EU approves AstraZeneca and Daiichi Sankyo's (TYO:4568) Datroway as first-line monotherapy for metastatic triple-negative breast cancer patients ineligible for PD-1/PD-L1 inhibitors, according to a statement on Friday.
The decision is based on the TROPION-Breast02 Phase III trial, which demonstrated a 5-month improvement in median overall survival and a 43% reduction in the risk of disease progression or death compared to chemotherapy.
This approval makes Datroway the only TROP2-directed antibody drug conjugate in the EU to show an overall survival benefit in this first-line setting, the statement read.
The therapy, which was previously approved in the US in May, is now recommended in ESMO Clinical Practice Guidelines as a Category IA treatment option for eligible patients.