Datroway granted priority review by FDA as first line treatment for patients with metastatic triple-negative breast cancer
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 Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the second quarter of 2026 (set for Jun 02, 2026). Potential EU approval in Q3 2026, and CN approval in Q4 2026 expected.
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.
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.
Breast Cancer development updates
- P3 DESTINY-Breast06: T-DXd in chemo-naïve HR+/HER2-low/ultralow mBC
- Received regulatory approval in China in Q4 2025
- P3 TROPION-Breast02: Dato-DXd in 1L TNBC not candidates for anti-PD-(L)1
- Regulatory filing in US, EU and CN with approvals guided in 2026
- FDA PDUFA set for Jun 02, 2026
- Regulatory filing in US, EU and CN with approvals guided in 2026
- P3 TROPION-Breast03: Dato-DXd ± durvalumab in Stage I-III TNBC without pCR, post-neoadjuvant therapy
- Readout guided for 2027
- P3 TROPION-Breast04: Neoadjuvant/adjuvant Dato-DXd + durvalumab in Stage I-III TNBC or HR-low/HER2- BC
- Readout guided for >2027
- P3 TROPION-Breast05: Dato-DXd ± durvalumab in 1L PD-L1+ CPS ≥ 10 TNBC
- Readout guided for 2027
- P3 SERENA-4: Camizestrant (oral SERD) + palbociclib in 1L ER+/HER2- mBC
- Readout remains guided for H2 2026
- AZ noted the trial was designed to enrich for an ET–sensitive population, where it believes camizestrant will be most effective
- P3 SERENA-6: Camizestrant + CDK4/6i in 1L ESR1m HR+/HER2- mBC
- Regulatory approvals in the US, EU and JP continues to be expected in H1 2026