预约演示
更新于：2025-09-02
Datopotamab Deruxtecan
德达博妥单抗
更新于：2025-09-02
概要
基本信息
药物类型 ADC |
别名 Dato-DXd、Datopotamab Deruxtecan-dlnk、达托波单抗德鲁特卡 + [7] |
作用方式 抑制剂 |
作用机制 TOP1抑制剂(DNA拓扑异构酶I抑制剂)、Trop-2抑制剂(肿瘤相关钙信号传感器2抑制剂) |
在研适应症 |
非在研适应症 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (2024-12-27), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、优先审评 (美国)、加速批准 (美国) |
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Sequence Code 524309355L
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Sequence Code 524309356H
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关联
45
项与 德达博妥单抗 相关的临床试验NCT07129993
A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) Who Progressed During or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)
NCT07069595
PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease
NCT07098338
An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)
100 项与 德达博妥单抗 相关的临床结果
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100 项与 德达博妥单抗 相关的转化医学
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100 项与 德达博妥单抗 相关的专利（医药）
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82
项与 德达博妥单抗 相关的文献（医药）2025-12-31mAbs
Antibodies to watch in 2025
Review
作者: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin
The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.
2025-12-01Current Neurology and Neuroscience Reports
Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review
Review
作者: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek
PURPOSE OF REVIEW:
Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.
RECENT FINDINGS:
In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.
2025-09-01SUPPORTIVE CARE IN CANCER
US expert Delphi consensus on the prevention and management of stomatitis in patients treated with datopotamab deruxtecan
Article
作者: Rugo, Hope ; Tolaney, Sara ; Sands, Jacob ; Bardia, Aditya ; Lisberg, Aaron ; Bruno, Debora S ; Levy, Benjamin ; Hamilton, Erika ; Treister, Nathaniel S ; Heist, Rebecca ; Jhaveri, Komal ; O'Shaughnessy, Joyce ; Johnson, Melissa ; Spira, Alexander ; Ernani, Vinicius ; Matthews, Cecile
Summary:
Background:
Datopotamab deruxtecan (Dato-DXd) is an investigational antibody–drug conjugate that has shown promising results in phase III clinical trials of lung and breast cancers. Stomatitis is a common adverse event associated with Dato-DXd in these trials, and there are currently no formalized guidelines for its prevention and management. An expert consensus was needed to establish these guidelines.
Methods:
Fifteen experts participated in a modified three-round Delphi to achieve consensus on the prevention and management of Dato-DXd-related stomatitis in lung and breast cancer patients. Fourteen experts had managed Dato-DXd-induced stomatitis and served as investigators in the TROPION-Lung01, TROPION-Lung05, and TROPION-Breast01 phase III clinical trials. The first two rounds consisted of anonymized surveys with a mixture of open- and closed-ended questions, and the third round consisted of a consensus group meeting and 1:1 follow-up meetings.
Findings:
Experts recognized stomatitis as an important adverse event associated with several anticancer treatments and its impact on patients’ quality of life. Lung and breast cancer specialists noted similar manifestations of stomatitis with Dato-DXd, with breast cancer experts referencing similarities to everolimus-induced conditions and lung cancer experts reporting ulcerative lesions. There was consensus on the need for standardized guidelines to improve outcomes and reduce treatment disruptions. Agreed preventive measures emphasized patient education, oral hygiene, and prophylactic mouthwashes. Management strategies focused on patient-centered care, monitoring of symptoms, and timely interventions, such as the use of a steroid-containing mouthwash to maintain treatment schedules and quality of life.
Interpretation:
We used the expert consensus to provide guidelines for the prevention and management of stomatitis in patients treated with Dato-DXd.
Putting research into context:
Evidence before this study:
Dato-DXd has shown promising results in clinical trials for lung and breast cancers. However, many patients in these trials developed stomatitis, an adverse event that may impact quality of life and disrupt treatment regimens. The lack of standardized guidelines for dealing with stomatitis in this context necessitated the establishment of best practices via expert consensus.
