Datroway approved in the U.S. as first TROP2-directed ADC for 1L metastatic TNBC patients ineligible for PD-1/PD-L1 inhibitors

CAR-T Digest - August 2020

22 May 2026: Datroway approved in the U.S. as first TROP2-directed ADC for 1L metastatic TNBC patients ineligible for PD-1/PD-L1 inhibitors

AstraZeneca and Daiichi Sankyo have secured U.S. FDA approval for Datroway (datopotamab deruxtecan) as the first TROP2-directed ADC for first-line treatment of metastatic triple-negative breast cancer (TNBC) patients who are not candidates for PD-1/PD-L1 inhibitor therapy, establishing a new targeted treatment option in a population historically reliant on chemotherapy
The approval was supported by results from the Phase 3 TROPION-Breast02 trial, where Datroway became the first and only therapy in this setting to significantly improve overall survival versus chemotherapy, delivering an unprecedented median overall survival of nearly two years
Datroway also demonstrated a 43% reduction in the risk of disease progression or death, along with a strong objective response rate of 64% compared to 30% with chemotherapy, further reinforcing the clinical benefit of the TROP2-directed DXd ADC platform
The approval further strengthens Daiichi Sankyo and AstraZeneca’s leadership in ADC innovation, expanding the commercial footprint of the TROP2 franchise and creating a differentiated position against emerging TROP2-targeted competitors in breast cancer
Strategically, the decision represents a major milestone for the broader TROP2 ADC class, validating targeted ADCs as a frontline treatment approach in metastatic TNBC and accelerating momentum for TROP2-directed development across multiple solid tumor indications