Also known as: Dato-DXd, Datroway
Datopotamab deruxtecan-dlnk is a Trop-2-directed antibody-drug conjugate topoisomerase inhibitor marketed as Datroway for selected advanced breast and lung cancer settings. It received FDA approval in January 2025 for previously treated unresectable or metastatic HR-positive/HER2-negative breast cancer and accelerated approval in June 2025 for EGFR-mutated NSCLC after prior targeted and platinum therapy. It is administered as IV infusion every 3 weeks.
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
Agentic AI models are streamlining oncology clinical trial design and reducing phase II to III failure risk. Separately, Aethlon Medical progresses its Hemopurifier device trial in Australia with strong safety data and accelerated patient recruitment.
The ASCENT-04 trial showed sacituzumab govitecan plus pembrolizumab improved progression-free survival in PD-L1-positive TNBC without increased toxicity. Meanwhile, experts debate whether ADCs function as targeted therapy or advanced chemotherapy, with sequencing questions remaining unresolved.
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
Antibody-drug conjugates targeting TROP2 with topoisomerase I inhibitor payloads are currently marketed in breast and lung cancer, with over 100 such ADCs now in clinical trials for various malignancies including gastrointestinal tumors.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07582887 |
Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response |
RECRUITING | |
| NCT07069595 |
PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease |
RECRUITING | PHASE2 |
| NCT06822543 |
A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer) |
RECRUITING | PHASE2 |
| NCT06676917 |
Datopotamab Deruxtecan (Dato-DXd) for Non-Small Cell Lung Cancer (NSCLC) Patients With Active Brain Metastases |
WITHDRAWN | PHASE2 |
| NCT06564844 |
A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06533826 |
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd |
RECRUITING | PHASE2 |
| NCT06357533 |
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations |
RECRUITING | PHASE3 |
| NCT06350097 |
Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer |
RECRUITING | PHASE3 |
| NCT06279728 |
Medical Access Program for Datopotamab Deruxtecan in EGFRm NSCLC Patients |
APPROVED_FOR_MARKETING | |
| NCT06176261 |
DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs |
RECRUITING | PHASE2 |
