Datroway (datopotamab deruxtecan) has been recommended for approval in the European Union as monotherapy 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. The positive opinion was issued by the Committee for Medicinal Products for Human Use (CHMP) and will be forwarded to the European Commission, which has final authority on marketing authorizations across the EU.
The recommendation is based on results from a pivotal Phase 3 study comparing Datroway with physician’s‑choice chemotherapy in previously untreated adults with unresectable or metastatic TNBC who were ineligible for immunotherapy. In that study, Datroway improved overall survival, progression‑free survival and objective response rates versus chemotherapy, although specific numerical data were not disclosed in the summary information.
Datroway is a TROP2‑directed antibody‑drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca. If the European Commission grants approval, it would become the first TROP2‑targeting ADC in the EU to provide a survival benefit for patients with metastatic TNBC in the first‑line setting, addressing a population with historically limited treatment options.
Datroway is already authorized in the EU for adults with unresectable or metastatic hormone receptor‑positive, HER2‑negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. The new CHMP opinion for metastatic TNBC would expand its potential use into a second breast cancer subtype, pending the Commission’s final decision.
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