September 2026—The FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. Efficacy was evaluated in Tropion-Breast02, a multicenter, open-label, randomized trial of 644 patients with unresectable or metastatic triple-negative breast cancer who had not received prior chemotherapy or other systemic anticancer therapy for unresectable or metastatic breast cancer and who were not candidates for PD-1/PD-L1 inhibitor therapy. Patients were randomized (1:1) to receive either datopotamab deruxtecan-dlnk (n = 323) or chemotherapy (n = 321). Median progression-free survival was 10.8 months (95 percent CI, 8.6–13.0) in the datopotamab deruxtecan-dlnk arm and 5.6 months (95 percent CI, 5.0–7.0) in the chemotherapy arm (hazard ratio, 0.57 [95 percent CI, 0.47–0.69]; P<0.0001). Median overall survival was 23.7 months (95 percent CI, 19.8–25.6) and 18.7 months (95 percent CI, 16.0–21.8) in the respective arms (HR, 0.79 [95 percent CI, 0.64–0.98]; P = 0.0290). Confirmed overall response rate was 64 percent (95 percent CI, 58–69) and 30 percent (95 percent CI, 25–36), respectively.
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