Daiichi Sankyo Company, Limited — Datroway EMA EPAR public assessment report (EMEA/H/C/006547, 2025)
Daiichi Sankyo Company, Limited · 2025 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the marketing authorization application for Datroway (datopotamab deruxtecan) by Daiichi Sankyo Europe GmbH. Datroway, a TROP2-directed antibody-drug conjugate, is intended for adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who have progressed on endocrine therapy and received at least one additional systemic therapy. The report details the manufacturing, quality control, and characterization of the active substance and drug-linker. Non-clinical studies confirmed its mechanism of action, anti-tumor activity, and identified genotoxic potential of the DXd component and target organ toxicities. Pharmacokinetic and toxicology studies in animals highlighted tissue distribution, metabolism, and repeat-dose toxicity. Bioanalytical methods and pharmacokinetic modeling were discussed, with a dose cap recommendation for patients ≥90 kg to mitigate adverse events. The pivotal Phase III TROPION-Breast01 study evaluates Datroway against chemotherapy.
Key findings — cited to the page
| IC50 cell viability of DXd in 3T3 fibroblasts with UV-A irradiation | 2.356 µg/mL | · p.52 |
| MPE of DXd in 3T3 fibroblasts with UV-A irradiation | 0.432 | · p.53 |
| Prevalence of ER+/HER2- breast cancer patients | 1497 | · p.10 |
| Percentage of all new cancers that are female breast cancer | 11.7 % | Global · p.10 |
| Estimated breast cancer diagnoses in Europe in 2020 | 531,000 | Europe · p.10 |
| Estimated breast cancer deaths in Europe in 2020 | 141,765 | Europe · p.10 |
| Application submission date | 12 February 2024 | Datroway · p.8 |
| New cases of female breast cancer globally in 2020 | 2.3 million | Global · p.10 |
| Proposed indication | treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have progressed on and are not suitable for endocrine therapy and received at least one additional systemic therapy for unresectable or metastatic disease | Datroway · p.8 |
| EMA Decision on Paediatric waiver | EMEA-002976-PIP02-21 | · p.8 |
| CHMP positive opinion date | 30 January 2025 | Datroway · p.10 |
| Deaths from cancer globally in 2020 due to breast cancer | 685,000 | Global · p.10 |
Source: Daiichi Sankyo Company, Limited ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →