Prodotti competitors / Area Oncology
Datroway approved in the EU for first-line treatment of metastatic TNBC patients ineligible for immunotherapy
On 31 July 2026 the European Commission has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is based on results from the Phase III TROPION-Breast02 trial. Datroway becomes the only TROP2-directed antibody-drug conjugate (ADC) approved in the European Union to demonstrate an overall survival benefit in the first-line treatment setting for metastatic TNBC.
In TROPION-Breast02, which enrolled 644 patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option, Datroway met both dual primary endpoints of overall survival (OS) and progression-free survival (PFS). The treatment demonstrated a statistically significant 5.0-month improvement in median OS compared with investigator’s choice chemotherapy (23.7 months versus 18.7 months; HR 0.79; 95% CI 0.64-0.98; p=0.0291).
Datroway also reduced the risk of disease progression or death by 43% versus chemotherapy (HR 0.57; 95% CI 0.47-0.69; p<0.0001), with an objective response rate of 62.5% compared with 29.3% for chemotherapy. The safety profile observed in the study was consistent with previous Datroway clinical trials in breast cancer.
Based on these results, Datroway has been incorporated into the ESMO Clinical Practice Guidelines as a Category IA first-line treatment option for patients with metastatic TNBC who are not eligible for immunotherapy and is identified as the preferred option for patients relapsing within six months of completing adjuvant therapy. The therapy also received a score of 4 out of 5 on the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS).
Datroway was previously approved in the United States in May 2026 for the same indication.
Regulatory reviews are ongoing in several additional jurisdictions, including China, Japan, Australia, Canada, Singapore and Switzerland through Project Orbis.
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