectedin resistance become more malignant but maintain sensitivity to methionine restriction in vivoMaterials and Methods: TR-HT1080 was established by culturing HT1080 cells in stepwise increasing concentrations of trabectedin. An in vitro wound-healing invasion assay was used to compare malignancy of HT1080 and TR-HT1080. In vivo, six groups were established: G1-G4 (TR-HT1080): G1, untreated control; G2, trabectedin treatment; G3, methionine-restricted diet; G4, methionine-restricted diet combined with trabectedin; G5, untreated control of parental HT1080; and G6, trabectedin treatment of parental HT1080.RESULTSThe IC₅₀ of trabectedin was previously determined to be 3.3 nM for the parental HT1080 cells and 42.9 nM for trabectedin-resistant HT1080 cells, representing a 13-fold increase. Wound-healing invasion assays in vitro showed a more rapid wound-closure ratio in TR-HT1080 cells than in parental cells, suggesting increased malignancy compared to the parental cells. The volume of untreated TR-HT1080 tumors grew more rapidly than that of HT1080 tumors, indicating a higher malignancy of TR-HT1080 tumors. The IC₅₀ of recombinant methioninase was previously determined as 0.75 U/ml for HT1080 and 0.93 U/ml for TR-HT1080 cells. Methionine restriction was highly effective on TR-HT1080 tumors, decreasing tumor growth by 4-fold.CONCLUSIONTR-HT1080 cells acquired high malignancy by in vitro selection for trabectedin resistance. However, methionine restriction overcame trabectedin resistance in vivo, strongly inhibiting tumor growth, which should be further investigated in the clinic.

2025-02-01·Japanese Journal of Radiology

Evaluation of a novel central venous access port for direct catheter insertion without a peel-away sheath

Article

作者: Tomita, Koji ; Uka, Mayu ; Okamoto, Soichiro ; Iguchi, Toshihiro ; Matsui, Yusuke ; Kawabata, Takahiro ; Hiraki, Takao ; Munetomo, Kazuaki ; Umakoshi, Noriyuki

AbstractPurposeThis study retrospectively evaluated the feasibility and safety of implanting a newly developed central venous access port (CV-port) that allows catheter insertion into a vein without the use of a peel-away sheath, with a focus on its potential to minimize risks associated with conventional implantation methods.Materials and methodsAll procedures were performed using a new device (P-U CelSite Port™ MS; Toray Medical, Tokyo, Japan) under ultrasound guidance. The primary endpoint was the implantation success rate. The secondary endpoints were the safety and risk factors for infection in the early postprocedural period (< 30 days).ResultsWe assessed 523 CV-port implantations performed in a cumulative total of 523 patients (240 men and 283 women; mean age, 61.6 ± 13.1 years; range, 18–85 years). All implantations were successfully performed using an inner guide tube and over-the-wire technique through 522 internal jugular veins and one subclavian vein. The mean procedural time was 33.2 ± 10.9 min (range 15–112 min). Air embolism, rupture/perforation of the superior vena cava, or hemothorax did not occur during catheter insertion. Eleven (2.1%) intraprocedural complications occurred, including Grade I arrhythmia (n = 8) and subcutaneous bleeding (n = 1), Grade II arrhythmia (n = 1), and Grade IIIa pneumothorax (n = 1). Furthermore, 496 patients were followed up for ≥ 30 days. Six early postprocedural complications were encountered (1.1%), including Grade IIIa infection (n = 4), catheter occlusion (n = 1), and skin necrosis due to subcutaneous leakage of trabectedin (n = 1). These six CV-ports were withdrawn, and no significant risk factors for infection in the early postprocedural period were identified.ConclusionThe implantation of this CV-port device demonstrated comparable success and complication rates to conventional devices, with the added potential benefit of eliminating complications associated with the use of a peel-away sheath.

