WILMINGTON, Del. — AstraZeneca and Daiichi Sankyo said the U.S. Food and Drug Administration has accepted and granted Priority Review to a supplemental Biologics License Application for DATROWAY (datopotamab deruxtecan-dlnk) as a first-line treatment for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy.
Priority Review is granted to medicines that, if approved, would offer significant improvements over available treatment options by demonstrating meaningful gains in safety or efficacy, preventing serious conditions, or improving patient compliance. The FDA action date for its regulatory decision is expected in the second quarter of 2026 under the Prescription Drug User Fee Act timeline.
The application is being reviewed under Project Orbis, a framework that enables concurrent submission and review of oncology medicines among international regulatory partners to help accelerate patient access to effective cancer treatments.
Company officials noted that approximately 70 percent of patients with metastatic triple-negative breast cancer are not candidates for immunotherapy, including those whose tumors do not express PD-L1 and others who cannot receive immunotherapy due to clinical factors. For these patients, chemotherapy remains the only approved first-line treatment option.
Susan Galbraith, executive vice president of oncology haematology research and development at AstraZeneca, said DATROWAY is the only medicine to demonstrate a significant improvement in overall survival compared with chemotherapy in this patient population, based on results from the TROPION-Breast02 trial. She added that the Priority Review decision reflects the impact of the data and that review under Project Orbis underscores a shared commitment to making the treatment available to patients globally as quickly as possible.
Ken Takeshita, global head of research and development 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 the time patients live without disease progression or death compared with chemotherapy in this group. He said the company looks forward to working with the FDA to bring the treatment to patients with metastatic triple-negative breast cancer.
The submission is based on results from the Phase III TROPION-Breast02 trial, which showed DATROWAY achieved a statistically significant and clinically meaningful 5.0-month improvement in median overall survival compared with chemotherapy. The trial also demonstrated a 43 percent reduction in the risk of disease progression or death, along with higher and more durable response rates. These findings were presented at the 2025 European Society for Medical Oncology Congress.
The safety profile observed in the trial was consistent with prior DATROWAY studies in breast cancer. Additional regulatory submissions for DATROWAY in breast and lung cancer indications are currently underway worldwide.
DATROWAY is a TROP2-directed antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca.
