FDA Approves AstraZeneca and Daiichi Sankyo's Datroway for First-Line Triple-Negative Breast Cancer
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
The U.S. Food and Drug Administration has approved AstraZeneca and Daiichi Sankyo's Datroway (datopotamab deruxtecan) for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/L1 inhibitors. The approval, announced on May 22, makes Datroway the first TROP2-directed antibody-drug conjugate (ADC) to demonstrate an overall survival benefit versus chemotherapy in this first-line setting.
The approval is based on results from the Phase III TROPION-Breast02 trial, which showed that Datroway reduced the risk of death versus chemotherapy by 21%, extending median overall survival by five months to 23.7 months (hazard ratio of 0.79; p=0.0291). Patients receiving Datroway also experienced a 43% reduction in the risk of disease progression or death compared to chemotherapy. The objective response rate was 62.5% versus 29.3% with chemotherapy, and the median duration of response was 12.3 months compared to 7.1 months. Results were presented at the 2025 European Society for Medical Oncology (ESMO) Congress.
Approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy, including those whose tumors do not express PD-L1 and others who cannot receive immunotherapy due to additional clinical factors. For these patients, chemotherapy had remained the only approved first-line treatment option.
The application was reviewed under Project Orbis, which facilitates concurrent submission and review among international regulators. As part of that initiative, Datroway's case is also being evaluated in Australia, Canada, Singapore, and Switzerland, with additional reviews underway in the European Union, China, and Japan.
Both Datroway and Gilead Sciences' Trodelvy had previously been added to National Comprehensive Cancer Network (NCCN) guidelines with the highest category 1 preferred regimen recommendations in first-line TNBC. Gilead's rival TROP2 ADC, Trodelvy, did not meet statistical significance on overall survival in its Ascent-03 study in a similar first-line TNBC setting among patients not eligible for anti-PD-1/L1 treatments. However, Gilead has submitted both the Ascent-03 and Ascent-04 indications with the FDA, with a decision expected in the second half of 2026.
A third TROP2 ADC, Kelun-Biotech's Merck-partnered sacituzumab tirumotecan (sac-TMT), recently reported a positive Phase III readout in China in first-line TNBC, and Merck's global Phase III TroFuse-011 study is testing sac-TMT both as a monotherapy and in combination with Keytruda in PD-L1-negative TNBC.
Datroway is a TROP2-directed ADC discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca. It is currently approved under accelerated approval for certain patients with EGFR-mutated non-small cell lung cancer and for unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer following prior therapy. The safety profile observed in TROPION-Breast02 was consistent with previous trials, with reported risks including interstitial lung disease and pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity.