The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for DATROWAY® (datopotamab deruxtecan), a TROP2-directed antibody-drug conjugate (ADC).
The application seeks approval for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitor therapy.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for June 2, 2026.
The submission is supported by data from the pivotal TROPION-Breast02 Phase 3 trial.
In the study, DATROWAY demonstrated a statistically significant 5-month improvement in median overall survival (OS) compared to physician’s choice of chemotherapy.
Results showed a 43% reduction in the risk of disease progression or death, with an objective response rate (ORR) of 62.5%—more than double the 29.3% seen in the chemotherapy arm.
“DATROWAY potentially could be the first medicine approved in the first-line setting to significantly extend overall survival compared to chemotherapy in patients with metastatic TNBC for whom immunotherapy was not an option,” said Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo.