Datroway (datopotamab deruxtecan)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- datopotamab deruxtecan
- Company
- Daiichi Sankyo Europe GmbH
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Thu 30 Jan 2025
- EU approval
- Fri 04 Apr 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006547
- ATC
- L01FX35
- Official record
- www.ema.europa.eu
Indication
Breast cancer 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Datopotamab deruxtecan Daiichi Sankyo Application withdrawn · Daiichi Sankyo Europe GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.