The FDA has approved Datroway (datopotamab deruxtecan-dlnk, Dato-DXd) for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval is based on results from the phase 3 TROPION-Breast02 trial.
Dato-DXd significantly improved outcomes compared with standard chemotherapy. Median overall survival reached 23.7 months versus 18.7 months with chemotherapy, while progression-free survival nearly doubled to 10.8 months compared with 5.6 months. The treatment also achieved a 64% response rate, more than double the 30% seen with chemotherapy.
Common side effects included stomatitis, nausea, fatigue, alopecia, and dry eye. Serious adverse events occurred in 17% of patients, including rare interstitial lung disease.
Experts say the approval offers an important new first-line treatment option for patients with aggressive TNBC.