AstraZeneca (AZN) and Daiichi Sankyo said Friday the European Commission approved Datroway as a first-line monotherapy for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

The companies said the approval was based on the phase 3 trial, which met its primary endpoint of progression-free survival. Datroway extended median overall survival by 5 months to 23.7 months, compared with 18.7 months for chemotherapy.

The treatment also reduced the risk of disease progression or death by 43% and achieved an objective response rate of 62.5%, versus 29.3% with chemotherapy, the companies said.

Datroway was approved in the US for the same indication in May 2026, the companies said, adding that regulatory reviews are ongoing in China, Japan, Australia, Canada, Singapore and Switzerland.