曲妥珠单抗(Trastuzumab) - 药物靶点：HER2_在研适应症：HER2阳性结直肠癌，HER2阳性唾液腺癌，HER2阳性胃癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-HER2/neu-MAb、Trastuzumab (Genetical Recombination)、Trastuzumab (genetical recombination) (JAN)

+ [15]

靶点

HER2

作用机制

HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)、ADCC(抗体依赖的细胞毒作用)

治疗领域

肿瘤消化系统疾病口颌疾病+ [8]

在研适应症

HER2阳性结直肠癌HER2阳性唾液腺癌HER2阳性胃癌+ [45]

非在研适应症

进展期胃腺癌晚期 HER2 阳性乳腺癌晚期尿路上皮癌+ [15]

原研机构

Genentech, Inc.

在研机构

Genentech, Inc.

Seagen Inc.Roche Pharma (Schweiz) AG

+ [12]

非在研机构

Pfizer Inc.

Sanofi

Bristol Myers Squibb Co.

最高研发阶段批准上市

首次获批日期

美国 (1998-09-25),

转移性乳腺癌

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (日本)

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序列信息

Sequence Code 18481L

来源: *****

Sequence Code 44772H

来源: *****

关联

972

项与曲妥珠单抗相关的临床试验

NCT06439693 / Not yet recruiting临床2期IIT

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study:

The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.
The names of the study drugs involved in this study are:
Paclitaxel (a type of anti-microtubule agent)
Docetaxel (a type of anti-microtubule agent)
Nab-Paclitaxel (a type of anti-microtubule agent)
Trastuzumab (a type of IgG1 kappa monoclonal antibody)
Pertuzumab (a type of monoclonal antibody)
Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate)
Tucatinib (Tyrosine Kinase HER2 Inhibitor)
Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)

开始日期2024-11-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06038539 / Not yet recruiting临床3期

A Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of the Proposed Biosimilar PERT-IJS and EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Patients With Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Stage or Locally Advanced Breast Cancer

To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in neoadjuvant treatment of patients with HR-ve and HER-2 positive early stage or locally advanced breast cancer.

开始日期2024-09-15

申办/合作机构

Biocon Ltd.

NCT06490536 / Not yet recruiting临床3期IIT

A Precision Medicine Trial Leveraging Blood-Based Tumor Genomics to Optimize Treatment in Operable Stage III and High-Risk Stage II Colon Cancer Patients

Background & Rationale:
Colon cancer is a leading cause of cancer deaths, with a high recurrence rate in stage II high-risk and stage III patients due to undetectable micro-metastases. Liquid biopsy (LB) detects residual cancer DNA post-surgery and monitors treatment response.
Primary Objective:
Show that therapy based on tumor genetics and LB improves outcomes and quality of life for high-risk stage II and stage III colon cancer patients compared to conventional therapy.
Secondary Objectives:
Compare recurrence times. Evaluate side effects and quality of life. Assess cost differences. Validate LB accuracy.
Study Design: Patients are randomized into standard or personalized treatment groups based on LB results.
For positive LB results:
Randomized to standard or customized therapy. Monitor treatment response with LB.
For negative LB results:
Randomized to standard chemotherapy or follow-ups, starting treatment if a positive result appears.
Treatments:
Standard Chemotherapy:
CAPOX (capecitabine and oxaliplatin) FOLFOX (folinic acid, fluorouracil, and oxaliplatin)
Personalized Treatments:
Customized chemotherapy with CAPOX. Immunotherapy with nivolumab and ipilimumab. Targeted therapy with trastuzumab and pertuzumab. FOLFOX with anti-EGFR (epidermal growth factor receptor) therapy (panitumumab).
Population: 700 patients with operable stage III and high-risk stage II colon cancer.
Inclusion Criteria:
Aged 18 or older. Confirmed diagnosis. Tumor tissue sample available.
Exclusion Criteria:
History of other tumors within five years. Incomplete colonoscopy or recent polyp removal. Metastatic disease or recent experimental study participation. Major cardiovascular diseases, intestinal obstruction, autoimmune diseases, neuropathy, HIV (Human Immunodeficiency Virus), active TB (Tuberculosis), or hepatitis B/C infection.
Medical conditions contraindicating treatment.
Endpoints:
Primary:
Evaluate disease recurrence after two years.
Secondary:
Assess disease recurrence and overall survival at 3 and 5 years. Measure treatment safety and tolerability. Validate LB accuracy. Monitor quality of life using questionnaires.
The study will last 5 years and be conducted in 25-30 hospitals across Italy, Spain, and Germany.

开始日期2024-09-01

申办/合作机构-

100 项与曲妥珠单抗相关的临床结果

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100 项与曲妥珠单抗相关的转化医学

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100 项与曲妥珠单抗相关的专利（医药）

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12,621

项与曲妥珠单抗相关的文献（医药）

2024-01-01·Journal of cancer research and clinical oncology

Efficacy and safety of first-line therapy in patients with HER2-positive advanced breast cancer: a network meta-analysis of randomized controlled trials

Review

作者: Yu, Yushuai ; Zhang, Jie ; Wang, Junxiao ; Song, Chuangui ; Lin, Qisheng

Abstract:

Purpose:

The numerous first-line treatment regimens for human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer (ABC) necessitate a comprehensive evaluation to inform clinical decision-making. We conducted a Bayesian network meta-analysis (NMA) to compare the efficacy and safety of different interventions.

Methods:

We systematically searched for relevant randomized controlled trials (RCTs) in Pubmed, Embase, Cochrane Library and online abstracts from inception to June 1, 2023. NMA was performed to calculate and analyze progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and adverse events of grade 3 or higher (≥ 3 AEs).

Results:

Out of the 10,313 manuscripts retrieved, we included 28 RCTs involving 11,680 patients. Regarding PFS and ORR, the combination of trastuzumab with tyrosine kinase inhibitors (TKIs) was more favorable than dual-targeted therapy. If only using trastuzumab, combination chemotherapy is superior to monochemotherapy in terms of PFS. It is important to note that the addition of anthracycline did not result in improved PFS. For patients with hormone receptor-positive HER2-positive diseases, dual-targeted combined with endocrine therapy showed better benefit in terms of PFS compared to dual-targeted alone, but it did not reach statistical significance. The comprehensive analysis of PFS and ≥ 3 AEs indicates that monochemotherapy combined with dual-targeted therapy still has the optimal balance between efficacy and safety.

Conclusion:

Monochemotherapy (Docetaxel) plus dual-target (Trastuzumab and Pertuzumab) therapy remains the optimal choice among all first-line treatment options for ABC. The combination of trastuzumab with TKIs (Pyrotinib) demonstrated a significant improvement in PFS and ORR, but further data are warranted to confirm the survival benefit.

2024-05-01·Current cancer drug targets

The Efficacy and Safety of Inetetamab and Pyrotinib in Combination with Vinorelbine for Second-line Therapy and Beyond in HER2-positive Metastatic Breast Cancer: A Single-institution Clinical Experience

Article

作者: Wu, Xiufeng ; Huang, Weiwei ; Li, Chongyin ; Chen, Xinhua ; Li, Nani ; Wu, Fan ; Chen, Mulan ; Chen, Kan ; Wang, Lili ; Liu, Jian ; Lin, Lin ; Hong, Yi

Background and Objective::

This study aimed to observe the efficacy and safety of inetetamab and pyrotinib in combination with vinorelbine in second-line therapy and beyond in HER2-positive metastatic breast cancer (MBC).

Methods::

Patients with HER2-positive MBC admitted to our hospital from January 2016 to December 2021 were selected. For patients who could not receive antibody‒drug conjugates (ADCs) during second-line (2nd-line) or third-line and beyond (≥ 3rd-line) anti-HER2 therapy, inetetamab + pyrotinib + vinorelbine was used for treatment until unacceptable adverse events occurred or the disease progressed, as evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 every 2 cycles. The progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR), and adverse reactions were recorded. Multivariate Cox regression analysis was performed to explore the prognostic factors influencing the curative effect.

Results::

Overall, 52 patients were included; 13 patients received 2nd-line treatment, and 39 patients received ≥ 3rd-line treatment. The median PFS (mPFS) for all patients treated with inetetamab + pyrotinib + vinorelbine was 7 months. The mPFS of the 2nd-line subgroup was significantly better than that of the ≥ 3rd-line subgroup (17 vs. 5 months, P = 0.001). The mPFS of the subgroups that received trastuzumab (H) or trastuzumab and pertuzumab (HP) only was significantly better than that of the H or HP and tyrosine kinase inhibitor (TKI) subgroups (8 vs. 5 months, P = 0.030). The mPFS of the HER2 resistance subgroup was better than that of the HER2 refractoriness subgroup (14 vs. 7 months, P = 0.025). Cox regression analysis showed that the treatment line (2nd-line more so than ≥ 3rd-line) was an independent prognostic factor for PFS. In addition, the ORR and CBR of 2nd-line patients were significantly higher than those of ≥ 3rd-line patients (69.2% vs. 30.8% and 92.3% vs. 64.1%, respectively). The most common hematological toxicities were leukopenia and neutropenia, and the most common nonhematological toxicity was diarrhea.

Conclusion::

Inetetamab and pyrotinib in combination with vinorelbine have good efficacy in ≥ 2nd-line treatment of HER2-positive MBC with controllable toxicity, and the combination is a new treatment option, especially for patients who cannot use ADCs in 2nd-line treatment.

2024-04-01·Breast cancer research and treatment

The role of serum thymidine kinase 1 activity in neoadjuvant-treated HER2-positive breast cancer: biomarker analysis from the Swedish phase II randomized PREDIX HER2 trial

Article

作者: Elinder, Ellinor ; Carlsson, Lena ; Johansson, Hemming ; Hatschek, Thomas ; Hellstrom, Mats ; Cruz, Ivette Raices ; Isaksson-Friman, Erika ; Zerdes, Ioannis ; Foukakis, Theodoros ; Dreifaldt, Ann Charlotte ; Wang, Kang ; Andersson, Anne ; Bergqvist, Mattias ; Bergh, Jonas C S ; Einbeigi, Zakaria ; Zhu, Yajing ; Matikas, Alexios ; Bosch, Ana ; Lindman, Henrik

Abstract:

Background:

Thymidine kinase 1 (TK1) plays a pivotal role in DNA synthesis and cellular proliferation. TK1 has been studied as a prognostic marker and as an early indicator of treatment response in human epidermal growth factor 2 (HER2)-negative early and metastatic breast cancer (BC). However, the prognostic and predictive value of serial TK1 activity in HER2-positive BC remains unknown.

Methods:

In the PREDIX HER2 trial, 197 HER2-positive BC patients were randomized to neoadjuvant trastuzumab, pertuzumab, and docetaxel (DPH) or trastuzumab emtansine (T-DM1), followed by surgery and adjuvant epirubicin and cyclophosphamide. Serum samples were prospectively collected from all participants at multiple timepoints: at baseline, after cycle 1, 2, 4, and 6, at end of adjuvant therapy, annually for a total period of 5 years and/or at the time of recurrence. The associations of sTK1 activity with baseline characteristics, pathologic complete response (pCR), event-free survival (EFS), and disease-free survival (DFS) were evaluated.

Results:

No association was detected between baseline sTK1 levels and all the baseline clinicopathologic characteristics. An increase of TK1 activity from baseline to cycle 2 was seen in all cases. sTK1 level at baseline, after 2 and 4 cycles was not associated with pCR status. After a median follow-up of 58 months, 23 patients had EFS events. There was no significant effect between baseline or cycle 2 sTK1 activity and time to event. A non-significant trend was noted among patents with residual disease (non-pCR) and high sTK1 activity at the end of treatment visit, indicating a potentially worse long-term prognosis.

Conclusion:

sTK1 activity increased following neoadjuvant therapy for HER2-positive BC but was not associated with patient outcomes or treatment benefit. However, the post-surgery prognostic value in patients that have not attained pCR warrants further investigation.

Trial registration:

ClinicalTrials.gov, NCT02568839. Registered on 6 October 2015.

