The U.S. Food and Drug Administration (FDA) has accepted a supplemental biologics license application and granted priority review for Datroway (datopotamab deruxtecan), AstraZeneca announced. The therapy is intended for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor treatment.
This milestone targets a patient population that currently relies on chemotherapy as the only approved first-line option. The regulatory decision follows the 2025 European Society for Medical Oncology Congress and sets a potential FDA action date in the second quarter of 2026.
Priority Review and Project Orbis
Priority review is granted to drugs that may offer significant improvements over existing treatments, such as enhanced safety, efficacy, or patient adherence. Datroway’s application is also being evaluated under Project Orbis, an international initiative that allows multiple countries to review oncology therapies concurrently, accelerating access to effective cancer treatments.
Triple-Negative Breast Cancer: A Difficult-to-Treat Form
TNBC is an aggressive subtype of breast cancer that lacks estrogen receptors, progesterone receptors, and HER2 overexpression, making it difficult to treat. While immunotherapy combined with chemotherapy has improved outcomes for some patients, around 70% of metastatic TNBC patients are ineligible for immunotherapy, including those whose tumors do not express PD-L1 or who have other medical contraindications.
Clinical Trial Results
The FDA submission is supported by data from the Phase 3 TROPION-Breast02 trial, which showed that Datroway significantly improved survival outcomes compared to standard chemotherapy. Key findings include:
- Median overall survival: Extended by five months in the Datroway group
- Progression-free survival: Risk of disease progression or death reduced by 43%
- Objective response rate: 62.5% with Datroway vs. 29.3% for chemotherapy
- Duration of response: Median of 12.3 months vs. 7.1 months with chemotherapy
About the TROPION-Breast02 Trial
This global, multicenter, randomized, open-label Phase 3 study enrolled 644 patients across Africa, Asia, Europe, North and South America. The trial focused on individuals with previously untreated, locally recurrent inoperable or metastatic TNBC who could not receive immunotherapy.
Participants included patients with de novo or recurrent disease and those with poor prognostic factors, such as stable brain metastases. Eligible patients received either Datroway or an investigator’s choice of chemotherapy, including paclitaxel, nab-paclitaxel, capecitabine, carboplatin, or eribulin.
Datroway is a TROP2-directed antibody-drug conjugate (ADC). TROP2 is widely expressed in solid tumors, including TNBC, and is linked to tumor progression and poor survival outcomes. The trial’s dual primary endpoints were progression-free survival and overall survival.
Safety Profile
Datroway’s safety in TROPION-Breast02 remained consistent with previous studies in breast cancer. The therapy, discovered by Daiichi Sankyo and co-developed with AstraZeneca, is already approved in over 40 countries for HR-positive, HER2-negative breast cancer and holds accelerated approval in the U.S. for certain lung cancers. Continued monitoring of safety is part of the FDA’s review of this supplemental application.
