AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Datroway (datopotamab deruxtecan) has been granted Priority Review by the US Food and Drug Administration (FDA) for use as a first-line treatment in adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for immunotherapy, the companies said on Tuesday.
The FDA has accepted the companies’ supplemental Biologics License Application (sBLA), with a regulatory decision expected in the second quarter of 2026, in line with the Prescription Drug User Fee Act timeline. Priority Review is reserved for therapies that may offer significant improvements over existing treatment options in serious conditions.
The application is being reviewed under Project Orbis, an international regulatory initiative that enables concurrent submission and review of oncology medicines across multiple countries to accelerate patient access.
If approved, Datroway could become the first medicine to significantly improve overall survival compared with chemotherapy in the first-line setting for patients with metastatic TNBC who cannot receive PD-1 or PD-L1 inhibitor therapy. Around 70% of patients with metastatic TNBC fall into this category, including those with PD-L1–negative tumours and those unable to receive immunotherapy due to prior treatment, comorbidities or limited access. Currently, chemotherapy is the only approved first-line option for these patients.
The sBLA is supported by results from the global Phase III TROPION-Breast02 trial, which demonstrated that Datroway achieved a statistically significant and clinically meaningful improvement in overall survival, extending median survival by 5.0 months compared with chemotherapy. The trial also showed a 43% reduction in the risk of disease progression or death, alongside improved progression-free survival.
Patients treated with Datroway showed higher and more durable responses, with an objective response rate of 62.5%and a median duration of response of 12.3 months, compared with an objective response rate of 29.3% and duration of response of 7.1 months for chemotherapy. These findings were presented at the 2025 European Society for Medical Oncology (ESMO) Congress. The safety profile observed in the trial was consistent with earlier Datroway studies in breast cancer.
TROPION-Breast02 enrolled 644 patients across Africa, Asia, Europe, North America and South America, including individuals with aggressive disease features such as stable brain metastases. The study compared Datroway with investigator’s choice of chemotherapy in previously untreated patients with locally recurrent inoperable or metastatic TNBC who were not candidates for immunotherapy.
Datroway is a TROP2-directed DXd antibody-drug conjugate, discovered by Daiichi Sankyo and jointly developed and commercialised with AstraZeneca. TROP2 is widely expressed in several solid tumours, including TNBC, and is associated with tumour progression and poor survival outcomes.
The therapy is already approved in more than 40 countries for certain forms of hormone receptor-positive, HER2-negative metastatic breast cancer and is available in the US under accelerated approval for EGFR-mutated non-small cell lung cancer, with confirmatory trials ongoing.
Additional regulatory submissions for Datroway in breast and lung cancer indications are currently underway globally, as part of a broader clinical development programme spanning more than 20 trials across multiple tumour types.