项与曲贝替定相关的新闻（医药）

2025-03-04

·蒲公英Ouryao

Paul's Insight｜解读国际法规药事(02.24-03.02)

◆ ◆ ◆ ◆ Paul's Insight 2025年2月24日-3月2日 ◆ ◆ ◆ ◆ 随着全球医药行业的持续进步，各国药品监管机构和制药公司在推进创新药物的审批、上市和安全管理方面不断加速步伐。本期动态（2月24日至3月2日）涵盖了美国FDA、欧洲EMA以及其他机构，从药品上市、安全风险和监管创新等各个方面，反映出全球药事新闻中的多样性与紧迫感。让我们一起走进这一波全球药事新闻，看看各大药品监管机构如何推动药品安全与疗效的平衡，同时，行业协会的新思考也让我们对未来医药行业的变革与发展有更多期待。美国FDA 新药物审批与安全管理的双重进步 1. FDA批准Odactra扩展适应症：为儿童群体带来新希望美国FDA最近批准了屋尘螨过敏药片Odactra的适应症扩展，使其适用于5-11岁的儿童群体。之前，该药物仅获得批准用于12-65岁人群，用于治疗由屋尘螨过敏引发的过敏性鼻炎（无论是否伴随结膜炎）。图：FDA批准了屋尘螨过敏药片Odactra的适应症扩展据统计，全球约有超过千万5至11岁儿童受到屋尘螨过敏的困扰，而屋尘螨是引发过敏性鼻炎和哮喘的重要原因之一。通过FDA的批准，更多孩子将能够获得这款药物的治疗，减轻呼吸道过敏症状，提升生活质量。图：全球约有超过千万5至11岁儿童受到屋尘螨过敏的困扰（参考：https://www.fda.gov/news-events/press-announcements/fda-roundup-february-28-2025） 2. 睾酮产品标签更新：确保药物使用更安全另一项关键决策是，FDA对所有睾酮产品生产商发布了新的标签更新要求，要求将TRAVERSE临床试验和血压监测（ABPM）研究结果纳入标签。TRAVERSE试验是一项评估睾酮替代疗法对性腺功能低下男性主要心血管不良事件发生率和疗效措施影响的研究。图：FDA对所有睾酮产品生产商发布了新的标签更新要求这一变化的核心在于，在所有睾酮产品标签上添加TRAVERSE试验数据，明确指出试验对年龄相关性低睾酮治疗的安全性结论。此外，FDA还保留了年龄相关性低睾酮适应症说明，以确保临床医生和患者正确理解药物的适用范围。同时，FDA更新了标签中的心血管风险警示语，以反映最新的临床证据。这项更新不仅传递了精准的药品疗效信息，也有助于减少不必要的恐慌，促进安全合理的用药实践，确保患者在获得疗效的同时降低潜在的健康风险。图：新英格兰医学杂志发表TRAVERSE试验结果，成为FDA的重要参考（参考：https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products） 3. FDA紧急召回通知：药品安全第一在药品召回方面，FDA近期发布了针对一家药房配药设施（CAPS）生产的苯肾上腺素注射剂的紧急召回通知。部分批次产品被检测出含有黑色颗粒，可能源自原料供应链问题。含有颗粒的注射药物可能引发局部刺激、血管堵塞，甚至导致心脏、肺部或脑部血管阻塞，带来严重的健康风险。此次召回涉及多个批次，已经通知相关经销商和医院，要求医护人员和患者立即停止使用，并按照规定进行退货或销毁处理。作为一家配药药房，CAPS的经营类似于药品生产商，但这些配药药房并未向联邦政府注册或遵守同样的安全法律。历史上，新英格兰配药中心出产的受污染醋酸甲级强的松龙（Methylprednisolone acetate），共造成47例死亡，660例患病，酿成美国历史上最严重的药品灾难之一。图：一家药房配药设施生产的苯肾上腺素注射剂被紧急召回（参考：https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/central-admixture-pharmacy-services-caps-issues-nationwide-recall-phenylephrine-40-mg-added-09） 4. 谷歌智能手表“失脉检测”功能获FDA批准：技术创新为健康加分此外，FDA还批准了谷歌智能手表的关键功能“失脉检测”在美国市场的上线。该功能能够在用户心跳骤停时自动触发报警并呼叫紧急救援，之前该功能已经在欧洲市场推广，但因美国的监管要求一直未能开放。通过结合光学心率传感器、红外传感器和运动传感器，该功能不仅能够检测心跳停止，还能够进行二次确认，提高报警准确性。FDA认为，这项功能可挽救生命，特别适用于独居或行动不便的高风险人群。这项批准标志着医疗器械和消费电子产品在健康监测领域的逐步融合，也为未来健康管理技术的发展铺平了道路。图：谷歌智能手表“失脉检测”功能获FDA批准（参考：https://pharmaphorum.com/news/fda-clears-lifesaving-feature-googles-pixel-watch-3）美国PDA 助力药品安全性与合规性提升 2月26日，美国注射剂协会（PDA）发布了最新的《制药行业质量文化评估指南》，该指南提出了五大核心主题：领导承诺、沟通与协作、员工参与、持续改进和技术卓越。指南的发布不仅帮助制药企业评估现有质量文化，还确保企业与监管机构的期望一致，为全球药品的安全性和合规性提供了重要参考。图：PDA发布质量文化评估指南（参考：https://www.pda.org/about-pda/press-releases/press-release-detail/just-released-pda-ansi-standard-06-2025-quality-culture-assessment-of-quality-culture-guidance-documents-models-and-tools）欧洲EMA 药品创新加速，监管更加高效 1. 上市后变更试点计划：提升药品审批效率在欧洲，欧洲药品管理局（EMA）也在近期推出了一项重要举措——“依托应用：上市后变更试点计划”。该计划的目的是加速药品上市后变更的审批流程，使制药企业在调整药品质量、生产工艺或配方时能够借助已认可的监管评估数据，减少重复审查，从而加快审批进程。这一举措不仅提高了监管效率，还促进了跨国监管合作与经验共享，为全球药品的创新和上市提供了更为高效的监管支持。图：EMA发布试点计划，促进了跨国监管合作与经验共享（参考：https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/reliance-applied-post-autorisation-changes-pilots-pharmaceutical-industry） 2. CHMP会议亮点：新药上市推荐在EMA的人用药品委员会（CHMP）会议上，CHMP推荐了四种新药的上市申请，其中包括全球首个外用基因治疗产品——Vyjuvek，这款药物是为了治疗营养不良性大疱性表皮松解症而开发的。 Vyjuvek作为全球首个外用基因治疗产品，得到了EMA的优先药物（PRIME）计划支持，为罕见遗传性皮肤病患者带来了新的治疗希望。此外，Deqsiga（用于免疫缺陷患者的免疫球蛋白）、Lynozyfic（用于复发性多发性骨髓瘤的治疗）以及Trabectedin Accord（用于晚期软组织肉瘤和复发性卵巢癌的仿制药）也都获得了EMA的推荐，为患者提供了更多的治疗选择。