• The drug, Datroway, is for patients with metastatic triple-negative breast cancer not eligible for immunotherapy.
• A pivotal trial showed the drug extended median overall survival by 5.0 months compared to chemotherapy.
• A U.S. regulatory decision on the first-line treatment is expected in the second quarter of 2026.
WASHINGTON, D.C., United States – A potential new treatment for an aggressive form of breast cancer is a step closer to reaching patients. The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for an application from AstraZeneca and Daiichi Sankyo for their drug, Datroway, as a first-line treatment for certain patients with metastatic triple-negative breast cancer.
A final regulatory decision is anticipated in the second quarter of 2026.
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What is new?
AstraZeneca and Daiichi Sankyo announced on February 3, 2026, that the U.S. FDA has granted Priority Review to their supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan). The application seeks approval for the drug to be used as a treatment for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for immunotherapy. Currently, chemotherapy is the only approved first-line treatment for this patient group, which represents approximately 70% of metastatic TNBC cases.
Key Trial Data
The application is based on results from the TROPION-Breast02 Phase III trial. The study demonstrated that Datroway provided a statistically significant and clinically meaningful 5.0-month improvement in median overall survival compared to chemotherapy. The trial also showed a 43% reduction in the risk of disease progression or death for patients treated with Datroway.
Treatment responses were also more robust and durable, with an objective response rate of 62.5% and a duration of response of 12.3 months for Datroway, compared to 29.3% and 7.1 months for chemotherapy, respectively. The safety profile observed in the trial was consistent with previous studies. These results were presented at the 2025 European Society for Medical Oncology (ESMO) Congress.
Regulatory Path
The FDA grants Priority Review to medicines that could offer significant improvements over available treatments. The action date for the regulatory decision is expected during the second quarter of 2026. Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, stated that Datroway “is the only medicine to significantly improve overall survival compared to chemotherapy in this patient population as demonstrated in the TROPION-Breast02 trial.”
The application is also being reviewed under Project Orbis, a framework for concurrent submission and review of oncology drugs among international partners, aiming to expedite patient access globally. Ken Takeshita, Global Head of R&D at Daiichi Sankyo, noted, “Datroway potentially could be the first medicine approved in the 1st-line setting to significantly extend overall survival and nearly double the time without disease progression or death compared to chemotherapy” for this patient group.
About this company
AstraZeneca is a British-Swedish multinational pharmaceutical and biotechnology company. It is developing Datroway in partnership with Daiichi Sankyo, a global pharmaceutical company with a focus on oncology. The companies are also pursuing additional regulatory submissions for Datroway in breast and lung cancer globally.
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