AstraZeneca's Datroway Breast Cancer Treatment Gets Recommendation for EU Approval
MT Newswires Live
Jun 26
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.
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