June 30, 2025—Datroway (datopotamab deruxtecan-dlnk) has been approved in the United States for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR).
The approval follows priority review and breakthrough therapy designation by the FDA based on subgroup results from the TROPION-Lung05 phase two and TROPION-Lung01 phase three trials. In those trials, Datroway demonstrated a confirmed ORR of 45 percent (95 percent confidence interval [CI], 35–54) in patients (n=114) with previously treated locally advanced or metastatic EGFR-mutated NSCLC, as assessed by blinded independent central review. Complete responses were seen in 4.4 percent of patients and partial responses were seen in 40 percent of patients. The median DoR was 6.5 months (95 percent CI, 4.2–8.4).
Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.