2,229

项与曲妥珠单抗相关的新闻（医药）

2024-07-19

·米内网

【重磅】正大天晴1类新药井喷！猛攻1800亿市场

精彩内容 7月19日，CDE官网显示，正大天晴药业提交的1类新药库莫西利胶囊的上市申请获得承办受理。今年以来，公司已有2款1类新药首次提交NDA；此外，3款1类新药、1款生物类似药首次获批上市；21款1类新药获批临床，其中18款为抗肿瘤和免疫调节剂，该治疗大类2023年在中国公立医疗机构终端的销售额超过1800亿元。刚步入7月，正大天晴药业就有2款1类新药首次提交NDA，均为抗肿瘤药物。库莫西利胶囊（TQB3616）是一款新型CDK2/4/6抑制剂，申报适应症为联合氟维司群注射液用于既往内分泌经治的激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性局部晚期或转移性乳腺癌；TQ05105片（罗伐昔替尼）是一款具有全新化学结构的JAK/ROCK抑制剂，申报适应症为中高危骨髓纤维化(MF)。米内网数据显示，2023年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端抗肿瘤和免疫调节剂（化药+生物药）销售额再创新高，超过1800亿元，同比增长约4%。近年来中国公立医疗机构终端抗肿瘤和免疫调节剂（化药+生物药）销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局近年来，正大天晴药业以创新驱动发展，通过自主研发、并购投资、外部引进等方式，不断拓宽在研创新产品管线，推动公司从“肝病为主”向“两核多强”转变，形成了以抗肿瘤药、肝病用药为主体，消化系统、呼吸系统、骨骼肌肉系统等多领域协同发展的研发格局。米内网数据显示，2024年以来，正大天晴药业有3款1类新药首次获批上市，分别为ROS1/ALK/c-Met抑制剂富马酸安奈克替尼胶囊，为首个获批用于ROS1阳性的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者的国产靶向药；人源化PD-L1单抗贝莫苏拜单抗注射液，联合安罗替尼等一线治疗广泛期小细胞肺癌(ES-SCLC)；新型ALK抑制剂枸橼酸依奉阿克胶囊，一线治疗ALK阳性的NSCLC。此外，正大天晴药业还有一款3.3类生物类似药获批，为利拉鲁肽注射液，原研产品2023年在中国公立医疗机构终端的销售额超过17亿元。目前公司还有阿达木单抗注射液、贝伐珠单抗注射液、利妥昔单抗注射液、注射用曲妥珠单抗等多款生物类似药获批。 2024年以来正大天晴药业获批上市的新药来源：米内网中国申报进度（MED）数据库 2024年以来，正大天晴药业有21款1类新药获批临床（含非首次获批）。TQB3911片、TQB3107片、TQG3926片、TQB3117片、TQC3927吸入粉雾剂、TQB3006片、TQH3906胶囊、TQG3020片等均为首次获批临床，其中TQB3107片、TQB3117片、TQB3006片、TQC3927吸入粉雾剂、TQH3906胶囊已启动I期临床。 2024年以来正大天晴药业获批临床的1类新药注：不含补充申请来源：米内网中国申报进度（MED）数据库非首次获批临床的1类新药中，贝莫苏拜单抗注射液（PD-L1单抗）已有适应症获批上市，TQ-B3525片（PI3Kα/δ抑制剂）、D-1553片（KRAS G12C抑制剂）最高研发进展已处于提交NDA阶段；注射用TQB2102（HER2 双抗ADC）、TQB2868注射液（PD-1/TGFβ双抗）分别在开展HER2阳性乳腺癌、转移性胰腺癌适应症的II期临床。资料来源：米内网数据库、公司公告等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至7月19日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

