CHMP backs Datroway for first-line TNBC treatment in EU

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval on 29 June 2026 for Datroway (datopotamab deruxtecan) as monotherapy for first-line treatment of adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.¹

The recommendation rests on the TROPION-Breast02 Phase III trial, with results presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.¹ In the trial, Datroway showed a statistically significant improvement in median overall survival, 23.7 months versus 18.7 months for chemotherapy (hazard ratio 0.79, 95% CI 0.64-0.98, p=0.0291).¹ On progression-free survival, Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy (HR 0.57, 95% CI 0.47-0.69, p<0.0001) as assessed by blinded independent central review.¹ Response rates also favored the drug: objective response rate was 62.5% for Datroway versus 29.3% for chemotherapy.¹

The trial enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America,¹ comparing Datroway to investigator's choice of chemotherapy in previously untreated metastatic TNBC patients for whom immunotherapy was not an option.¹

Datroway already holds US approval in this setting, granted in May 2026, and additional regulatory reviews are underway in China and Japan, as well as Australia, Canada, Singapore and Switzerland through Project Orbis.¹ The companies noted the safety profile in this trial was consistent with prior Datroway studies in breast cancer.