AstraZeneca and Daiichi Sankyo announced that the U.S. Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan) for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor therapy, potentially reshaping treatment options for a patient population with historically limited choices.
The approval follows the FDA’s Priority Review of the companies’ application and is based on results from the Phase III TROPION-Breast02 clinical trial, which demonstrated significant survival benefits over standard chemotherapy. Trial findings were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.
Datroway becomes the first and only TROP2-directed antibody-drug conjugate (ADC) to demonstrate a statistically significant improvement in overall survival in the first-line treatment setting for metastatic TNBC patients who are ineligible for immunotherapy. The therapy also represents the first medicine to significantly extend survival beyond chemotherapy in this specific patient group, positioning it as a potential new standard of care.
Triple-negative breast cancer is among the most aggressive forms of breast cancer and is particularly difficult to treat because tumors lack expression of estrogen, progesterone, and HER2 receptors, limiting the availability of targeted therapies. Patients with metastatic disease often face poor prognoses, and for those unable to receive immunotherapy, chemotherapy has traditionally remained the only frontline treatment option.
According to AstraZeneca and Daiichi Sankyo, approximately seven out of ten patients with metastatic TNBC are not eligible for immunotherapy, leaving a substantial unmet medical need.
In the TROPION-Breast02 trial, Datroway achieved a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy. Patients receiving Datroway experienced a median overall survival benefit of five months, with results translating to an unprecedented median survival of approximately two years in the first-line metastatic setting. The therapy reduced the risk of death by 21%, reflected by a hazard ratio of 0.79.
Datroway also demonstrated strong disease control benefits, reducing the risk of disease progression or death by 43% compared with chemotherapy. Median progression outcomes favored the investigational ADC, with a hazard ratio of 0.57 and high statistical significance.
Treatment responses were also notably stronger among patients receiving Datroway. The trial reported an objective response rate of 64%, more than double the 30% response rate observed in patients treated with chemotherapy.
Importantly, the safety profile of Datroway was consistent with previous breast cancer studies, with no unexpected safety signals reported, reinforcing confidence in the treatment’s tolerability profile.
Tiffany A. Traina, section head of the Triple-Negative Breast Cancer Clinical Research Programme at Memorial Sloan Kettering Cancer Center and a TROPION-Breast02 investigator, said the approval introduces the first therapy to significantly prolong survival compared with chemotherapy in this patient setting and offers a much-needed treatment alternative.
Patient advocacy groups also welcomed the decision. Arlene Brothers, executive director of the Triple Negative Breast Cancer Foundation, said the approval gives patients access to a frontline option beyond conventional chemotherapy for the first time.
Executives at AstraZeneca and Daiichi Sankyo emphasized the therapy’s broader potential in oncology. Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Haematology Business Unit, said the approval addresses an urgent need for more durable and effective therapies for patients with advanced TNBC. Ken Keller, global head of oncology business at Daiichi Sankyo, described Datroway as a therapy capable of redefining the treatment landscape for metastatic TNBC.
The approval was reviewed under Project Orbis, an international regulatory collaboration intended to accelerate patient access to oncology medicines. Reviews are ongoing in Australia, Canada, Singapore, and Switzerland, while regulatory assessments continue in the European Union, China, and Japan.
Datroway has also been added to the NCCN Clinical Practice Guidelines in Oncology as a Category 1 preferred first-line treatment option for metastatic TNBC patients who are not candidates for immunotherapy, further supporting its role as a new frontline standard of care.