Datopotamab deruxtecan
Datopotamab deruxtecan (Datroway, Daiichi Sankyo Europe GmbH) has 2 EU-approved indications in 2 tumour types. 1 needs a biomarker result: Hormone receptor (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Triple-negative breast cancer1 | |||
Triple-negative (ER-negative, PR-negative, HER2-negative) | Monotherapy | 1L advanced | Not candidates for PD-1/PD-L1 inhibitor therapy |
| Breast cancer1 | |||
Hormone receptor-positive, HER2-negative | Monotherapy | 2L advanced | After endocrine therapy and at least one line of chemotherapy in the advanced setting |
Full text of section 4.1 (therapeutic indications)
Breast cancer Datroway as monotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy (see section 5.1). Datroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting (see section 5.1).
Label history
5 changes to the Datroway label since 2026, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes