Datroway wins EU approval for first-line metastatic TNBC

AstraZeneca said on 31 July 2026 that the European Commission approved Datroway (datopotamab deruxtecan) as a single-agent, first-line option for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are ineligible for PD-1/PD-L1 immunotherapy.

The decision followed a positive opinion from the EMA's human medicines committee and rests on the Phase III TROPION-Breast02 trial, whose results were shown at last year's European oncology meeting and later published in a medical oncology journal.¹

In the trial, Datroway showed a statistically significant and clinically meaningful 5.0-month improvement in median overall survival compared with chemotherapy in the first-line setting, with median survival of 23.7 months versus 18.7 months (hazard ratio 0.79, 95% CI 0.64-0.98, p=0.0291).¹ On progression-free survival, the drug lowered the risk of disease progression or death by 43% relative to chemotherapy, based on blinded independent central review (hazard ratio 0.57, 95% CI 0.47-0.69, p<0.0001).¹ Response rates also favored Datroway: 62.5% versus 29.3% with chemotherapy.¹

The company said the drug has since been named a Category IA first-line option in ESMO's clinical practice guidelines for this immunotherapy-ineligible population, and scored 4 out of 5 on ESMO's clinical benefit scale.¹ Datroway received the equivalent U.S. approval for this indication in May 2026, and regulatory reviews are ongoing in China, Japan, Australia, Canada, Singapore and Switzerland under Project Orbis.¹

This marks the drug's second approved breast cancer indication in the EU, following its earlier clearance in HR-positive, HER2-negative disease.