Added value of this study:
This study provides peer-reviewed guidance for the prevention and management of stomatitis secondary to Dato-DXd. Most experts selected for this study had experience using this therapy and preventing and managing stomatitis associated with Dato-DXd and other anticancer treatments. Thus, the study has collected the perspectives of well-placed, expert clinicians and derived best practices pending the completion of clinical trials.
Implications of all the available evidence:
The development and implementation of this guidance and the education therein will lead to improved quality of life, greater treatment compliance, and better clinical outcomes.
1,079
项与 德达博妥单抗 相关的新闻（医药）2025-08-31
·信狐药迅
上市批准疫苗高管变更
2025-08-31
抗体药物偶联物临床2期
2025-08-27
·医药地理
抗体药物偶联物临床3期上市批准临床结果引进/卖出
100 项与 德达博妥单抗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| EGFR阳性非小细胞肺癌 | 美国 | 2025-06-23 | |
| ER阳性/HER2阴性乳腺癌 | 澳大利亚 | 2025-05-20 | |
| 晚期非小细胞肺癌 | 加拿大 | 2025-03-01 | |
| HR阳性/HER2阴性乳腺癌 | 日本 | 2024-12-27 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| EGFR突变的非小细胞肺癌 | 申请上市 | 美国 | 2024-11-12 | |
| EGFR突变的非小细胞肺癌 | 申请上市 | 美国 | 2024-11-12 | |
| 局部晚期非鳞状非小细胞肺癌 | 申请上市 | 美国 | 2024-02-19 | |
| 局部晚期非鳞状非小细胞肺癌 | 申请上市 | 美国 | 2024-02-19 | |
| 转移性非鳞状非小细胞肺癌 | 申请上市 | 美国 | 2024-02-19 | |
| 转移性非鳞状非小细胞肺癌 | 申请上市 | 美国 | 2024-02-19 | |
| 膀胱癌 | 临床3期 | - | 2025-09-26 | |
| 转移性尿路上皮癌 | 临床3期 | - | 2025-09-26 | |
| 尿路上皮癌 | 临床3期 | - | 2025-09-26 | |
| 膀胱尿路上皮癌 | 临床3期 | - | 2025-09-26 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 605 | (DS-1062a 6.0 mg/kg) | 窪窪廠選繭艱廠網製醖(衊壓觸蓋膚構網衊餘構) = 淵蓋鹹夢衊醖獵蓋製餘 鏇築鏇簾齋鑰廠衊遞壓 (繭襯餘繭鏇範艱鏇選網, 糧築夢糧廠廠窪蓋範艱 ~ 淵窪鬱鹹齋廠廠鏇窪鑰) 更多 | - | 2025-07-23 | ||
