FDA grants Priority Review for AstraZeneca and Daiichi Sankyo's Datroway in metastatic triple-negative breast cancer
The US Food and Drug Administration (FDA) has accepted and granted Priority Review for Datroway, an investigational treatment for patients with metastatic triple-negative breast cancer (TNBC) not eligible for immunotherapy.
AstraZeneca and Daiichi Sankyo's application for datopotamab deruxtecan (Datroway®) has received Priority Review from the US Food and Drug Administration (FDA). The drug is intended for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
The FDA's Priority Review designation highlights treatments that may offer significant improvements over existing options. A regulatory decision is anticipated in the second quarter of 2026. Currently, chemotherapy is the only approved first-line treatment for this patient population, which comprises approximately 70% of those with metastatic TNBC.
The application is supported by data from the TROPION-Breast02 Phase III trial. In the study, Datroway demonstrated a statistically significant improvement in overall survival compared to chemotherapy. The drug also nearly doubled the time without disease progression or death in this patient group.
Significance for patients: Triple-negative breast cancer is an aggressive form of the disease with a challenging prognosis. New treatment options are crucial for patients who cannot receive immunotherapy. Datroway could potentially establish a new standard of care in this setting.