AstraZeneca and Daiichi Sankyo have announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to their supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan) for the treatment of adult patients with unresectable or metastatic Triple-Negative Breast Cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitor therapy. The FDA grants Priority Review to medicines that may offer significant improvements in safety or efficacy compared to existing treatment options. The Prescription Drug User Fee Act (PDUFA) action date for the regulatory decision is anticipated in the second quarter of 2026. The application is also being reviewed under Project Orbis, a global initiative designed to enable concurrent review of oncology medicines across international regulatory authorities and accelerate patient access to innovative cancer therapies.

The submission is based on results from the Phase III Tropian-Breast02 trial, which evaluated Datroway as a first-line treatment in patients with metastatic TNBC who were not candidates for immunotherapy. The study demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival compared to chemotherapy, with a hazard ratio of 0.79. 

Datroway also reduced the risk of disease progression or death by 43 percent, with a hazard ratio of 0.57. The therapy showed more robust and durable responses, achieving an objective response rate of 62.5 percent and a median duration of response of 12.3 months, compared to 29.3 percent and 7.1 months respectively with chemotherapy. The safety profile was consistent with previous clinical trials of Datroway in breast cancer. These findings were presented at the 2025 European Society for Medical Oncology (ESMO) Congress.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca, stated that Datroway is the only medicine to significantly improve overall survival compared to chemotherapy in this patient population, highlighting that the results are particularly notable given the aggressive nature of the disease in enrolled patients. She added that the Priority Review and Project Orbis evaluation reflect a shared commitment to bringing the treatment to patients globally as quickly as possible. 

Ken Takeshita, Global Head of R&D at Daiichi Sankyo, said Datroway has the potential to become the first medicine approved in the first-line setting to significantly extend overall survival and nearly double progression-free survival compared to chemotherapy in patients with metastatic TNBC who cannot receive immunotherapy.

Triple-negative breast cancer accounts for approximately 15 percent of all breast cancer cases worldwide, with around 345,000 diagnoses each year. In the United States alone, between 32,000 and 48,000 cases were diagnosed in 2025. TNBC is more frequently diagnosed in younger and premenopausal women and is disproportionately prevalent among Black and Hispanic women. It is considered one of the most aggressive forms of breast cancer, with a median overall survival of 12 to 18 months in the metastatic setting and a five-year survival rate of only about 15 percent. Approximately 70 percent of patients with metastatic TNBC are not eligible for immunotherapy, leaving chemotherapy as the only approved first-line treatment option. Due to the absence of oestrogen receptors, progesterone receptors and HER2 expression, TNBC remains particularly challenging to treat.