AstraZeneca PLC: Datroway approved in US for 1L triple-negative BC
The FDA has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) as the first TROP2-directed antibody drug conjugate for first-line treatment of metastatic triple-negative breast cancer in patients ineligible for PD-1/PD-L1 inhibitors, based on TROPION-Breast02 Phase III trial results showing a median overall survival of approximately two years. This approval marks a shift from chemotherapy as the sole option for these patients, offering a new standard of care with a 5.0-month survival improvement over chemotherapy.
The U.S. Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan), developed by AstraZeneca and Daiichi Sankyo, 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. This approval follows a Priority Review and is based on results from the TROPION-Breast02 Phase III trial, which demonstrated a median overall survival of approximately two years—a significant improvement over chemotherapy. The trial results were presented at the 2025 European Society for Medical Oncology Congress and published in *Annals of Oncology*. Datroway is the first TROP2-directed antibody drug conjugate to show prolonged overall survival in this patient population compared to chemotherapy. The trial reported a 5.0-month improvement in median overall survival (hazard ratio 0.79) and a 43% reduction in the risk of disease progression or death (hazard ratio 0.57). Additionally, the objective response rate was 64% with Datroway versus 30% with chemotherapy, indicating more robust treatment responses. The safety profile aligns with previous clinical trials of the drug in breast cancer. This approval addresses a critical gap in treatment options for patients with metastatic TNBC who are ineligible for immunotherapy. Chemotherapy has been the only available option for seven out of ten such patients, and Datroway now offers a new standard of care. The drug’s approval was reviewed under Project Orbis, a framework for concurrent submission and review of oncology treatments across multiple countries. AstraZeneca and Daiichi Sankyo have expressed optimism about Datroway’s potential to redefine treatment across various tumor types. The drug is now approved in the U.S. for three indications, including two for breast cancer, reinforcing its role in oncology. The approval follows feedback from medical experts, including Tiffany A. Traina from Memorial Sloan Kettering Cancer Centre, who highlighted the drug’s ability to prolong survival in a historically difficult-to-treat patient group.
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