The FDA has accepted a supplemental biologics license application for datopotamab deruxtecan (Dato-DXd) as a first-line treatment for adults with unresectable or metastatic triple-negative breast cancer who cannot receive immunotherapy. A regulatory decision is expected in the second quarter of 2026.
The application is supported by Phase 3 TROPION-Breast02 trial results showing that Dato-DXd outperformed standard chemotherapy across all major outcomes. Patients treated with Dato-DXd lived longer overall (23.7 vs. 18.7 months), had longer progression-free survival (10.8 vs. 5.6 months), and were more than twice as likely to respond to treatment (62.5% vs. 29.3%). Responses also lasted longer, averaging 12.3 months compared with 7.1 months for chemotherapy.
The study enrolled patients with aggressive disease who had not received prior treatment for metastatic TNBC and were not eligible for PD-1/PD-L1 inhibitors. Side effects were consistent with earlier studies, with 33% experiencing serious treatment-related adverse events. The most common side effects included mouth sores, nausea, dry eye, and constipation. If approved, Dato-DXd could become the first first-line therapy to significantly extend overall survival for this patient population.