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.
The application is being reviewed under Project Orbis, an initiative that allows for concurrent submission and review among international regulatory partners to expedite patient access to oncology treatments.
The safety profile remained consistent with earlier trials.
Grade 3 or higher treatment-related adverse events occurred in 33% of patients, with stomatitis and neutropenia being among the most common.
One drug-related Grade 5 interstitial lung disease (ILD) event was reported.
DATROWAY is the latest product of the multi-billion dollar oncology collaboration between AstraZeneca (NYSE:AZN) and Daiichi Sankyo, following the success of ENHERTU.
Slug: FDA-PRIORITY-REVIEW-DATROWAY-AZN-DAIICHI-TNBC