图：Vyjuvek为全球首个外用基因治疗产品（参考：https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-february-2025）英国MHRA 为老年人健康护航在英国，英国药品和健康产品管理局（MHRA）近期批准了Moderna公司研发的mRESVIA mRNA疫苗。该疫苗旨在为60岁及以上人群预防呼吸道合胞病毒（RSV）感染。RSV是一种严重的呼吸道病毒，每年会导致全球超过17万名60岁以上老人住院，并造成1.4万例死亡。图：英国MHRA批准了Moderna公司研发的mRESVIA mRNA疫苗 mRESVIA是一款针对RSV的mRNA疫苗，由编码稳定融合前F糖蛋白的mRNA序列组成。其与2024年5月获得美国FDA批准，是Moderna公司第二项获批的mRNA疫苗。mRESVIA的临床试验数据显示，接种疫苗约 4 个月后，与接种安慰剂的人相比，接种 RSV疫苗的人患RSV引起的下呼吸道疾病的风险降低了 79%，为高风险老年群体带来了极大的福音。MHRA的批准标志着mRNA技术在疫苗领域的再次成功应用。图：RSV 疫苗为高风险老年群体带来了极大的福音（参考：https://www.gov.uk/government/news/mresvia-rsv-vaccine-approved-to-protect-patients-aged-60-and-over） ICH 加强临床试验监管日前，国际人用药品注册技术协调会（ICH）发布了《药物临床试验管理规范》（GCP）修订版的官方培训材料，讲解了ICH E6(R3)的修订、结果和变化内容。这一新指南强调了基于风险管理的临床试验设计，推动数据共享和国际协调，鼓励“以患者为中心”的试验模式。图：ICH发布 E6(R3)修订版的官方培训材料（参考：https://www.ich.org/news/ich-e6r3-introductory-training-presentation-now-available-ich-website） ISPE 无菌生产数据管理要求 ISPE最新文章强调数据管理在无菌药品生产中的关键作用，特别是在欧盟GMP附录1修订版发布后。文章指出，数据管理不仅对于验证和风险管理至关重要，还涉及到ALCOA++原则的具体应用，以确保数据的完整性和可靠性。文章强调了数据生命周期管理的重要性，并提出了确保无菌生产过程中数据准确性的一些最佳实践。图：ISPE最新文章强调数据管理在无菌药品生产中的关键作用（参考: https://ispe.org/pharmaceutical-engineering/ispeak/data-management-requirements-sterile-manufacturing）结语药品安全与创新的双重驱动从FDA到EMA，再到MHRA、ICH，我们看到全球药品监管机构在不断推动药品审批效率的同时，确保药品的安全性与有效性。在技术的不断进步和全球合作的加强下，创新药物和健康管理工具正迅速走向市场。无论是新药的上市、临床试验的规范，还是质量管理的提升，全球药事领域正朝着更加高效、透明和创新的方向发展。我们有理由相信，未来药品监管和创新将继续携手并进，为全球公众的健康保驾护航。 END 声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。 2024生物行业年度总结 ● 2024年中国生物行业主要政策回顾与盘点 ● 回顾展望生物医药：2024深度转型，2025破冰发展 ● 2024年生物医药产业政策盘点（附政策包下载） ● 生物医药产教融合：推动产业可持续发展的关键路径 ● 从"卡脖子"到"自主可控":生物医药供应链国产替代进行时 ● 生物制品抗体行业的2024 ● 7大亮点回顾2024全球ADC产业图景 ● 细胞治疗2024：盘点行业的破局之道 ● 开启生命科学新纪元：2024基因治疗全景复盘