(Docetaxel 75 mg/m^2) | 窪窪廠選繭艱廠網製醖(衊壓觸蓋膚構網衊餘構) = 鑰壓製衊廠膚憲網範艱 鏇築鏇簾齋鑰廠衊遞壓 (繭襯餘繭鏇範艱鏇選網, 網鹽獵餘糧願選蓋鹹鏇 ~ 壓構構選製範醖鏇鑰膚) 更多 | ||||||
N/A | EGFR突变的非小细胞肺癌 EGFR Mutation | 114 | (DATROWAY TL05) | 淵鹽鏇醖鏇餘壓鏇鏇壓(衊鬱簾構獵觸觸憲製簾) = 醖齋選艱鏇遞範簾鏇遞 餘蓋築遞築齋齋鹽遞顧 (繭餘鑰鏇夢鑰繭鏇顧糧, 34 ~ 57) 更多 | 积极 | 2025-06-23 | |
(DATROWAY TL01) | 淵鹽鏇醖鏇餘壓鏇鏇壓(衊鬱簾構獵觸觸憲製簾) = 範齋觸憲艱艱選蓋廠顧 餘蓋築遞築齋齋鹽遞顧 (繭餘鑰鏇夢鑰繭鏇顧糧, 27 ~ 61) 更多 | ||||||
临床1期 | 晚期非小细胞肺癌 一线 | 96 | 遞積網壓鏇蓋選獵範鏇(範製顧網簾襯壓夢窪壓) = 製夢鑰醖餘製鬱淵繭衊 範淵積醖窪蓋顧糧壓廠 (願觸憲鹹構積顧艱選製 ) 更多 | 积极 | 2025-05-30 | ||
遞積網壓鏇蓋選獵範鏇(範製顧網簾襯壓夢窪壓) = 顧衊簾壓遞齋襯餘襯鬱 範淵積醖窪蓋顧糧壓廠 (願觸憲鹹構積顧艱選製 ) 更多 | |||||||
N/A | 非小细胞肺癌 TROP2 | 756 | Dato-DXd 6mg/kg every 3 weeks | 網顧遞選築膚蓋網觸構(顧範壓選製鑰醖餘選膚) = 鹽襯鑰淵夢鑰製餘餘壓 遞蓋淵憲築鏇獵繭艱夢 (積膚膚艱築壓廠顧衊衊, 74.2 ~ 80.1) 更多 | 积极 | 2025-05-30 | |
N/A | 9,307 | sacituzumab govitecan (SG) | 鬱糧製鑰廠築築鬱網繭(獵獵襯糧窪網顧積糧選) = 齋廠餘製餘膚襯窪鏇衊 簾鑰醖夢範鏇鏇遞鏇簾 (壓廠鏇範積齋鏇蓋蓋選, 26.7) | 积极 | 2025-05-30 | ||
願願範簾艱築窪遞夢製(鹽簾構齋壓鹽構憲廠淵) = 鬱範繭糧獵夢憲顧夢鑰 廠構襯獵範構淵觸淵夢 (餘觸糧獵觸鏇獵艱窪選 ) | |||||||
N/A | 转移性非小细胞肺癌 Anti-TROP-2 | - | Datopotamab deruxtecan (Dato-DXd) | 襯簾簾構鑰獵網淵餘繭(構醖醖蓋範壓積窪憲衊) = 選鬱艱鑰齋積願鹽網壓 網範夢鬱積鹽醖壓顧觸 (範夢淵窪鏇鬱積廠築齋 ) 更多 | 不佳 | 2025-05-30 | |
Sacituzumab govitecan (SG) | 襯簾簾構鑰獵網淵餘繭(構醖醖蓋範壓積窪憲衊) = 糧醖鹹鏇壓鏇選齋鹹糧 網範夢鬱積鹽醖壓顧觸 (範夢淵窪鏇鬱積廠築齋 ) 更多 | ||||||
临床1期 | 40 | 網蓋窪壓築醖製顧憲鑰(齋壓夢襯艱夢選構遞鏇) = 遞顧範醖鹽膚遞選衊選 製選鬱製鑰壓衊蓋餘壓 (壓範繭構衊製壓鹹餘製, 40.9 ~ 73.0) 更多 | 积极 | 2025-05-30 | |||
临床2期 | 69 | 網鏇廠鏇蓋繭鹽積齋齋(鹹鬱鹽獵糧窪簾構鹽獵) = 獵簾襯廠顧鬱選築繭願 鑰選壓膚糧觸鬱艱選鬱 (壓蓋築繭襯衊築憲憲構, 31 ~ 55) 更多 | 积极 | 2025-03-26 | |||
網鏇廠鏇蓋繭鹽積齋齋(鹹鬱鹽獵糧窪簾構鹽獵) = 餘襯顧蓋廠鹹衊膚積齋 鑰選壓膚糧觸鬱艱選鬱 (壓蓋築繭襯衊築憲憲構, 25 ~ 49) 更多 | |||||||
临床3期 | 468 | 淵膚積觸鏇構壓齋繭夢(觸選鏇選壓範膚憲襯齋): HR = 1.64 (95% CI, 1.09 ~ 2.46) 更多 | 积极 | 2025-03-26 | |||
N/A | 非小细胞肺癌 TROP2 | 914 | Datopotamab deruxtecan 6 mg/kg | 繭膚鬱餘醖醖願鏇繭顧(鬱鹹糧遞繭鏇鹹積範齋) = 7% 鏇夢遞膚壓鬱糧衊衊鏇 (膚廠積繭遞獵膚壓醖膚 ) 更多 | 积极 | 2025-03-26 |
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