AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the second quarter of 2026.
The sBLA is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. This initiative is designed to bring effective cancer treatments to patients as early as possible.
Approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy, including all patients whose tumours do not express PD-L1 as well as patients with PD-L1-expressing tumours who cannot receive immunotherapy due to other factors. Chemotherapy remains the only approved 1st-line treatment for these patients.1,2
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "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 results of which are even more striking considering the trial enrolled a subset of patients with highly aggressive disease. The Priority Review of our submission underscores the impact of these results and its review under Project Orbis signals a widely shared commitment to bringing Datroway to patients around the world as quickly as possible."
Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "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 in patients with metastatic triple-negative breast cancer for whom immunotherapy was not an option. We are eager to work with the FDA to bring this much needed treatment option to patients with metastatic triple-negative breast cancer."
The sBLA is based on results from the TROPION-Breast02 Phase III trial which showed Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0291) and a 43% reduction in patients' risk of disease progression or death (HR 0.57; 95% CI 0.47-0.69; p<0.0001) compared to chemotherapy as 1st-line treatment in this patient population. Datroway was also associated with more robust and durable treatment responses, including an objective response rate (ORR) of 62.5% and duration of response (DoR) of 12.3 months, compared to an ORR of 29.3% and DoR of 7.1 months with chemotherapy. These results were presented at the 2025 European Society for Medical Oncology (ESMO) Congress.
The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer.
Additional regulatory submissions for Datroway in breast and lung cancer are underway globally.
Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
Notes
Triple-negative breast cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4 In the US, an estimated 32,000 to 48,000 cases of TNBC were diagnosed in 2025.5,6 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.7-9 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.7,10,11
While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.7 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.7 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.12,13 However, for the approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy remains the only approved 1st-line treatment.1,2
TROP2 is a protein broadly expressed in several solid tumours including TNBC.14 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.15,16
TROPION-Breast02
TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator's choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.
The dual primary endpoints of TROPION-Breast02 are PFS as assessed by blinded independent central review and OS. Secondary endpoints include PFS as assessed by investigator, ORR, DoR, disease control rate, pharmacokinetics and safety.
