Regulatory PathRegulatory requirements compared

Active substance

Datopotamab deruxtecan

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
DATROWAY100MGinjectable · iv (infusion)DAIICHI SANKYO INCPrescription17 Jan 2025
DATROWAY100MGinjectable · injectionDAIICHI SANKYO INCPrescription23 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.

Datopotamab deruxtecan Daiichi Sankyo Daiichi Sankyo Europe GmbH · Application withdrawn · ATC L01FX35

Therapeutic indication (EMA)

Treatment of adult patients with locally advanced or metastatic non squamous non-small cell lung cancer (NSCLC)

Safety signals and safety-related labeling changes

All safety entries for datopotamab deruxtecan →

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.