DATROWAY approved in the EU for patients with previously treated metastatic HR positive, HER2 negative breast cancer

CAR-T Digest - August 2020

08 Apr 2025: DATROWAY approved in the EU for patients with previously treated metastatic HR positive, HER2 negative breast cancer

DATROWAY has been approved in the EU for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer after endocrine therapy and chemotherapy
Approval is based on results from the Phase 3 TROPION-Breast01 trial, where DATROWAY reduced disease progression or death risk by 37% versus chemotherapy
The drug showed better median progression-free survival (6.9 vs 4.9 months) and higher objective response rate (36% vs 23%) than chemotherapy
Grade 3 or higher side effects included stomatitis (3.2%), fatigue (4.3%), and anemia (3.2%), with serious (grade 5) events in 0.7% of patients
DATROWAY addresses a key unmet need in metastatic HR-positive, HER2-negative breast cancer. It provides an alternative where conventional options show limited efficacy