临床研究申请上市医药出海

2025-02-28

·FiercePharma

Eisai, Biogen's Leqembi emerges from safety reappraisal unscathed as Europe's CHMP endorses slate of new drugs and label expansions

For Eisai and Biogen, the European Medicines Agency’s Committee for Medicinal Products for Human Use’s decision to stick by its previous call on Leqembi now punts the final approval verdict back to the European Commission, which is the ultimate authority on whether a drug scores marketing authorization in the EU. Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), drugmakers are celebrating a bevy of endorsements for big-name meds.Over the course of the sit-down, which ran from Monday through Thursday, the CHMP recommended four new drugs for approval, teed up another 16 potential label expansions and—in a major win for Eisai and Biogen—reaffirmed the positive opinion on the Alzheimer’s disease drug Leqembi (lecanemab) it first issued in November, according to the agency’s meeting summary Friday.For Eisai and Biogen, the CHMP’s decision to stick by its previous call now punts the final approval verdict for Leqembi back to the European Commission (EC), which is the ultimate authority on whether a drug scores marketing authorization in the EU.Despite Leqembi winning the CHMP’s favor in November—albeit in a somewhat restricted patient population—the European regulator last month said it would honor the EC’s request to consider new safety data on the antibody that surfaced after the initial thumbs-up, Biogen explained in a Friday press release.“The safety profile of lecanemab reported in clinical practice in the United States, Japan and other countries after launch is consistent with that in the approved labels, and no new safety signals are identified,” Biogen said of the situation last month. The CHMP has specifically backed Leqembi to treat mild cognitive impairment or mild dementia from Alzheimer’s but only for patients carrying one or no copy of the ApoE4 gene. Patients with two copies of the gene are at greater risk of brain swelling or bleeding side effects known as amyloid-related imaging abnormalities, according to trial data. Elsewhere, the CHMP this week advanced four new drugs for potential European approvals. Those are: Takeda’s immunoglobulin drug Deqsiga, Regeneron’s multiple myeloma antibody Lynozyfic, Krystal Biotech’s dystrophic epidermolysis bullosa gene therapy Vyjuvek and Accord Healthcare’s generic drug trabectedin, which has been endorsed in advanced soft tissue sarcoma and relapsed platinum-sensitive ovarian cancer.As for proposed label expansions, the CHMP endorsed new uses for drugs from Vertex, Novartis, AbbVie, Eli Lilly and many other companies.In Lilly’s case, the regulator recommended approval for the company’s BTK inhibitor Jaypirca to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL) who’ve already tried another medication from the same class.In addition to the new positive opinion in CLL, the drug also boasts a conditional European nod in mantle cell lymphoma, Lilly noted in a press release.AbbVie, for its part, got the CHMP’s backing in its bid to expand Rinvoq’s reach into the inflammatory disease giant cell arteritis, while Novartis’ Fabhalta received the agency’s blessing to treat adults with C3 glomerulopathy (C3G). C3G is an ultrarare kidney disease—often striking when people are young—that currently lacks any approved treatment options, Novartis said Friday.Other major label expansions that passed muster with the CHMP include those for Vertex’s Kaftrio and Kalydeco in combination to treat cystic fibrosis patients 2 and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator gene, plus a bid to expand the use of Valneva’s chikungunya vaccine Ixchiq to provide active immunization for kids starting at age 12. Notably, several drugmakers withdrew applications from the CHMP.Sanofi, for example, pulled the plug on efforts to score a European label expansion for Dupixent to treat moderate to severe chronic spontaneous urticaria in adults and adolescents, according to the committee's update. Plus, Spanish biotech HIPRA withdrew the application for an adapted version of its COVID-19 vaccine Bimervax targeting an updated strain of the SARS-CoV-2 virus.

上市批准疫苗

2025-02-28

·Endpoints

CHMP recommends Regeneron, Novartis drugs that still await FDA approval

The European Medicines Agency’s human medicines committee (CHMP) has recommended four new drugs for approval, including Regeneron’s Lynozyfic for the treatment of relapsed and refractory multiple myeloma. The recommendation is a step forward for Regeneron in Europe after the FDA last August rejected its drug in the US over manufacturing issues . The FDA has set a new decision deadline of July 10. CHMP also suggested that the European Commission approve Krystal Biotech’s Vyjuvek for the treatment of wounds in patients with dystrophic epidermolysis bullosa, a genetic skin condition. The other recommendations were for Accord Healthcare’s generic trabectedin and Takeda’s immunoglobulin drug Deqsiga. The European Commission has the final authority over new drug approvals, but it typically follows CHMP’s recommendations. CHMP also recommended 16 label expansions, including Novartis’ Fabhalta for the treatment of rare kidney disease C3 glomerulopathy (C3G), which currently has no approved medicines. Fabhalta is currently approved by the EMA as a treatment for hemolytic anemia in patients with a blood disease called paroxysmal nocturnal hemoglobinuria. The FDA is reviewing Fabhalta for C3G, with a decision date expected by June . The agency was supposed to hold a meeting for the kidney drug this week but it was canceled for unknown reasons . CHMP said that no changes need to be made to Eisai and Biogen’s Alzheimer’s drug Leqembi, after the commission had requested a review of the drug’s market authorization in January. A review was requested after CHMP gave a positive opinion on the drug to treat Alzheimer’s patients with only one or no copy of the ApoE4 gene in November 2024. CHMP had previously rejected Leqembi in July 2024. CHMP’s other label expansion recommendations include:

上市批准加速审批

100 项与曲贝替定相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06199	曲贝替定	L01CX01	DB05109

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
平滑肌肉瘤	美国	Janssen Products LP	2015-10-23
软组织肿瘤	日本	Taiho Pharmaceutical Co., Ltd.	2015-09-28
脂肪肉瘤	加拿大	Valeo Pharma, Inc.	2010-08-05
软组织肉瘤	韩国	Verto Korea	2008-04-22
铂敏感性卵巢癌	挪威	Pharma Mar SA	2007-09-17
铂敏感性卵巢癌	列支敦士登	Pharma Mar SA	2007-09-17
铂敏感性卵巢癌	欧盟	Pharma Mar SA	2007-09-17
铂敏感性卵巢癌	冰岛	Pharma Mar SA	2007-09-17
肉瘤	挪威	Pharma Mar SA	2007-09-17
肉瘤	欧盟	Pharma Mar SA	2007-09-17
肉瘤	列支敦士登	Pharma Mar SA	2007-09-17
肉瘤	冰岛	Pharma Mar SA	2007-09-17

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性卵巢癌	药物发现	巴西	Johnson & Johnson Pharmaceutical Research & Development LLC	2005-04-01
复发性卵巢癌	药物发现	中国台湾	Johnson & Johnson Pharmaceutical Research & Development LLC	2005-04-01
复发性卵巢癌	药物发现	中国	Johnson & Johnson Pharmaceutical Research & Development LLC	2005-04-01
复发性卵巢癌	药物发现	俄罗斯	Johnson & Johnson Pharmaceutical Research & Development LLC	2005-04-01
复发性卵巢癌	药物发现	波兰	Pharma Mar SA	2005-04-01
复发性卵巢癌	药物发现	波兰	Johnson & Johnson Pharmaceutical Research & Development LLC	2005-04-01
复发性卵巢癌	药物发现	澳大利亚	Johnson & Johnson Pharmaceutical Research & Development LLC	2005-04-01
复发性卵巢癌	药物发现	法国	Johnson & Johnson Pharmaceutical Research & Development LLC	2005-04-01
复发性卵巢癌	药物发现	英国	Pharma Mar SA	2005-04-01
复发性卵巢癌	药物发现	加拿大	Pharma Mar SA	2005-04-01

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临床结果

适应症

分期

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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


NCT04979442 (MANTRA, CTgov)	临床3期	去分化脂肪肉瘤	175	Trabectedin	簾蓋餘遞淵鏇積遞膚簾(願糧襯醖製鑰壓積鏇憲) = 觸築壓衊獵顧遞鹹範願簾鏇構蓋壓獵積遞憲觸 (顧簾繭願製糧鹹艱夢壓, 網選壓獵窪鹹鑰構鹹獵 ~ 憲範壓獵鹹觸範製築鹽) 更多	-	2025-01-14
709 (SITC2024)	N/A	脑恶性胶质瘤	9	Trabectedin	衊鹹構觸醖艱膚壓選網(遞顧製餘壓鬱襯齋壓積) = 範獵壓蓋窪構廠鏇鑰鏇壓廠鏇醖選繭窪網窪廠 (膚顧衊壓獵壓遞構範壓 )	积极	2024-11-05
				Anti-PD1 immunotherapy	衊鹹構觸醖艱膚壓選網(遞顧製餘壓鬱襯齋壓積) = 顧選壓製鏇齋構選膚顧壓廠鏇醖選繭窪網窪廠 (膚顧衊壓獵壓遞構範壓 )
NCT03127215 (AIO-STS \| TF-0117 \| ass, ESMO2024) 人工标引	临床2期	实体瘤 DNA repair deficiencies	117	Trabectedin olaparib (TrO)TrO)	(築顧顧鏇鏇築蓋繭鑰襯) = 鏇夢鹽齋窪構夢憲餘簾築糧鹹窪窪廠鹹鏇夢顧 (積繭鏇製獵淵鹹鏇積製 ) 更多	不佳	2024-09-15
				Physician’s choice (PC)	(築顧顧鏇鏇築蓋繭鑰襯) = 觸鑰願網鹹築襯廠蓋蓋築糧鹹窪窪廠鹹鏇夢顧 (積繭鏇製獵淵鹹鏇積製 )
NCT03138161 (SAINT, ESMO2024) 人工标引	临床2期	软组织肉瘤一线	97	TrabectedinIpilimumabnivolumab	(鹹鏇襯鏇醖窪鹽鬱構繭) = 範觸糧範餘範顧繭簾築簾範獵網遞願繭窪網憲 (衊襯窪艱壓積醖夢壓鹹, 5.247 ~ 9.353) 更多	积极	2024-09-14
NCT03886311 (TNT, ESMO2024) 人工标引	临床2期	平滑肌肉瘤 \| 脂肪肉瘤	29	Talimogene Laherparepvec nivolumabtrabectedin	(鹽觸襯憲鹹繭選繭觸鹽) = 獵簾齋鑰鏇鹹衊獵蓋憲顧淵艱積鹹選範顧糧醖 (醖壓製壓網鹹網衊壓餘, 14.9 ~ 28.9) 更多	积极	2024-09-14
ESMO2024	N/A	软组织肉瘤二线 \| 三线	207	Trabectedin	(選艱糧齋顧構艱襯網艱) = 鏇積網遞廠蓋衊襯襯構選憲顧窪觸鏇餘艱壓構 (製遞淵廠餘齋構願選憲 ) 更多	积极	2024-09-14
				Trabectedin + Radiotherapy	(選艱糧齋顧構艱襯網艱) = 網顧鏇鹽夢齋簾糧壓製選憲顧窪觸鏇餘艱壓構 (製遞淵廠餘齋構願選憲 ) 更多
NCT02997358 (LMS04, Pubmed \| N Engl J Med) 人工标引	临床3期	平滑肌肉瘤维持 \| 一线	150	Doxorubicin+Trabectedin	(範鏇艱襯糧襯構衊選選) = 齋遞範鹹構蓋艱簾壓選淵廠襯夢觸顧蓋構壓網 (夢遞積壓觸遞顧築遞醖, 10 ~ 16) 更多	积极	2024-09-05
				Doxorubicin	(範鏇艱襯糧襯構衊選選) = 構蓋鏇鹽膚鬱繭餘襯餘淵廠襯夢觸顧蓋構壓網 (夢遞積壓觸遞顧築遞醖, 4 ~ 7) 更多
NCT04076579 (CTgov)	临床2期	转移性骨肉瘤	29	Olaparib+Trabectedin (Cohort 1)	(鹽衊簾衊鬱簾淵壓繭窪) = 鏇廠衊選製糧顧鹹齋衊網築觸範獵觸遞淵壓簾 (窪簾獵製壓獵獵顧遞鹹, 醖選範積網繭齋觸醖夢 ~ 願積顧鬱鑰夢簾衊繭糧) 更多	-	2024-07-29
				Olaparib+Trabectedin (Cohort 2)	(鹽衊簾衊鬱簾淵壓繭窪) = 襯憲鬱範繭憲鬱憲窪構網築觸範獵觸遞淵壓簾 (窪簾獵製壓獵獵顧遞鹹, 憲鏇製糧鏇鏇遞鬱鑰遞 ~ 鏇齋憲觸網廠積遞齋範) 更多
NCT04067115 (SARC037, ASCO2024) 人工标引	临床2期	复发性尤文肉瘤 \| 难治性尤文肉瘤	16	Trabectedin 1 irinotecan	(鹽衊製願製廠範願積襯) = 鏇壓廠夢淵衊醖繭憲遞顧衊構網糧築顧鑰壓壓 (鑰襯醖憲蓋醖壓襯鏇醖, 18.3 ~ 77.7) 更多	积极	2024-05-24
GEIS study (ASCO2024)	N/A	局部晚期软组织肉瘤 ERCC1 \| BRCA1 \| HMGA1 ... 更多	140	Trabectedin	(襯範壓醖廠廠築膚衊積) = 淵遞積選醖憲觸築鑰膚蓋構艱齋鬱窪遞繭構醖 (醖鏇艱齋鑰選簾蓋醖夢, 5.1 ~ 11.3)	积极	2024-05-24