Datroway Approved in EU for TNBC Treatment

AstraZeneca PLC announced that Datroway (datopotamab deruxtecan) has received European Union approval as a monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. This approval, based on the TROPION-Breast02 Phase III trial, demonstrates a significant improvement in overall survival and progression-free survival compared to chemotherapy. Datroway is now approved for two breast cancer indications in the EU and has shown a median overall survival of 23.7 months versus 18.7 months with chemotherapy. The drug also showed a 43% reduction in the risk of disease progression or death and a higher objective response rate. This marks a significant advancement for patients with this aggressive form of breast cancer, particularly for those who cannot receive immunotherapy.