Datopotamab deruxtecan (Dato-DXd)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-DATOPOTAMAB-DERUXTECAN |
|---|---|
| Type | Drug |
| Aliases | DatrowayДатопотамаб дерукстекан |
| Status | pending_clinical_signoff |
| Diseases | DIS-BREAST DIS-NSCLC |
| Sources | SRC-ESMO-BREAST-METASTATIC-2024 SRC-ESMO-NSCLC-METASTATIC-2024 SRC-NCCN-BREAST-2025 SRC-NCCN-NSCLC-2025 |
Drug Facts
| Class | TROP2-targeted antibody-drug conjugate (deruxtecan / topo-I inhibitor payload) |
|---|---|
| Mechanism | Humanized anti-TROP2 IgG1 monoclonal antibody linked to deruxtecan (DXd, exatecan-derivative topoisomerase-I inhibitor) via cleavable tetrapeptide linker. Drug-to-antibody ratio ~4:1, bystander effect on neighboring TROP2-low cells. TROP2 is broadly expressed on epithelial tumors (breast, NSCLC). |
| Typical dosing | 6 mg/kg IV q3 weeks until disease progression or unacceptable toxicity. Premedication with antiemetics + corticosteroids + ocular lubrication recommended. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-29 |
Notes
TROPION-Breast01 (NCT05104866): Phase III, HR+/HER2- pre-treated metastatic breast cancer. Dato-DXd vs investigator-choice chemo. Median PFS 6.9 vs 4.9 mo (HR 0.63). FDA approval Jan 2025. TROPION-Lung01 (NCT04656652): Phase III, pre-treated advanced NSCLC. Modest PFS benefit overall; greater benefit in non-squamous subset and in actionable-genomic-alteration NSCLC. Stomatitis + ocular toxicity = distinguishing AE profile vs T-DXd. Trial-source SRCs for TROPION-Breast01 and TROPION-Lung01 not yet ingested into KB — FLAG for follow-up.
Used By
Regimens
REG-DATO-DXD-BREAST-2L- Datopotamab deruxtecan (Dato-DXd) monotherapy (HR+/HER2- pre-treated metastatic post-ET +...REG-DATO-DXD-NSCLC-2L- Datopotamab deruxtecan monotherapy (TROPION-Lung01) — 2L+ NSCLC