Drugs / Datopotamab deruxtecan
Datopotamab deruxtecan
also known as
Dato-DXd · Datopotamab deruxtecan (Dato-DXd, DS-1062a) · DS-1062a · ADC DS-1062A · Datopotamab deruxtecan-dlnk · DS-1026a · DS-1062
Monoclonal antibody targets TACSTD2, TOP1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | DATROWAY | — | 2026-05-22 | fda.gov ↗ |
| Approved | EU (EMA) | Datroway | — | 2025-04-04 | europa.eu ↗ |
| Approved | US (FDA) | DATROWAY | — | 2025-01-17 | fda.gov ↗ |
Trials 44 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06244485 | Feb 2024 → Nov 2028 expected | — | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 1 | NCT05117476 | Oct 2021 → Mar 2026 overdue | non-small cell lung carcinoma | Cullinan Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04612751 | Feb 2021 → May 2026 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04526691 | Sep 2020 → Apr 2024 overdue | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03401385 | Jan 2018 → Jan 2027 expected | hormone receptor-positive breast cancer, non-small cell lung carcinoma, triple-negative breast carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT07535437 | Apr 2026 → Apr 2028 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06508216 | Jul 2024 → Dec 2025 overdue | breast cancer | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06130553 | Jan 2024 → Dec 2028 expected | — | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05460273 | Jul 2022 → Nov 2023 overdue | non-small cell lung carcinoma, triple-negative breast carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05417594 | Jun 2022 → Nov 2027 expected | high grade malignant neoplasm | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04644068 | Nov 2020 → May 2027 expected | biliary tract cancer, breast cancer, cervical cancer, colorectal cancer +8 | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03742102 | Dec 2018 → Nov 2024 overdue | triple-negative breast carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 215 trials | ||||||
| Phase 2 | NCT07471776 | Mar 2026 → Mar 2028 expected | Her2-receptor negative breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07069595 | Feb 2026 → Nov 2031 expected | triple-negative breast carcinoma | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06954480 | Oct 2025 → Feb 2028 expected | triple-negative breast carcinoma | Queen Mary University of London | Recruiting | No outcome recorded |
| Phase 2 | NCT06822543 | Sep 2025 → Jun 2028 expected | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Latin American Cooperative Oncology Group | Recruiting | No outcome recorded |
| Phase 2 | NCT07098338 | Aug 2025 → Apr 2029 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT06676917 | Jun 2025 → Aug 2027 | non-small cell lung carcinoma | MedSIR | Withdrawn | No outcome recorded |
| Phase 2 | NCT06533826 | Oct 2024 → Jan 2028 expected | Her2-receptor negative breast cancer | Ana C Garrido-Castro, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06176261 | Jan 2024 → Jan 2028 expected | estrogen-receptor positive breast cancer, female breast carcinoma, triple-negative breast carcinoma | Sarah Sammons, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05866432 | Jul 2023 → May 2026 overdue | breast cancer | Medical University of Vienna | Recruiting | No outcome recorded |
| Phase 2 | NCT05489211 | Sep 2022 → Oct 2027 expected | biliary tract cancer, castration-resistant prostate carcinoma, colorectal cancer, endometrial cancer +3 | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT05061550 | Apr 2022 → May 2030 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT04940325 | May 2021 → Apr 2028 expected | non-small cell lung carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04484142 | Mar 2021 → Mar 2023 | non-small cell lung carcinoma | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT03944772 | Jun 2019 → May 2025 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07129993 | Sep 2025 → Jun 2029 expected | urinary bladder cancer, urothelial carcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 315 trials | ||||||
| Phase 3 | NCT07291037 | Oct 2025 → Jan 2029 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT07205822 | Oct 2025 → Feb 2028 expected | breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06564844 | Oct 2024 → Jun 2027 expected | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06417814 | Oct 2024 → Sep 2026 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06350097 | Apr 2024 → Mar 2028 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06357533 | Apr 2024 → Dec 2029 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06103864 | Nov 2023 → Jul 2027 expected | breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06112379 | Nov 2023 → Nov 2028 expected | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05555732 | Jan 2023 → May 2029 expected | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05687266 | Dec 2022 → Nov 2027 expected | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05629585 | Nov 2022 → Sep 2027 expected | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05374512 | May 2022 → Aug 2025 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05215340 | Mar 2022 → Mar 2030 expected | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05104866 | Oct 2021 → Jul 2024 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04656652 | Dec 2020 → May 2024 overdue | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06279728 | — | lung cancer | Daiichi Sankyo | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT07474558 Background | Sep 2026 → Jan 2030 expected | alopecia, metastatic neoplasm | Jules Bordet Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06974604 Background | Oct 2025 → May 2027 expected | breast neoplasm, lung neoplasm | Brown University | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07357597 Background | Jun 2026 → Jan 2028 expected | stomatitis | AstraZeneca | Recruiting | No outcome recorded |
Press releases naming this drug 25 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-01-17 | AstraZeneca | Datroway (datopotamab deruxtecan) approved in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer astrazeneca.com ↗ |
| 2025-01-13 | AstraZeneca | Datopotamab deruxtecan granted Priority Review in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer astrazeneca.com ↗ |
| 2024-12-24 | AstraZeneca | Datopotamab deruxtecan application in the EU for patients with advanced nonsquamous non-small cell lung cancer voluntarily withdrawn astrazeneca.com ↗ |
| 2024-12-09 | AstraZeneca | Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer astrazeneca.com ↗ |
| 2024-11-12 | AstraZeneca | Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer astrazeneca.com ↗ |
| 2024-09-23 | AstraZeneca | Datopotamab deruxtecan final overall survival results reported in patients with metastatic HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial astrazeneca.com ↗ |
| 2024-09-09 | AstraZeneca | Datopotamab deruxtecan showed median overall survival of 14.6 months in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase III trial astrazeneca.com ↗ |
| 2024-09-08 | AstraZeneca | Novel computational pathology-based TROP2 biomarker for datopotamab deruxtecan was predictive of clinical outcomes in patients with non-small cell lung cancer in TROPION-Lung01 Phase III trial astrazeneca.com ↗ |
| 2024-05-27 | AstraZeneca | Datopotamab deruxtecan showed clinically meaningful overall survival improvement vs. chemotherapy in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase III trial astrazeneca.com ↗ |
| 2024-04-02 | AstraZeneca | Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer astrazeneca.com ↗ |
| 2024-03-04 | AstraZeneca | Two datopotamab deruxtecan applications validated in the EU for patients with advanced nonsquamous non-small cell lung cancer or HR-positive, HER2-negative breast cancer astrazeneca.com ↗ |
| 2024-02-19 | AstraZeneca | Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer astrazeneca.com ↗ |
| 2023-10-23 | AstraZeneca | Datopotamab deruxtecan significantly extended progression-free survival vs. chemotherapy in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial astrazeneca.com ↗ |
| 2023-10-23 | AstraZeneca | Datopotamab deruxtecan improved progression-free survival vs. chemotherapy in patients with previously treated non-small cell lung cancer in TROPION-Lung01 Phase III trial astrazeneca.com ↗ |
| 2023-10-22 | AstraZeneca | Datopotamab deruxtecan plus Imfinzi demonstrated robust and durable tumour responses in 1st-line treatment of patients with metastatic triple-negative breast cancer in BEGONIA Phase Ib/II trial astrazeneca.com ↗ |
| 2021-01-29 | Daiichi Sankyo | Datopotamab Deruxtecan and ENHERTU® Show Promising Early Clinical Activity in Patients with Advanced Non-Small Cell Lung Cancer daiichisankyo.com ↗ |
| 2020-12-15 | Daiichi Sankyo | TROPION-Lung05 Phase 2 Trial of Datopotamab Deruxtecan Initiated in Patients with Advanced or Metastatic NSCLC with Actionable Genomic Alterations daiichisankyo.com ↗ |
| 2020-12-15 | Daiichi Sankyo | TROPION-Lung01 Head-to-Head Phase 3 Trial Initiated to Evaluate Datopotamab Deruxtecan Versus Docetaxel in Previously Treated Patients with Advanced or Metastatic NSCLC Without Actionable Genomic Alterations daiichisankyo.com ↗ |
| 2020-07-27 | Daiichi Sankyo | Daiichi Sankyo and AstraZeneca Enter New Global Development and Commercialization Collaboration for Daiichi Sankyo’s ADC DS-1062 daiichisankyo.com ↗ |
| 2020-07-22 | Daiichi Sankyo | Daiichi Sankyo and Gustave Roussy Enter Innovative Research Collaboration for DXd ADCs DS-1062 and Patritumab Deruxtecan daiichisankyo.com ↗ |
| 2020-07-02 | Daiichi Sankyo | Daiichi Sankyo Expands DS-1062 Study to Include Patients with Triple Negative Breast Cancer daiichisankyo.com ↗ |
| 2020-06-01 | Daiichi Sankyo | Daiichi Sankyo Announces Clinical Research Collaboration to Evaluate DS-1062 in Combination with KEYTRUDA® (pembrolizumab) in Metastatic Non-Small Cell Lung Cancer daiichisankyo.com ↗ |
| 2019-09-10 | Daiichi Sankyo | Updated Clinical Results and New Biomarker Analyses Presented for Daiichi Sankyo’s DS-1062 in Patients with Advanced NSCLC at 2019 World Conference on Lung Cancer daiichisankyo.com ↗ |
| 2019-06-03 | Daiichi Sankyo | Daiichi Sankyo Presents Preliminary Phase 1 Data for TROP2 Targeting ADC DS-1062 in Patients with Non-Small Cell Lung Cancer at 2019 ASCO Annual Meeting daiichisankyo.com ↗ |
| 2018-02-23 | Daiichi Sankyo | Daiichi Sankyo Initiates Phase 1 Study of DS-1062 in Patients with Advanced Non-Small Cell Lung Cancer daiichisankyo.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 52 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Datopotamab Deruxtecan | “Participants with previously treated, locally advanced, unresectable, or metastatic non-squamous non-small cell lung cancer (NSCLC) with or without actionable genomic...” NCT06244485 ↗36“Datopotamab deruxtecan (Dato-DXd), an antibody-drug conjugate comprising a humanized anti-trophoblast cell-surface antigen 2 (TROP 2) monoclonal antibody conjugated to a potent...” PMID 41466843 ↗ Dec 2025 “Datopotamab deruxtecan (Dato-DXd) consists of a TROP2-directed humanized IgG1 monoclonal antibody attached via a serum-stable cleavable linker to a topoisomerase I inhibitor payload.” PMID 37387213 ↗ Jun 2023 “Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases” NCT05866432 ↗ “Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer” NCT04940325 ↗ “Patients in module 1 \& 2 will receive Datopotamab Deruxtecan (Dato-DXd) 6mg/kg every 21 days” NCT06508216 ↗ “Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.” NCT05061550 ↗ “Datopotamab Deruxtecan (Dato-DXd DS-1062a)” NCT06974604 ↗ “datopotamab deruxtecan- (Dato-DXd)” NCT07535437 ↗ |
| Known as | ADC DS-1062A | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297939 ↗ |
| Known as | Dato-DXd | “Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate consisting of a humanized antitrophoblast cell-surface antigen 2 (TROP2) monoclonal antibody linked to a potent,...” PMID 38652877 ↗ Apr 202425“Participants with previously treated, locally advanced, unresectable, or metastatic non-squamous non-small cell lung cancer (NSCLC) with or without actionable genomic...” NCT06244485 ↗ “This study will assess safety and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in...” NCT04526691 ↗ “Datopotamab deruxtecan (Dato-DXd), an antibody-drug conjugate comprising a humanized anti-trophoblast cell-surface antigen 2 (TROP 2) monoclonal antibody conjugated to a potent...” PMID 41466843 ↗ Dec 2025 “Datopotamab deruxtecan (Dato-DXd) is a novel antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 IgG1 monoclonal antibody linked to a topoisomerase I inhibitor...” NCT06822543 ↗ “Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases” NCT05866432 ↗ “Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer” NCT04940325 ↗ “Datopotamab Deruxtecan (Dato-DXd DS-1062a)” NCT06974604 ↗ “Datopotamab deruxtecan-dlnk (Dato-DXd)” NCT05117476 ↗ “Dato-DXd, 6 mg/kg Q3W, IV for 12 weeks” NCT01042379 ↗ “Datopotamab deruxtecan (Dato-DXd)” NCT07291037 ↗ “Datopotamab Deruxtecan (Dato-DXd)” NCT05460273 ↗ “Datopotamab Deruxtecan (Dato-DXd)” NCT07357597 ↗ “Datopotamab Deruxtecan (Dato-DXd)” NCT06954480 ↗ “Datopotamab Deruxtecan (Dato-DXd)” NCT05417594 ↗ |
| Known as | Datopotamab deruxtecan (Dato-DXd, DS-1062a) | “Datopotamab deruxtecan (Dato-DXd, DS-1062a)” NCT05629585 ↗4“Datopotamab deruxtecan (Dato-DXd, DS-1062a)” NCT06103864 ↗ “Datopotamab deruxtecan (Dato-DXd, DS-1062a)” NCT05374512 ↗ “Datopotamab deruxtecan (Dato-DXd, DS-1062a)” NCT05104866 ↗ “Datopotamab deruxtecan (Dato-DXd, DS-1062a)” NCT06112379 ↗ |
| Known as | Datopotamab deruxtecan-dlnk | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05117476 ↗ |
| Known as | DS-1026a | “Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases” NCT05866432 ↗ |
| Known as | DS-1062 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297939 ↗ |
| Known as | DS-1062a | “Datopotamab deruxtecan (DS-1062a) 6.0 mg/kg body weight i.v. on day 1 once every three weeks” NCT05866432 ↗ |
| Action | Deplete | “Datopotamab binds to TROP2, a protein found on breast cancer cells, and is taken into the tumor cell where the linker breaks, releasing DXd to kill the cell.” PMID 38686016 ↗ Apr 2024 |
| Action | Inhibit | “DNA topoisomerase I inhibitor” CHEMBL4297939 ↗ |
| Modality | Other / unclassified | “is a trophoblast cell-surface antigen-2-directed antibody-drug conjugate with a highly potent topoisomerase I inhibitor payload” PMID 39761483 ↗ Jan 2025 |
| Route | Intravenous | “Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w” NCT03742102 ↗ |
| Target | TACSTD2 | “Tumor-associated calcium signal transducer 2 binding agent” CHEMBL4297939 ↗ |
| Target | TOP1 | “DNA topoisomerase I inhibitor” CHEMBL4297939 ↗ |