AstraZeneca (AZN) said Friday that Datroway, jointly developed with Daiichi Sankyo, was recommended for European Union approval as a treatment of unresectable or metastatic triple-negative breast cancer patients who are not candidates for immunotherapy.

The recommendation by a European Medicines Agency committee was based on results from a phase 3 trial, where Datroway demonstrated a "statistically significant and clinically meaningful" improvement for the dual primary endpoints of overall survival and progression-free survival, the company said.

The safety profile of Datroway in the trial was consistent with previous studies in breast cancer, according to AstraZeneca.