USFDAMay 26, 2026, 07:26 AM
AstraZeneca's Datroway Approved in US for 1st-Line TNBC
AI Summary
AstraZeneca and Daiichi Sankyo's Datroway has received US FDA approval for the 1st-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. This marks Datroway as the first TROP2-directed antibody drug conjugate approved for this specific patient population, offering a new standard of care beyond traditional chemotherapy. The approval is based on results from the TROPION-Breast02 Phase III trial, which demonstrated significant improvements in overall survival and progression-free survival.
Key Highlights
- Datroway approved in the US for 1st-line metastatic triple-negative breast cancer (TNBC) patients not eligible for PD-1/PD-L1 inhibitors.
- First TROP2-directed antibody drug conjugate to prolong overall survival in this setting.
- Demonstrated a 5.0-month improvement in median overall survival (OS) versus chemotherapy.
- Reduced risk of disease progression or death by 43% (HR 0.57) compared to chemotherapy.
- Achieved an objective response rate (ORR) of 64% for Datroway versus 30% for chemotherapy.
- Included in NCCN Clinical Practice Guidelines as a Category 1 Preferred 1st-line treatment option.
- Datroway is now approved for three indications in the US, including two for breast cancer.
Price Impact
More from AZN