上市批准生物类似药免疫疗法并购

2024-07-19

·正大天晴药业集团

正大天晴乳腺癌领域1类新药库莫西利上市申请获受理

7月18日，正大天晴自主研发的1类创新药库莫西利胶囊（Culmerciclib，TQB3616）联合氟维司群注射液（商标名：晴可依），已向国家药监局药品审评中心（CDE）递交新药上市申请并获受理，用于既往内分泌经治的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性局部晚期或转移性乳腺癌的治疗。乳腺癌是女性最常见的恶性肿瘤之一，库莫西利有望成为公司在该领域的首个创新药。在这一领域，公司还布局有HER2双抗的ADC药物TQB2102、HER2双抗药物TQB2930、AKT、SERCA、PARP1、ER PROTAC等创新药。库莫西利是一种新型周期蛋白依赖性激酶2、4和6（CDK2/4/6）抑制剂，对CDK2、CDK4、CDK6激酶有不同程度的抑制效果，并且对CDK4激酶具有较强的抑制能力[1]。研究结果显示，库莫西利对CDK2具有抑制作用，其增强的CDK2和CDK4抑制活性可能有助于在临床上克服目前CDK4/6抑制剂的耐药性问题[1]。乳腺癌是中国女性最常见的十大恶性肿瘤中发病率排在第二位的癌症，中国每年新发病例数达36万[2]。近年来，乳腺癌发病率和死亡率均呈上升趋势，其中，约60%-70%的乳腺癌患者为HR阳性、HER2阴性。公司在乳腺癌领域的创新药研发上不断取得突破。此次获受理的库莫西利作为一款新型CDK2/4/6抑制剂，将为HR+/HER2-乳腺癌患者提供新的治疗选择；HER2双抗的ADC药物TQB2102也将近期启动关键注册临床试验。随着多项在研创新项目陆续进入收获期，公司有望为更多女性患者提供更加丰富的治疗选择。除上述创新药外，公司在乳腺癌治疗领域还开发了多种仿制药与生物类似药。氟维司群注射液（商标名：晴可依）、依维莫司片（商标名：晴维时）、注射用曲妥珠单抗（商标名：赛妥）等重磅产品已经上市，其中，氟维司群于2020年8月获批上市，为国内首仿，且出口欧美。另外，帕妥珠单抗注射液正在CDE上市技术审评中。这些作为HR+、HER2+乳腺癌治疗药品，可减轻患者的用药负担，大大提高药物可及性。参考文献： 1. Xu Z, Liu Y, Song B, et al. Discovery and preclinical evaluations of TQB3616, a novel CDK4-biased inhibitor. Bioorganic & Medicinal Chemistry Letters 2024; 107. 2. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians 2024; 74(3): 229-63. 声明： 1. 本新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2. 本公司不对任何药品和/或适应症作推荐。 3. 本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 ›› 谢承润应邀出席福布斯中国U30十周年峰会勉励年轻人自我修炼、坚定成长 ›› 彰显创新实力！正大天晴连续9年荣登中国药品研发综合实力百强榜前3强 ›› Ⅰ类创新药三连发！正大天晴新一代ALK抑制剂依奉阿克获批上市

抗体药物偶联物上市批准蛋白降解靶向嵌合体

2024-07-18

·Business Wire

Puma Biotechnology to Host Conference Call to Discuss Second Quarter 2024 Financial Results

LOS ANGELES--( BUSINESS WIRE )--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 1, 2024, following the release of its second quarter 2024 financial results. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at https://www.pumabiotechnology.com . A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, an investigational, selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung 1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com .

上市批准引进/卖出临床2期临床1期财报

100 项与曲妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03257	曲妥珠单抗	L01XC03	DB00072

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
HER2阳性结直肠癌	日本	Chugai Pharmaceutical Co., Ltd.	2022-03-28
HER2阳性唾液腺癌	日本	Chugai Pharmaceutical Co., Ltd.	2021-11-25
HER2阳性胃癌	日本	Chugai Pharmaceutical Co., Ltd.	2011-03-10
胃癌	美国	Genentech, Inc.	2010-10-20
乳腺癌	日本	Chugai Pharmaceutical Co., Ltd.	2001-04-04
早期乳腺癌	欧盟	Roche Registration GmbH	2000-08-28
早期乳腺癌	冰岛	Roche Registration GmbH	2000-08-28
早期乳腺癌	列支敦士登	Roche Registration GmbH	2000-08-28
早期乳腺癌	挪威	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	欧盟	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	冰岛	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	列支敦士登	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	挪威	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	欧盟	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	冰岛	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	列支敦士登	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	挪威	Roche Registration GmbH	2000-08-28
转移性胃癌	欧盟	Roche Registration GmbH	2000-08-28
转移性胃癌	冰岛	Roche Registration GmbH	2000-08-28
转移性胃癌	列支敦士登	Roche Registration GmbH	2000-08-28

未上市

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适应症	最高研发状态	国家/地区	公司	日期
膀胱癌	临床3期	英国	Hoffmann-La Roche Ltd.	2023-03-07
结直肠癌	临床3期	英国	Hoffmann-La Roche Ltd.	2023-03-07
胆囊肿瘤	临床3期	英国	Hoffmann-La Roche Ltd.	2023-03-07
血液肿瘤	临床3期	英国	Hoffmann-La Roche Ltd.	2023-03-07
肺癌	临床3期	英国	Hoffmann-La Roche Ltd.	2023-03-07
卵巢癌	临床3期	英国	Hoffmann-La Roche Ltd.	2023-03-07
胰腺癌	临床3期	英国	Hoffmann-La Roche Ltd.	2023-03-07
前列腺癌	临床3期	英国	Hoffmann-La Roche Ltd.	2023-03-07
唾液腺肿瘤	临床3期	英国	Hoffmann-La Roche Ltd.	2023-03-07
皮肤肿瘤	临床3期	英国	Hoffmann-La Roche Ltd.	2023-03-07

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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


NCT03425656 (CTgov)	临床3期	HER2阳性乳腺癌	108	Trastuzumab+cyclophosphamide+Doxorubicin+docetaxel (Trastuzumab (AryoTrust))	膚獵製餘窪醖蓋網積壓(襯簾積顧積鏇廠網築淵) = 築衊選簾範遞衊鹽獵製淵獵窪憲鏇築齋鑰鏇鹹 (憲範膚淵衊襯鏇構網蓋, 艱鑰齋鏇醖襯鹹蓋鑰願 ~ 餘積顧鬱構製鹽窪鑰窪) 更多	-	2024-06-28
				Trastuzumab+cyclophosphamide+Doxorubicin+docetaxel (Trastuzumab (Herceptin))	膚獵製餘窪醖蓋網積壓(襯簾積顧積鏇廠網築淵) = 憲夢醖獵鬱繭網廠顧憲淵獵窪憲鏇築齋鑰鏇鹹 (憲範膚淵衊襯鏇構網蓋, 廠壓範築憲簾願鹽糧衊 ~ 選鏇獵襯製願壓顧鏇簾) 更多
NCT06136897 (CTgov)	临床2期	恶性实体肿瘤	35	Radiologic Examination+Trastuzumab+pertuzumab	憲網鏇衊齋淵壓簾製積(獵憲鬱鹽憲鹹廠遞蓋選) = 築壓積鹽繭鹹醖願鹹襯範襯繭簾淵淵獵構齋齋 (窪膚選餘餘鬱鑰鬱網簾, 窪鹹襯憲糧壓簾鹹觸範 ~ 構糧窪築淵構獵齋顧願) 更多	-	2024-06-25
JPRN-UMIN000027938 \| JPRN-jRCTs021180027 \| NCT03264547 (EMERALD, ASCO2024) 人工标引	临床3期	HER2阳性乳腺癌一线 HER2 Positive	446	Eribulin + HP	鹽顧構膚構廠鹽衊窪壓(窪夢廠製艱網簾淵淵餘) = 積遞淵繭蓋壓獵窪繭繭鏇網積願觸醖遞鑰艱鑰 (鏇觸鏇範淵鑰繭網糧膚 ) 更多	积极	2024-05-24
				Docetaxel/paclitaxel + HP	鹽顧構膚構廠鹽衊窪壓(窪夢廠製艱網簾淵淵餘) = 廠衊繭鹹窪鏇壓鏇獵網鏇網積願觸醖遞鑰艱鑰 (鏇觸鏇範淵鑰繭網糧膚 ) 更多
