A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

开始日期2025-08-25

申办/合作机构

Janssen Research & Development LLC

CTR20242467

/ Recruiting临床3期

一项在携带易感型FGFR变异的中危非肌层浸润性膀胱癌（IR-NMIBC）受试者中评估TAR-210（Erdafitinib膀胱内给药系统）相比膀胱内单药化疗灌注的疗效和安全性的III期、随机化研究

本研究的主要目的是比较接受TAR-210的受试者与接受研究者选择的膀胱化疗灌注的受试者的DFS。

开始日期2024-07-25

申办/合作机构

强生（中国）投资有限公司

[+1]

CTIS2023-507684-19-00

/ Recruiting临床3期

Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations - 42756493BLC3004

开始日期2024-07-24

申办/合作机构-

100 项与厄达替尼相关的临床结果

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100 项与厄达替尼相关的转化医学

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100 项与厄达替尼相关的专利（医药）

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项与厄达替尼相关的文献（医药）

2025-05-01·EUROPEAN UROLOGY

European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2025 Guidelines

Review

作者: Smith, Emma J ; Bruins, Harman Max ; Sæbjørnsen, Sæbjørn ; Martini, Alberto ; Mariappan, Param ; Cathomas, Richard ; van der Heijden, Antoine G ; Dimitropoulos, Konstantinos ; Panebianco, Valeria ; Neuzillet, Yann ; Efstathiou, Jason A ; Thalmann, George N ; Fietkau, Rainer ; Lorch, Anja ; Mertens, Laura S ; Compérat, Eva ; Kailavasan, Mithun ; Meijer, Richard P ; Carrion, Albert ; Milowsky, Matthew I ; Rink, Michael

BACKGROUND AND OBJECTIVE:

This publication represents a summary of the updated 2025 European Association of Urology (EAU) guidelines for muscle-invasive and metastatic bladder cancer (MMIBC). The aim is to provide practical recommendations on the clinical management of MMIBC with a focus on diagnosis, treatment, and follow-up.

METHODS:

For the 2025 guidelines, new and relevant evidence was identified, collated, and appraised via a structured assessment of the literature. Databases searched included Medline, EMBASE, and the Cochrane Libraries. Recommendations within the guidelines were developed by the panel to prioritise clinically important care decisions. The strength of each recommendation was determined according to a balance between desirable and undesirable consequences of alternative management strategies, the quality of the evidence (including the certainty of estimates), and the nature and variability of patient values and preferences.

KEY FINDINGS AND LIMITATIONS:

The key recommendations emphasise the importance of thorough diagnosis, treatment, and follow-up for patients with MMIBC. The guidelines stress the importance of a multidisciplinary approach to the treatment of MMIBC patients and the importance of shared decision-making with patients. The key changes in the 2025 muscle-invasive bladder cancer (MIBC) guidelines include the following: a new recommendation for the use of susceptible FGFR3 alterations to select patients with unresectable or metastatic urothelial carcinoma for treatment with erdafitinib; significant adaption and update of the recommendations for pre- and postoperative radiotherapy and sexual organ-preserving techniques in women; new recommendation related to radical cystectomy and extent of lymph node dissection based on the results of the SWOG trial; recommendation related to hospital volume; new recommendations for salvage cystectomy after trimodality therapy and for the management of all patients who are candidates for trimodality bladder-preserving treatment in a multidisciplinary team setting using a shared decision-making process; significant adaption and update to the recommendation for adjuvant nivolumab in selected patients with pT3/4 and/or pN+ disease not eligible for, or who declined, adjuvant cisplatin-based chemotherapy; and addition of a new recommendation for metastatic disease regarding the antibody-drug conjugate trastuzumab deruxtecan in case of HER2 overexpression; in addition, removal of the recommendations on sacituzumab govitecan as the manufacturer has withdrawn the US Food and Drug Administration approval for this product; update of the follow-up of MIBC; and full update of the management algorithms of MIBC.

CONCLUSIONS AND CLINICAL IMPLICATIONS:

This overview of the 2025 EAU guidelines offers valuable insights into risk factors, diagnosis, classification, treatment, and follow-up of MIBC patients and is designed for effective integration into clinical practice.

2025-04-01·CANCER TREATMENT REVIEWS

Post-progression treatment options after CDK4/6 inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer

Review

作者: Sahin, Taha Koray ; Aksoy, Sercan ; Guven, Deniz Can ; Rizzo, Alessandro

The combination of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) and endocrine therapy (ET) is the standard first-line treatment for hormone receptor-positive (HR + ) and HER2-negative metastatic breast cancer (mBC). Despite their efficacy, resistance inevitably develops, necessitating alternative therapeutic strategies post-progression. This review explores current and emerging treatment options following progression on CDK4/6i, focusing on endocrine therapies, targeted therapies, combination approaches, and the continued use of CDK4/6i. Endocrine therapies, including fulvestrant and novel oral selective estrogen receptor degraders (SERDs) like elacestrant, show promise, especially in patients with ESR1 mutations. Targeted therapies such as PI3K/AKT/mTOR inhibitors, exemplified by alpelisib and capivasertib, offer potential by addressing downstream signaling pathways involved in resistance. Additionally, FGFR inhibitors like erdafitinib are under investigation for their role in overcoming specific resistance mechanisms. Combination strategies involving CDK4/6 inhibitors with immune checkpoint inhibitors or other targeted agents are also being explored, with early trials suggesting possible synergistic effects, although further validation is required. Continuation of CDK4/6 inhibitors beyond progression has shown potential benefits in selected patients, but the data are heterogeneous, and further studies are needed to clarify their role. While chemotherapy remains a standard option for patients who progress on these treatments, the goal is to delay its use through the effective utilization of endocrine and targeted therapies. Understanding resistance mechanisms and tailoring treatment to individual patient profiles is crucial for optimizing outcomes. Ongoing clinical trials are expected to provide deeper insights, guiding the development of more effective post-progression therapeutic strategies. This evolving landscape highlights the need for continuous research and individualized patient care to improve survival and quality of life in HR + mBC patients.

2025-04-01·ANNALS OF ONCOLOGY

The unjustified fear of erdafitinib induced central serous retinopathy

Letter

作者: Peeters, Freya ; Strijbos, Michiel ; Vulsteke, Christof ; Schauwvlieghe, Pieter-Paul

151

项与厄达替尼相关的新闻（医药）

2025-04-28

·求实药社

强生公布重磅药械组合用于膀胱癌数据，45%完全缓解率，维持1年以上

来源：新猎药人笔记近日，强生公司（Johnson&Johnson）公布了其膀胱癌药物TAR-200的持久性数据。TAR-200是一种药物器械组合，用于治疗某些膀胱癌患者。此次公布的数据显示，该药物在治疗膀胱癌方面具有较高的完全缓解率和持久性。TAR-200是一种创新的膀胱内药物释放系统，能够持续将化疗药物吉西他滨（gemcitabine）直接释放到膀胱内。这种药物器械组合的设计旨在为那些对卡介苗（BCG）无反应的高危非肌层浸润性膀胱癌（NMIBC）患者提供一种新的治疗选择。在拉斯维加斯举行的美国泌尿协会年会上，周六公布的研究结果显示，接受 TAR-200 治疗的患者中，近 45% 达到了完全缓解（CR）状态，并且至少维持了 12 个月。这些数据表明，TAR-200在治疗高危NMIBC方面具有显著的疗效和持久性。今年1月份公布TAR-200的IIb期SunRISe-1研究。该研究显示，接受TAR-200单药治疗的患者中，完全缓解率（CR）达到了83.5%，且在中位随访9个月时，82%的患者维持了完全缓解。强生公司已于2025年1月向美国食品药品监督管理局（FDA）提交了TAR-200的滚动申请。该申请得到了FDA的实时肿瘤学审查（RTOR）计划的支持，该计划旨在加速某些肿瘤药物或生物制品的审批过程。TAR-200获得了FDA授予的突破性疗法认定，这将进一步加快其开发和审查进程。结束语：膀胱癌是全球十大常见癌症之一，而NMIBC患者在初始BCG治疗无效后，治疗选择有限。TAR-200及其后续产品TAR-210有望在膀胱癌治疗领域占据重要地位，强生公司预计这两种药物的峰值销售额可能达到50亿美元。如果获得批准，TAR-200将成为首个用于该适应症的膀胱内药物释放系统。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。联系我们IND 2025展位火热销售中！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！

突破性疗法临床2期临床申请快速通道临床结果

2025-04-27

·亚虹医药

亚虹医药及其子公司Baylink关于AI小分子和ADC平台研究成果亮相2025年美国癌症研究协会年会

中国上海，2025年4月27日 –聚焦泌尿生殖系统肿瘤及女性健康的全球化创新药公司亚虹医药（www.asieris.cn,股票代码：688176.SH）及其子公司Baylink Biosciences Inc. (www.baylinkbio.com), 近日宣布在当地时间4月25日至30日美国芝加哥举行的2025年美国癌症研究协会（AACR）年会上,以壁报形式公布了三项临床前研究成果如下：摘要标题：ASN-7350, a highly selective FGFR2/3 dual inhibitor, for FGFR2/FGFR3 driven solid tumorsASN-7350，一种高选择性FGFR2/3双靶点抑制剂，用于治疗FGFR2/FGFR3驱动型实体瘤摘要编号：3014会议日期和时间：当地时间 2025年4月28日14:00 - 17:00 研究背景：当前，第一代泛FGFR抑制剂在特定实体瘤治疗中已实现临床应用突破：厄达替尼（Erdafitinib）获批用于FGFR突变的晚期或转移性尿路上皮癌，佩米替尼（Pemigatinib）和福巴替尼（Futibatinib）获准用于FGFR2异常的肝内胆管癌治疗。然而，这类药物也面临双重挑战：其一，由于对FGFR1和FGFR4亚型的非选择性抑制导致脱靶毒性，导致包括高磷血症等剂量限制性不良反应；其二，治疗过程中频发的FGFR2/3激酶域获得性耐药突变（如FGFR2 N549K和FGFR3 V555M），显著削弱了其长期疗效。针对这一未满足的临床需求，公司研发团队基于结构药理学策略，成功开发出具有差异化优势的FGFR2/3双靶点小分子抑制剂ASN-7350。结论：针对现有泛FGFR抑制剂存在的FGFR1/4相关毒性和获得性耐药问题，ASN-7350通过非共价结合机制实现选择性抑制，在临床前研究中展现出优于同类候选药物（RLY-4008、TYRA-300）的广谱抗肿瘤活性。该化合物可有效克服FGFR2/3耐药突变，治疗窗显著拓宽，适用于包括膀胱癌、子宫内膜癌和胃癌在内的多种FGFR2/3驱动型实体瘤。目前该项目已经正式进入IND Enabling阶段，期望在2025年年底前获得临床批件。摘要标题：A linker platform for antibody drug conjugates (ADCs): expanding the therapeutic window抗体药物偶联物（ADC）连接子平台：拓宽治疗窗口摘要编号：7463会议日期和时间：当地时间 2025年4月30日 9:00 - 12:00研究背景：尽管抗体偶联药物（ADC）已展现出极大的临床潜力，但由于这种药物形式的复杂性，其治疗窗口仍然很小，限制了相关药物的临床开发。其中有效载荷（payload）的疏水性和ADC分子的不稳定性是关键的因素。好的连接子（linker）能够改善ADC分子疏水性并提高其稳定性，减少副作用并拓宽治疗窗口。结论：公司开发了一组新型连接子，其特性在于通过提高ADC的亲水性和稳定性、减少脱靶效应，同时保持疗效，从而扩展当前ADC的治疗窗口。这些连接子的优势已在多个项目中得到证实，其中领先项目（CLDN6/9 ADC）预计将在2026年中期递交IND。此外，公司还在拓展这类连接子的应用，以促进双有效载荷ADC和降解剂-抗体偶联物（Degrader–Antibody–Conjugates）的创新设计。摘要标题：Preclinical evaluation of BLB-101, a topoisomerase-inhibitor-based anti-CLDN6/9 antibody-drug conjugate featuring a proprietary hydrophilic linkerBLB-101的临床前评估：搭载专有亲水性连接子、基于拓扑异构酶抑制剂的抗CLDN6/9抗体药物偶联物（ADC）摘要编号：1578会议日期和时间：当地时间 2025年4月28日 9:00 - 12:00研究背景：Claudin 6 (CLDN6) 是一种紧密连接蛋白，在多种人类癌症中高度表达，包括卵巢癌、子宫内膜癌和非小细胞肺癌（NSCLC），但在正常成人组织中不存在。与 CLDN6 具有高度同源性的 Claudin 9 (CLDN9) 也表现出类似的表达模式，在正常组织中几乎不存在，但在卵巢癌和子宫内膜癌中被上调表达。公司提出利用ADC的药物形式同时靶向 CLDN6 和 CLDN9，可以增强抗肿瘤疗效，并为更多患者提供治疗选择。结论：公司成功筛选出一个高亲和力抗体，可特异性结合 CLDN6 和 CLDN9，同时避免与其他 Claudin 家族成员结合。BLB-101结合了该CLDN6/9抗体并用拓扑异构酶 I 抑制剂作为有效载荷，采用了我们自主研发的亲水性连接子 BL001。BLB-101展现出强大的生物活性、良好的体内药代动力学（PK）特性以及优异的可开发性。BLB-101 在多种抗原阳性癌细胞系中表现出强大的细胞杀伤作用。在 CLDN6 或 CLDN9 表达的异种移植模型中，BLB-101 低剂量即可实现肿瘤消除。此外，在非人灵长类动物中，BLB-101表现出良好的耐受性。综上所述，这些研究结果强有力地支持 BLB-101在临床上进一步开发。如以上两款重要在研产品和一个技术平台的成果所示，亚虹医药和其专注ADC的子公司Baylink Biosciences Inc.展现了突出的新药研发实力，这些药物有望为肿瘤患者带来更多的福音。关于亚虹医药亚虹医药（股票代码：688176.SH）成立于2010年3月，是一家专注于泌尿生殖系统肿瘤及女性健康领域的全球化创新药公司。秉承“改善人类健康，让生命更有尊严”的企业使命，亚虹医药立志成为在专注治疗领域集研发、生产和商业化为一体的国际领先制药企业，为中国和全球患者提供最佳的诊疗一体化解决方案。公司坚持以创新技术和产品为核心驱动力，通过打造自有的研发平台和核心技术，深入探索药物作用机理，高效率筛选评价候选药物。通过内部完善的研发体系和全球药物开发经验专长，亚虹医药致力于在专注治疗领域推出全球首创（First-in-Class）药物和其它存在巨大未被满足治疗需求的创新药物。同时，亚虹医药通过自主研发和战略合作，围绕泌尿生殖系统疾病进行产品管线的深度布局，高度关注该领域的技术前沿和治疗发展趋势，洞察并挖掘未被满足的临床需求，前瞻性地进行产品规划和生命周期管理，打造涵盖疾病诊断到治疗的优势产品组合，从而造福更多的中国和全球患者。欲了解更多信息，请访问www.asieris.cn。

抗体药物偶联物AACR会议临床申请临床结果临床1期

2025-04-21

·PRNewswire

Johnson & Johnson unveils highly anticipated and potential practice-changing data in bladder cancer treatment at AUA

TAR-200 monotherapy shows highest complete response with sustained benefits in 12-month data from Phase 2b SunRISe-1 study (Cohort 2) Compelling first results from Cohort 4 of Phase 2b SunRISe-1 study show potential of TAR-200 monotherapy in patients with papillary-only, high-risk non-muscle invasive bladder cancer RARITAN, N.J., April 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that new data from its leading oncology pipeline will be presented at the American Urological Association (AUA) 2025 Annual Meeting, taking place April 26-29 in Las Vegas. Among the highlights are the 12-month duration of response (DOR) data from the Phase 2b Cohort 2 SunRISe-1 study, evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with Bacillus Calmette-Guérin (BCG)—unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS) with or without papillary disease. These findings will be featured in the Practice-changing, Paradigm-shifting Clinical Trials in Urology plenary session on Saturday, April 26. Bladder cancer ranks among the top ten most common cancers worldwide, affecting nearly a million people each year.1 Despite advancements, standard treatment has remained largely unchanged for over 40 years, leaving patients with limited treatment options if initial BCG therapy does not work.2 TAR-200 delivers sustained medication directly into the bladder and, in a pre-clinical setting, has been shown to allow for depth of penetration across bladder tissue layers.3 "Patients with bladder cancer need more effective treatment options that are both tolerable and easily incorporated into everyday practice, especially for those with HR-NMIBC, a highly recurrent disease that often necessitates difficult, life-altering decisions like bladder removal," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "TAR-200 provides a new approach, with clinical data showing an impressive complete response rate, meaning the cancer was undetectable following treatment. The highly anticipated 12-month duration of response findings from our Cohort 2, SunRISe-1 study further support the potential for patients to remain cancer-free for a clinically meaningful period." A second plenary presentation will feature first results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating TAR-200 monotherapy in patients with BCG–unresponsive, papillary-only HR-NMIBC. In this patient population, bladder removal remains a standard treatment, but many patients are elderly, have significant comorbidities, or are unwilling to undergo radical surgery, making treatment challenging.4 "Patients deserve more than the currently available treatment options. TAR-200 is a groundbreaking therapy for early-stage bladder cancer, designed to deliver a sustained local release of medication directly into the bladder—right where it is needed," said Biljana Naumovic, U.S. President, Oncology, Solid Tumor, Johnson & Johnson Innovative Medicine. "This innovation provides a bladder-sparing treatment option that can meaningfully improve outcomes while integrating seamlessly into any urology practice." TAR-200 is inserted directly into the bladder by a healthcare professional in a brief outpatient, in-office procedure, without the need for anesthesia. Designed to remain in the bladder, it does not interfere with daily activities and provides sustained release of medication throughout the day. To date, TAR-200 has been placed more than 10,000 times as part of the SunRISe clinical program. AUA 2025 Presentation Highlights: One-year duration of response data from the Phase 2b SunRISe-1 study evaluating TAR-200 monotherapy in patients with BCG–unresponsive, HR-NMIBC plus carcinoma in situ with or without papillary disease (P2 Plenary Presentation). First results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating TAR-200 monotherapy in patients with BCG–unresponsive papillary-only HR-NMIBC (P2 Plenary Presentation). Trial-in-progress mini-oral presentation from the Phase 3 MoonRISe-1 study evaluating TAR-210, an erdafitinib intravesical drug-releasing system, versus intravesical chemotherapy in patients with fibroblast growth factor receptors (FGFR)-altered intermediate-risk NMIBC (Clinical Trials in Progress Presentation). Trial-in-progress presentation from the Phase 3 SunRISe-5 study evaluating TAR-200 compared to intravesical chemotherapy after treatment with BCG in patients with recurrent HR-NMIBC (Clinical Trials in Progress Presentation). Real-world time-to-next-treatment and time-to-castration-resistance among patients with metastatic castration-sensitive prostate cancer using androgen-receptor pathway inhibitors with and without homologous recombination repair alterations (Oral Presentation #25-3830). A complete list of Johnson & Johnson's sponsored abstracts is available on JNJ.com. About TAR-200 TAR-200 is an investigational intravesical gemcitabine releasing system. In January 2025, Johnson & Johnson announced the initiation of a new drug application with the FDA for TAR-200 under the real-time oncology review (RTOR) program. In December 2023, the FDA granted Breakthrough Therapy Designation (BTD) to TAR-200 for the treatment of adult patients with BCG—unresponsive HR-NMIBC with CIS who are ineligible for or have elected not to undergo radical cystectomy. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with MIBC in SunRISe-4, and NMIBC in SunRISe-1, SunRISe-3 and SunRISe-5. About TAR-210 TAR-210 is an investigational intravesical erdafitinib releasing system. The safety and efficacy of TAR-210 is being evaluated in a Phase 1 study (NCT05316155) in patients with muscle-invasive bladder cancer (MIBC) and NMIBC. About High-Risk Non-Muscle-Invasive Bladder Cancer High-risk non-muscle-invasive bladder cancer is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to invasive bladder cancer compared to low-risk NMIBC.5,6 HR-NMIBC makes up 15-44 percent of patients with NMIBC and is characterized by a high-grade, large tumor size, presence of multiple tumors, with or without CIS.7 Radical cystectomy is currently recommended for NMIBC patients who fail BCG therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression.8,9 Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.10 The high rates of recurrence and progression can pose significant morbidity and distress for these patients.3,6 About Prostate Cancer Approximately 300,000 people are diagnosed with prostate cancer each year in the U.S.11 Up to 40 percent of patients will be classified as high-risk.12 Despite advancements in treatment, disease recurrence remains substantial; up to 50 percent of patients within ten years of surgery experience recurrence and carry a significant risk of disease progression and death.13 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen Scientific Affairs, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TAR-200, TAR-210 or BALVERSA® (erdafitinib). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen Scientific Affairs, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen Scientific Affairs, LLC nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments. 1 2 Dobruch J, Oszczudłowski M. Bladder Cancer: Current Challenges and Future Directions. Medicina (Kaunas). 2021;57(8):749. Published 2021 Jul 24. doi:10.3390/medicina57080749 3 Pradère B., et al. PENELOPE: Tissue penetration of gemcitabine phosphate metabolites following TAR-200 administration versus standard intravesical instillation in minipigs. EAU 2025. March 23, 2025. 4 Lebacle C, Loriot Y, Irani J. BCG-unresponsive high-grade non-muscle invasive bladder cancer: what does the practicing urologist need to know?. World J Urol. 2021;39(11):4037-4046. doi:10.1007/s00345-021-03666-w 5 Grab-Heyne K, Henne C, Mariappan P, et al. Intermediate and high-risk non–muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023;13:1170124. 6 Lieblich A, Henne C, Mariappan P, Geiges G, Pöhlmann J, Pollock RF. The management of non–muscle-invasive bladder cancer: a comparison of European and UK guidelines. J Clin Urol. 2018;11(2):144-148. 7 Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022;81(1):75-94. doi:10.1016/j.eururo.2021.08.010 8 Brooks NA, O'Donnell MA. Treatment options in non–muscle-invasive bladder cancer after BCG failure. Indian J Urol. 2015;31(4):312-319. doi:10.4103/0970-1591.166475 9 Guancial EA, Roussel B, Bergsma DP, et al. Bladder cancer in the elderly patient: challenges and solutions. Clin Interv Aging. 2015;10:939-949. 10 Chamie K, Litwin MS, Bassett JC, et al. Recurrence of high-risk bladder cancer: A population-based analysis. Cancer. 2013;119(17):3219-3227. 11 Key statistics for prostate cancer. American Cancer Society. Accessed September 2024. 12 Cooperberg MR, Cowan J, Broering JM, et al. High-risk prostate cancer in the United States, 1990-2007. World J Urol. 2008;26(3):211-218. doi: 10.1007/s00345-008-0250-7. 13 Napodano G, Ferro M, Sanseverino R. High-risk prostate cancer: A very challenging disease in the field of uro-oncology. Diagnostics (Basel). 2021;11(3):400. doi: 10.3390/diagnostics11030400. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床3期突破性疗法

100 项与厄达替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10927	厄达替尼	L01XE	DB12147

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
局部晚期尿路上皮癌	中国	上海强生制药有限公司	2025-01-08
转移性尿路上皮癌	欧盟	Janssen-Cilag International NV	2024-08-22
转移性尿路上皮癌	冰岛	Janssen-Cilag International NV	2024-08-22
转移性尿路上皮癌	列支敦士登	Janssen-Cilag International NV	2024-08-22
转移性尿路上皮癌	挪威	Janssen-Cilag International NV	2024-08-22
不可切除的尿路上皮癌	欧盟	Janssen-Cilag International NV	2024-08-22
不可切除的尿路上皮癌	冰岛	Janssen-Cilag International NV	2024-08-22
不可切除的尿路上皮癌	列支敦士登	Janssen-Cilag International NV	2024-08-22
不可切除的尿路上皮癌	挪威	Janssen-Cilag International NV	2024-08-22
FGFR2阳性尿路上皮癌	韩国	Janssen Korea Ltd.	2022-11-24
FGFR3阳性尿路上皮癌	韩国	Janssen Korea Ltd.	2022-11-24
膀胱癌	加拿大	Janssen Biotech, Inc.	2019-12-09
尿路上皮癌	加拿大	Janssen, Inc.	2019-10-25
FGFR阳性尿路上皮癌	美国	Janssen Biotech, Inc.	2019-04-12

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
晚期尿路上皮癌	申请上市	中国	Janssen Biotech, Inc.	2023-12-15
晚期尿路上皮癌	申请上市	中国	上海强生制药有限公司	2023-12-15
晚期尿路上皮癌	申请上市	中国	Janssen Cilag SpA	2023-12-15
非肌层浸润性膀胱肿瘤	临床3期	美国	Janssen Research & Development LLC	2024-04-01
非肌层浸润性膀胱肿瘤	临床3期	中国	Janssen Research & Development LLC	2024-04-01
非肌层浸润性膀胱肿瘤	临床3期	日本	Janssen Research & Development LLC	2024-04-01
非肌层浸润性膀胱肿瘤	临床3期	阿根廷	Janssen Research & Development LLC	2024-04-01
非肌层浸润性膀胱肿瘤	临床3期	奥地利	Janssen Research & Development LLC	2024-04-01
非肌层浸润性膀胱肿瘤	临床3期	比利时	Janssen Research & Development LLC	2024-04-01
非肌层浸润性膀胱肿瘤	临床3期	巴西	Janssen Research & Development LLC	2024-04-01

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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


AACR2025	N/A	FGFR2突变肿瘤 FGFR2/3 alterations	60	erdafitinib (Predicine FGFR2/3 qPCR Kit)	糧選衊蓋鑰觸積廠簾繭(鹽鏇壓壓襯壓構鏇衊衊) = 鑰鏇衊鹽衊構齋選鹹鬱範觸鏇範醖淵艱觸製網 (壓築衊簾鹹蓋鑰鬱淵願 ) 更多	积极	2025-04-27
NCT04083976 (RAGNAR, CTgov)	临床2期	晚期恶性实体瘤	316	erdafitinib (Broad Panel Cohort)	膚餘憲鑰淵壓構鏇窪艱 = 鬱膚糧廠窪遞網鬱鏇簾構鑰襯衊夢蓋衊憲鹽繭 (夢廠願膚淵蓋醖簾餘製, 網糧遞繭顧顧範構獵獵 ~ 選鏇餘襯壓製鑰壓構繭) 更多	-	2025-02-24
NCT04083976 (RAGNAR, CTgov)	临床2期	晚期恶性实体瘤	316	erdafitinib (Pediatric Cohort)	膚餘憲鑰淵壓構鏇窪艱 = 鬱窪遞積壓鬱襯餘鹽鬱構鑰襯衊夢蓋衊憲鹽繭 (夢廠願膚淵蓋醖簾餘製, 蓋廠獵夢憲艱蓋淵範餘 ~ 壓糧襯繭構獵壓糧襯夢) 更多	-	2025-02-24
NCT04963153 (ETCTN 10483, ASCO_GU2025) 人工标引	临床1期	转移性尿路上皮癌 FGFR3 Mutation \| FGFR2 Mutation	9	Erdafitinib + Enfortumab Vedotin	積顧艱襯顧構襯積憲選(蓋繭顧觸艱願範鬱願構) = hyperphosphatemia (88%), mucositis (88%), high AST (88%), hypercalcemia (75%), palmar plantar erythrodysesthesia (75%), peripheral neuropathy (75%), alopecia (63%), diarrhea (63%), hypoalbuminemia (63%) and hypomagnesemia (63%). 窪網繭衊膚鹽憲構淵鹽 (鑰廠餘衊齋糧餘糧醖顧 ) 更多	积极	2025-02-13
NCT03210714 (APEC1621B, CTgov)	临床2期	难治性软组织肉瘤 \| 难治性中枢神经系统淋巴瘤 \| 复发性髓母细胞瘤 ... 更多	20	Computed Tomography+Erdafitinib	製憲餘蓋鑰糧醖積鏇醖 = 壓顧築鏇積鏇衊夢繭遞積構齋餘鬱壓獵築觸網 (繭壓憲艱鏇膚鬱齋鹽鏇, 觸獵廠繭齋廠蓋廠憲窪 ~ 糧衊憲築鏇觸衊積網選) 更多	-	2024-09-19
NCT05316155 (ESMO2024)	临床1/2期	FGFR阳性胆管癌	-	TAR-210	夢製艱繭膚蓋鬱觸襯製(顧憲觸製衊齋顧積壓積) = 淵遞獵夢衊製餘製壓構齋糧選夢夢鑰獵簾餘願 (衊網蓋壓顧獵鑰範鹹壓 ) 更多	-	2024-09-15
NCT02699606 (Pubmed \| BMC Cancer) 人工标引	临床2期	晚期恶性实体瘤 FGFR genomic aberrations	35	Erdafitinib 8 mg once daily	鹹顧鏇網築觸製廠積餘(糧鹹簾糧糧淵鹹鏇網餘) = 鏇選蓋獵淵鹽繭網衊築顧窪鹽窪鬱願廠構鑰膚 (願繭獵壓壓餘蓋淵夢範, 20.7 ~ 63.6) 更多	积极	2024-08-13
NCT02699606 (Pubmed \| BMC Cancer) 人工标引	临床2期	晚期恶性实体瘤 FGFR genomic aberrations	35	Erdafitinib 10 mg (7 days on/7 days off)	鹹顧鏇網築觸製廠積餘(糧鹹簾糧糧淵鹹鏇網餘) = 鹽選餘憲遞糧艱繭壓憲顧窪鹽窪鬱願廠構鑰膚 (願繭獵壓壓餘蓋淵夢範 ) 更多	积极	2024-08-13
NCT04083976 (RAGNAR, ASCO2024) 人工标引	临床2期	乳腺癌 FGFR Mutation (Activating)	16	Erdafitinib 8 mg daily	鹽獵製範醖糧顧觸艱窪(醖顧淵夢壓構獵鬱壓餘) = 鹹網窪糧膚獵繭夢簾鬱衊構衊鏇願顧願鑰蓋選 (醖艱範衊製齋鹹憲鏇艱, 11 ~ 59) 更多	积极	2024-05-24
NCT04083976 (RAGNAR, ASCO2024) 人工标引	临床2期	晚期恶性实体瘤 FGFR1 \| FGFR2 \| FGFR3 ... 更多	53	Erdafitinib 8 mg daily	製顧糧壓膚憲網鹹膚鹹(製鏇餘憲淵鏇窪構夢鹹) = 範範廠繭構壓網憲醖選衊糧顧簾蓋壓壓選膚蓋 (願繭鏇積選願艱齋廠糧 ) 更多	不佳	2024-05-24
NCT04083976 (RAGNAR, ASCO2024) 人工标引	临床2期	非小细胞肺癌 CDKN2A \| FGFR mutations \| FGFR fusions ... 更多	23	Erdafitinib	製淵壓廠選鬱顧齋願製(艱憲壓簾遞製鏇壓積鏇) = 醖餘蓋鹹夢糧網鹹網願廠簾網構願簾廠選衊蓋 (憲鹹糧憲襯願窪餘齋願, 10 ~ 48) 更多	积极	2024-05-24
NCT02699606 \| NCT04083976 (RAGNAR and LUC2001, ASCO2024)	临床2期	食管癌 \| 晚期恶性实体瘤 \| 晚期非小细胞肺癌 ... 更多	78	Erdafitinib 8 mg daily	襯鏇繭窪壓夢餘鹽繭膚(觸網顧壓襯選廠壓蓋鹹) = 68% 繭憲簾築簾壓繭鹽鏇憲 (窪獵製簾淵艱鏇鹽壓糧 ) 更多	积极	2024-05-24