Datroway recommended for EU approval for advanced triple-negative breast cancer

AstraZeneca and Daiichi Sankyo have received a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for datopotamab deruxtecan (Datroway).

The recommendation is for approval as a monotherapy in 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 is based on results from the TROPION-Breast02 Phase III trial. In the study, Datroway demonstrated a statistically significant and clinically meaningful improvement in both overall survival (OS) and progression-free survival (PFS) compared to chemotherapy. The drug reduced the risk of death by 43% and increased median OS by 5 months.

Triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options for metastatic disease, particularly for patients ineligible for immunotherapy. If approved, Datroway could become the first TROP2-directed antibody-drug conjugate (ADC) offering a proven overall survival benefit as a first-line treatment for this patient population in the EU.

Datroway is a TROP2-directed ADC discovered by Daiichi Sankyo. The drug was previously approved in the US in May 2026 for the same indication. Further reviews are ongoing in China and Japan.