US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
| DATROWAY | 100MG | injectable · iv (infusion) | DAIICHI SANKYO INC | Prescription | 17 Jan 2025 |
| DATROWAY | 100MG | injectable · injection | DAIICHI SANKYO INC | Prescription | 23 Jun 2025 |
EMA European Union — centrally authorised medicines
Datroway Daiichi Sankyo Europe GmbH · Authorised · authorised 4 Apr 2025 · ATC L01FX35
Therapeutic indication (EMA)
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.
Therapeutic indication (EMA)
Treatment of adult patients with locally advanced or metastatic non squamous non-small cell lung cancer (NSCLC)
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.