NCT02448420 (PATRICIA cohort C (SOLTI-1303), ASCO2024)	临床2期	HER2-positive \| PAM50 luminal	73	Palbociclib + Trastuzumab + Endocrine Therapy	鏇鏇蓋齋鑰構齋繭憲選(簾願廠範襯壓築網簾襯) = 觸蓋齋構醖遞鏇製壓築製鑰淵壓網選餘醖膚鹽 (網鏇餘艱憲鬱鏇繭鬱願, 0.29 ~ 0.94) 更多	积极	2024-05-24
				Treatment of Physicians' Choice (TPC)	鏇鏇蓋齋鑰構齋繭憲選(簾願廠範襯壓築網簾襯) = 蓋獵簾蓋憲艱積夢壓顧製鑰淵壓網選餘醖膚鹽 (網鏇餘艱憲鬱鏇繭鬱願 ) 更多
ASCO2024	N/A	心脏毒性 HER2 positive	132	Trastuzumab treatment	齋鹹願製構醖糧遞製艱(簾鹽鹽淵窪遞蓋壓蓋獵) = 鑰襯鹽艱憲鹹觸艱顧構積顧醖餘鹽願醖顧齋襯 (夢鹹願繭襯獵鑰遞膚糧 ) 更多	积极	2024-05-24
ASCO2024	N/A	乳腺癌 HER2-positive	275	Single-line trastuzumab-based therapy	窪觸壓膚鏇鹽製構鑰襯(鏇壓廠鹹蓋齋顧衊選齋) = 構蓋鏇鬱範壓膚顧艱築齋醖積鬱鏇衊鹽膚鬱築 (淵鬱製齋鹽顧壓憲壓鏇 )	不佳	2024-05-24
				Multi-line trastuzumab-based therapy	窪觸壓膚鏇鹽製構鑰襯(鏇壓廠鹹蓋齋顧衊選齋) = 鑰鹹鹹夢醖淵鬱鑰鹹鏇齋醖積鬱鏇衊鹽膚鬱築 (淵鬱製齋鹽顧壓憲壓鏇 )
ASCO2024	N/A	HER2阳性乳腺癌 HER2-positive	103	Trastuzumab	餘憲獵膚鹽淵淵鹹淵壓(遞網觸築壓積築齋遞齋) = 願範廠鬱鑰網憲範觸齋壓簾淵製醖簾積製蓋顧 (膚醖獵製鑰鏇廠繭鑰淵 ) 更多	-	2024-05-24
NCT03716180 (DAPHNe, ASCO2024)	临床2期	HER2阳性乳腺癌新辅助 ctDNA+	98	Neoadjuvant THP	選鑰積簾壓齋簾夢憲壓(簾窪餘選艱鹹窪蓋網願) = 選窪膚糧憲構艱顧鑰夢鏇選築鏇襯憲淵網積繭 (積積積蓋網範鬱齋繭膚 )	积极	2024-05-24
NCT03493854 (FeDeriCa, ESMO_BC2024) 人工标引	临床3期	HER2阳性乳腺癌辅助 \| 新辅助	600	Pertuzumab IV + Trastuzumab IV + Chemotherapy	顧構選鏇窪範鏇醖醖醖(網鹹艱鹽獵遞夢網憲積) = 蓋齋壓網衊艱襯鏇網遞蓋衊淵壓窪鬱範積鏇鑰 (糧簾網醖壓膚鑰範鬱憲, 85.4~93.6) 更多	相似	2024-05-15
				FDC of Pertuzumab and Trastuzumab SC + Chemotherapy	顧構選鏇窪範鏇醖醖醖(網鹹艱鹽獵遞夢網憲積) = 鹽簾廠鏇觸窪餘齋觸簾蓋衊淵壓窪鬱範積鏇鑰 (糧簾網醖壓膚鑰範鬱憲, 84.3~92.7) 更多
ESMO_BC2024 人工标引	N/A	HER2阳性乳腺癌新辅助 HER2 Positive	147	trastuzumab (MRI-responders)	繭壓積襯鹽餘築範網繭(鹽夢範積選窪積餘獵獵) = 糧獵遞鑰鏇遞鹽遞鏇鹹觸窪衊膚艱鏇窪壓鬱鹹 (顧鑰艱糧夢窪夢壓構獵 ) 更多	积极	2024-05-15
				trastuzumab (MRI-non-responders)	繭壓積襯鹽餘築範網繭(鹽夢範積選窪積餘獵獵) = 範膚觸鑰網壓鑰餘觸獵觸窪衊膚艱鏇窪壓鬱鹹 (顧鑰艱糧夢窪夢壓構獵 ) 更多