WILMINGTON, DE — AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application for DATROWAY® (datopotamab deruxtecan-dlnk) has been accepted and granted Priority Review by the U.S. Food and Drug Administration for the treatment of adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy.
The FDA’s Priority Review designation is reserved for medicines that, if approved, would offer significant improvements over available treatment options. The agency’s decision under the Prescription Drug User Fee Act is expected in the second quarter of 2026.
The application is being reviewed under Project Orbis, an international regulatory collaboration designed to accelerate access to promising oncology therapies through concurrent review among global health authorities.
The submission is based on results from the Phase III TROPION-Breast02 trial, which demonstrated that DATROWAY significantly improved overall survival compared with chemotherapy in this patient population. The trial showed a 5.0-month improvement in median overall survival, with a hazard ratio of 0.79 and a statistically significant p-value of 0.0291. Patients receiving DATROWAY also experienced a 43 percent reduction in the risk of disease progression or death compared to chemotherapy.
The therapy achieved an objective response rate of 62.5 percent, compared to 29.3 percent with chemotherapy, and demonstrated a median duration of response of 12.3 months versus 7.1 months. Results were presented at the 2025 European Society for Medical Oncology Congress.
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 additional clinical factors. For these patients, chemotherapy remains the only approved first-line treatment option.
Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca, said DATROWAY is the only medicine to significantly improve overall survival compared with chemotherapy in this population, noting the trial enrolled patients with particularly aggressive disease.
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, said the therapy could become the first medicine approved in the first-line setting to significantly extend survival and nearly double the time without disease progression or death for these patients.
DATROWAY is a TROP2-directed antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca. The companies are also pursuing additional regulatory submissions globally in breast and lung cancer.
DATROWAY 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. Reported risks include interstitial lung disease and pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity. Clinicians are advised to monitor patients for respiratory symptoms, ocular complications, and other serious adverse events and to follow established dose modification guidelines when necessary.
If approved, DATROWAY could establish a new standard of care for patients with metastatic triple-negative breast cancer who currently face limited treatment options.
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