Biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (NYSE: AZN), announced on Monday that together with Daiichi Sankyo Company Limited, it has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for Datroway (datopotamab deruxtecan) as a first-line monotherapy for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for immunotherapy.

The recommendation is based on the TROPION-Breast02 Phase III trial, in which Datroway demonstrated a statistically significant and clinically meaningful improvement in overall survival and progression-free survival versus chemotherapy, including a 5.0-month increase in median overall survival. The trial also showed a 43% reduction in risk of disease progression or death and higher objective response rates compared with standard chemotherapy.

If approved, Datroway would become the first TROP2-directed antibody drug conjugate in the European Union with a demonstrated overall survival benefit in this setting.

Datroway is already approved in the US for metastatic triple-negative breast cancer and in additional indications across multiple regions, with a broader global development programme underway across more than 20 clinical trials in oncology.