Datopotamab deruxtecan has been recommended for approval in the EU for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer post-endocrine and chemotherapy

The CHMP recommendation is based on the TROPION-Breast01 phase 3 trial, which showed a 37% reduction in progression or death risk versus chemotherapy (HR=0.63 )

Patients treated with datopotamab deruxtecan had a median PFS of 6.9 months versus 4.9 months with chemotherapy, and an ORR of 36% compared to 23% in the chemotherapy arm

The safety profile was favorable, with fewer grade 3 or higher TRAEs (21% vs. 45% with chemotherapy); the most common were neutropenia, stomatitis, fatigue, and anemia