Datroway Receives Priority Review for Metastatic Triple-Negative Breast Cancer

AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has been granted Priority Review by the Food and Drug Administration (FDA) as a first-line treatment for patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for immunotherapy. The FDA’s decision, announced on February 3, 2026, is based on positive results from the TROPION-Breast02 trial, which demonstrated a significant improvement in overall survival compared to chemotherapy in this patient population .

Understanding Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is an aggressive form of breast cancer characterized by the lack of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) expression . This distinct profile historically meant limited targeted therapy options were available. TNBC accounts for approximately 10-20% of all breast cancer diagnoses and disproportionately affects Black women and those diagnosed before menopause .

The Necessitate for New Treatment Options

Currently, chemotherapy has been the mainstay of systemic treatment for localized TNBC . However, approximately 70% of patients with metastatic TNBC are not eligible for immunotherapy, often due to lack of PD-L1 expression or other health factors . This leaves a significant unmet need for effective first-line therapies.

Datroway: A Potential New Standard of Care

Datroway is a targeted antibody drug conjugate (ADC) designed to deliver chemotherapy directly to cancer cells. The TROPION-Breast02 trial results suggest that, if approved, Datroway could develop into the new standard of care for first-line treatment of metastatic TNBC patients ineligible for immunotherapy .

FDA Review and Timeline

The FDA has granted Priority Review to the sBLA for Datroway, which means the agency will expedite its review process. The Prescription Drug User Fee Act (PDUFA) date, indicating the FDA’s expected action date, is in the second quarter of 2026 . The application is also being reviewed under Project Orbis, a program designed to accelerate the development and approval of oncology medicines internationally.

Recent Advances in TNBC Treatment

The treatment landscape for TNBC is evolving. Recent advancements include the addition of pembrolizumab to neoadjuvant chemotherapy, which has improved event-free survival for stage II–III TNBC . Ongoing research focuses on identifying biomarkers to predict which patients will benefit most from immunotherapy and optimizing treatment combinations, including capecitabine and olaparib .